Abstract
Purpose
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The use of non-biodegradable suture anchors (NBSA) in arthroscopic rotator cuff repair (RCR) has increased significantly. However, several complications such as migration, chondral damage, revision, and imaging difficulties have been reported. Meanwhile, the effectiveness of biodegradable suture anchors (BSA) in overcoming such complications and achieving functional outcomes requires further study. Thus, we aim to compare the clinical outcomes and complications of RCR using BSA and NBSA using direct comparison studies.
Methods
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Two independent reviewers conducted systematic searches in PubMed, Embase, Cochrane Library, and Web of Science from conception to September 2022. Using the RoB 2 and ROBINS-I tools, we assessed the included studies for bias. We applied GRADE to appraise our evidence. Our PROSPERO registration number is CRD42022354347.
Results
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Six studies (two randomized controlled trials, one retrospective cohort, and three case–control studies) involving 423 patients were included (211 patients received BSA and 212 patients received NBSA). BSA was comparable to NBSA in forward flexion, abduction, external rotation, Constant–Murley score, and perianchor cyst formation (P = 0.97, 0.81, 0.56, 0.29, and 0.56, respectively). Retear rates were slightly higher while tendon healing was reduced in BSA compared to NBSA, but the differences were not significant (P = 0.35 and 0.35, respectively).
Conclusion
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BSA and NBSA appear to yield similar shoulder functions and complications in rotator cuff repairs.
Introduction
Rotator cuff (RC) tears, one of the most common causes of shoulder pain and dysfunction, range from partial to full thickness (1, 2). Approximately 20% of the general population suffers from full-thickness RC tears, but this figure increases for older patients. Moreover, 32% of patients suffering from traumatic shoulder injuries who could not abduct their arms above 90° had full-thickness RC tears (3, 4, 5). RC tears are repaired either by open, mini-open, or arthroscopic surgeries. The less invasive procedure has less pain after surgery than open surgery. It also has faster rehabilitation, functional recovery, and return to work and sports following surgery (6, 7).
Through the use of suture anchors in arthroscopic RC procedures, it has been possible to transition from open surgery to arthroscopic procedures (8). The suture anchor revolutionized orthopedic surgery by providing a convenient and efficient method of fixing soft tissues to bone (9). As anchor technology has evolved over the past decade, their designs have evolved to maximize the effectiveness of each anchor type (10). For full-thickness RC tears, suture anchors are generally used to restore tissue and bone in a secure and effective manner (11). An ideal suture anchor should be easy to use, strong, abrasion-proof, and absorbable without the complications of dissolving materials (7, 12).
Suture anchors are commonly made from nonbiodegradable and biodegradable materials. Nonbiodegradable suture anchor (NBSA), particularly metallic ones, has been demonstrated to be capable of optimizing tissue healing and long-term fixation, as well as ensuring optimal tissue healing (13). However, NBSA has been associated with loosening migration, incarceration of implants in joints, chondral damage, and difficulties in revision surgeries and imaging studies (14, 15, 16). Another type of NBSA, namely, polyetheretherketone (PEEK), has poor osseointegration but has advantages over other suture anchor materials, i.e. favorable postoperative imaging and stable fixation. Furthermore, the development of all-soft suture anchors (ASA) that are made from ultra-high-molecular-weight polyethylene (UHMWPE) sutures may minimize complications and invasiveness associated with solid-type anchors but provide a weaker fixation (12, 17).
On the other hand, biodegradable suture anchors (BSA) are easier to revise than NBSA, offer better postsurgical imaging, are more biocompatible, and require no removal procedure compared to NBSA (12, 18). Recent BSA are made of polyglycolic acid (PGA), poly-l-lactic acid (PLLA), and biocomposite materials containing osteoconductive factors such as β-tricalcium phosphate (β-TCP) and hydroxyapatite (19, 20, 21). While arthroscopic RC repair (RCR) surgery utilizes BSA to circumvent the complications associated with metallic suture anchors, they have been reported to cause an inflammatory response, leading to early fixation loss and inadequate tissue repair (22, 23). The ideal BSA would provide all of the benefits of the materials without any complications. However, such an anchor has yet to be developed, so orthopedic surgeons should select the appropriate suture anchor materials by considering their benefits and drawbacks (12). To our knowledge, there is no systematic review and meta-analysis comparing BSA and NBSA for RC repair in the literature. Thus, we aim to compare the clinical outcomes and complications of RC tear repair using BSA and NBSA based on direct comparative studies.
Methods
In accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 guidelines (24) and Cochrane Handbook of Systematic Reviews of Interventions (25), the full protocol for this systematic review has been registered in PROSPERO (registration number CRD42022354347) (26).
Eligibility criteria
We included head-to-head direct comparative studies of BSA vs NBSA in RC tears surgery that assessed functional outcomes (patient-reported outcome measures/PROMs, range of motion/ROM) and complications. Randomized controlled trials (RCT) and quasi-RCT/controlled clinical trials (CCT), cohort/longitudinal comparative studies, and case–control studies were included. Publication dates were not restricted in this study. We examined all published English-language articles that were accessible in full text for analysis. However, we excluded studies dealing with other shoulder injuries or other shoulder instability. We also excluded case series, case reports, reviews, systematic reviews, meta-analyses, editorials, letters, book chapters, study protocols, nonclinical/preclinical studies (in vitro, cadavers, animals) and conference abstracts that did not include full reports.
Electronic search
A systematic search of the electronic literature was carried out by the authors in the following databases:
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MEDLINE (PubMed): 1993 to present (September 7, 2022)
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Embase (Ovid): 1980 to present (September 7, 2022)
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CENTRAL (Cochrane Library): from inception to present (September 7, 2022)
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Web of Science: 1993 to present (September 7, 2022)
Our search was performed using both free text (title/abstract/keywords) in all databases and subject headings in MEDLINE (MeSH) and Embase (Emtree). A comprehensive list of keywords and search strategies was provided in the Appendix (see section on supplementary materials given at the end of this article) in order to provide detailed information concerning keywords and search strategies. We derived our search strategy by applying the appropriate Boolean operators (‘AND’, ‘OR’, ‘NOT’) to queries based on the PICO concept (Populations, Intervention, Comparison, Outcome). The concept keywords were added by ‘AND’ and the connected keywords by ‘OR.’ A study population comprised RC tears patients who had undergone RC surgery. For the purpose of collecting the largest amount of relevant literature possible, we employed extensive word variations, truncations (*), and phrase searching (“”). The balance between sensitivity and specificity was maintained. Several common materials in BSA (e.g. PGA, PLLA, and biocomposite materials) and NBSA (e.g. titanium, PEEK, and UHMWPE) were also included in the keywords.
Study selection and data extraction
We exported the references to Rayyan (27) for duplicate detection, and then two independent reviewers (HS and BAS) screened them using Rayyan (27) for their titles and abstracts. For full-text reading, articles that meet our inclusion criteria were marked as ‘included,’ while articles that do not meet our criteria were marked as ‘excluded.’ Uncertain studies were marked ‘maybe’ and discussed. To determine whether the potentially eligible studies met the inclusion criteria, the reviewers conducted a thorough review. A third reviewer (SKS) resolved any discrepancies that may have occurred during the selection process. All references were also checked for possible additional relevant studies. Figure 1 outlines our workflow according to PRISMA 2020 (24).
Study selection flow diagram by PRISMA flow chart.
Citation: EFORT Open Reviews 8, 10; 10.1530/EOR-23-0012
Standardized data extraction was performed using Microsoft Excel (Microsoft Corporation, USA). We collected the following data: author, publication year, country, study design, level of evidence, number of patients, number of suture anchors, patient demographics (age and sex), RC tear size, surgical techniques, outcomes evaluation procedures, rehabilitation procedures, suture anchor characteristics (material, dimension, manufacturer), follow-up duration, shoulder ROM, Constant–Murley score (CMS), American Shoulder and Elbow Surgeons (ASES) scores, tendon healing assessment, complications (perianchor cyst formation/PCF, retear rate, and other complications), and conclusions.
Risk of bias assessment
We assessed randomized controlled trials (RCTs) using the Cochrane Risk of Bias (RoB) 2 tool (28). Non-RCTs were assessed using the Risk Of Bias In Non-Randomized Studies of Intervention (ROBINS-I) tool (29). The bias assessment summary was visualized Using the Risk-of-Bias Visualization (Robvis) tool (30). A robust meta-analysis was performed using only studies with moderate or better bias. Funnel plots and Egger’s tests were planned when a minimum of ten studies were included; otherwise, they have insufficient power to detect reporting bias objectively (31).
Synthesis of results
As a primary outcome, shoulder range of motion (ROM) in forward flexion, abduction, external rotation, and internal rotation were assessed. Secondary outcomes included the Constant–Murley score (CMS), American Shoulder and Elbow Surgeons (ASES) scores, tendon healing, and complications (PCF, retear, and other complications). Continuous data were reported in mean difference (MD) with a 95% confidence interval (CI), while dichotomous data were reported in odds ratio (OR). For heterogeneity analysis, Cochran’s Q and I 2 tests were conducted. The random effect model was chosen when we suspected heterogeneity (Cochran’s Q test < 0.1 and I 2 > 50%). Otherwise, the fixed effect model was used. Additionally, a subgroup analysis (based on study designs, material subtypes, and surgery techniques) was planned when we encountered heterogeneity. In case of unresolved heterogeneity problems after a subgroup analysis, a meta-regression was planned when a minimum of ten studies were included (32). All statistical analysis was performed using RevMan 5.3 (The Nordic Cochrane Center, Denmark).
Evidence quality assessment
We evaluated our evidence quality using the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) approach recommended by the Cochrane Methods (33, 34, 35). The GRADE approach assesses five domains of quality: the risk of bias for an individual study is assessed by RoB2 and ROBINS-I tools; inconsistency is detected by heterogeneity test; indirectness is measured based on whether the PICO elements are easily recognizable in order to answer our review question, imprecision is determined by evaluating the sample size, and other factors (34).
Results
Study selection
We retrieved 554 records from four databases using search strategies after removing 218 duplicate articles by checking title and abstract similarity. Two independent reviewers selected 11 studies for full-text article evaluation after screening 331 records based on title and abstract. We excluded five studies (36, 37, 38, 39, 40). These studies were made up of three studies where two types of suture anchors were used in one group of patients; one study was a noncomparative study, and one study used unequal group comparisons. The flowchart of the PRISMA method (24) (Fig. 1) contains detailed information regarding the selection process for six included studies for analyses.
Study characteristics
A total of six studies were selected: two randomized clinical trials (41, 42), one retrospective cohort study (43), and three case–control studies (44, 45, 46). In all of the studies analysed in our review, 556 suture anchors were used. We analysed 423 patients aged 60.54 ± 8.60 years, ranging from 29 to 80 years, although only two studies provided age ranges (42, 46). From all included patients, 211 patients received BSA and 212 patients received NBSA. In the BSA group, the majority was male (51.75%), whereas in NBSA, the majority was female (51.41%), although the differences were almost neglectable. All studies comprised full-thickness RC tears. One study (41) found that all included subjects had small to medium-sized full-thickness RC tears, despite the inclusion criteria of partial thickness RC tears being stated. Table 1 shows detailed patient characteristics.
Summaries of study and patient characteristics.
| Reference | Country | Study design | LOE | Patients, n | Suture anchors, n | Patient demographics | Rotator cuff tear size | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| BSA (n) | NBSA (n) | Age (years) | ||||||||||||
| Total | Male | Female | Total | Male | Female | BSA | NBSA | |||||||
| Kim et al. (41) | South Korea | RCT | I | 69 | 69 | 33 | 15 | 18 | 36 | 12 | 24 | 60.9 ± 7.2 | 60.0 ± 6.7 | Small to medium size full-thickness tear |
| Milano et al. (42) | Italy | RCT | I | 101 | 101 | 49 | 35 | 14 | 52 | 31 | 21 | 62.8 ± 7.9 | 60.4 ± 8.6 | Full-thickness tear |
| Haneveld et al. (44) | Germany | CCS | III | 36 | 125 | 16 | 10 | 6 | 20 | 16 | 4 | 60.5 ± 6.8 | 60.1 ± 9.7 | Repairable superior full-thickness tear |
| Ro et al. (45) | South Korea | CCS | III | 76 | 76 | 36 | 11 | 25 | 40 | 11 | 29 | 61.4 ± 7.8 | 64.8 ± 5.3 | Small to massive medium size full-thickness tear |
| Benedetto et al. (43) | Italy | RTC | II | 33 | 33 | 18 | 11 | 7 | 15 | 7 | 8 | 58.16 ± 8.2 | 67.1 ± 11.9 | Full-thickness tear max. 4 cm |
| Longo et al. (46) | Italy | CCS | III | 108 | 152 | 59 | 27 | 32 | 49 | 26 | 23 | 58.1 ± 9 | 56.5 ±10 | Full-thickness tear |
BSA, biodegradable suture anchor; CCS, case–control study; LOE, level of evidence; NBSA, nonbiodegradable suture anchor; RCT, randomized controlled trial; RTC, retrospective cohort.
Each study included a detailed description of the surgical procedure used, including imaging evaluations and rehabilitation procedures (Table 2). In general, the majority of the included studies utilized single-row repair techniques (4/6 studies, 67%) (41, 42, 45, 46), one study (44) used a double-row repair technique, while Benedetto et al. did not report the repair technique they used (43). As for the rehabilitation procedures, three studies (42, 44, 46) employed a sling for 3–6 weeks following surgery, one study (46) added an abduction pillow, while Kim et al. (41) used an abduction brace for 1 month following surgery. Motion exercises (passive, active-assisted, and active) were used to implement all rehabilitation programs in all studies (41, 42, 43, 44, 45, 46), with two studies (41, 45) supplementing with pendulum exercises for 3–8 weeks. Following surgery, advanced active movement and strengthening programs were initiated gradually during the 10–16 weeks post operative period, while two studies (41, 45) reported that competitive sports activities were initiated 6 months following surgery. Rehabilitation programs were not detailed in one study (43).
Summaries of rotator cuff tear size, surgical technique, imaging evaluation, and rehabilitation within studies.
| Reference/surgical technique | Rehabilitation | Outcomes evaluation | |||
|---|---|---|---|---|---|
| Functional | Radiological | Evaluator | |||
| Kim et al. (41) |
|
ROM was measured with a goniometer. A functional outcome evaluation was conducted preoperatively, at 3, 6, and 12 months after surgery, and at the last follow-up. Pain was measured using a VAS. | Using a 128-detector CT scan to evaluate bone growth into the anchor and cyst formation around the anchor. A cyst: a gap over 1 mm between the anchor and the bone on at least one CT image. Retear rates were also evaluated with MRI/USG at 12 months postoperatively. | A physician blinded to the study evaluated the functional outcomes. Two blinded orthopedic surgeons with 10 and 7 years of experience measured the radiological outcomes independently. | |
| Main | Arthroscopic surgery with modified Mason–Allen single-row repair technique with one suture anchor (partial thickness and small-sized full-thickness tears) and transosseous equivalent suture bridge repair (medium-sized full-thickness tears) | ||||
| Additional | Subacromial bursectomy, then acromioplasty was performed to decompress bony spurs of type 2 dan type 3 acromion. | ||||
| Milano et al. (42) |
|
Using subjective DASH questionnaire and work-DASH and objective questionnaires CMS. | Not performed | Both baseline and follow-up objective evaluations were performed by blinded assessors. | |
| Main | A single-row method with two Different techniques according to the tear patterns: tendon-to-bone technique using suture anchor for smaller tears and a combination of tendon-to-bone with side-to-side repair for larger tears. | ||||
| Additional | Arthroscopic tendon edges debridement and decortication of greater tuberosity. | ||||
| Haneveld et al. (44) |
|
By means of the SSV, the CMS and the WORC | A 1.5-T MRI system (Signa Twin Speed, General Electric, Milwaukee, WI, USA). Data analysis using the software program ‘Functool 2.5.24’ (General Electric) |
NR | |
| Main | Arthroscopic modified double-row SutureBridge technique | ||||
| Additional | A tenotomy or knotless anchor tenodesis for biceps pathology and acromial decompression | ||||
| Ro et al. (45) | A standard procedure of arthroscopic single-row repair using 3 ‘sister portals’ with 1–3 suture anchors depending on tear size |
|
VAS scores, ROM, muscle strength, and total Constant scores were measured preoperatively and postoperatively. | A 3.0-T MRI system (Achieva; Philips Medical Systems, Best, The Netherlands) and dedicated shoulder coils (4-channel SENSE shoulder coils [Philips Medical Systems] for the 3.0-T system) measured minimum 6 months postoperatively. | A qualified independent examiner with over 3 years’ experience measuring range of motion and muscle strength. A postoperative MRI was assessed and recorded independently by two investigators. |
| Benedetto et al. (43) | NR | NR | Different examiners completed the clinical evaluations and measurements from the MRI imaging, and the MRIs, from which the measurements were taken, did not take place at the one center. | ||
| Longo et al. (46) |
|
Using a goniometer | Not performed | Each ROM was measured three times by both examiners | |
| Main | An arthroscopic single-row repair technique, with suture anchors:
|
||||
| Additional | An acromioplasty for acromion type III | ||||
CMS, Constant–Murley score; DASH, disabilities of the arm, shoulder, and hand; NR, not reported; ROM, range of motion; SSV, subjective shoulder value; VAS, Visual Analog Scale; WORC, Western Ontario rotator cuff index.
All studies assessed functional outcomes, but not all reported both ROM and patient-reported outcome measures (PROMs). ROM (forward flexion, abduction, external rotation, and internal rotation) were measured in three studies (41, 45, 46), but Longo et al. (46) only measured forward flexion and external rotation. Meanwhile, PROMs were examined by all of the studies (41, 42, 43, 44, 45, 46), but the CMS score was reported only in five studies (41, 42, 43, 44, 45) while the ASES score was in two studies (41, 43). The remaining PROMs, such as the University of California, Los Angeles (UCLA) shoulder score, Wolfgang criteria shoulder score, and Oxford shoulder score (OSS) determined by Longo et al. (46); subjective shoulder value (SSV) score and Western Ontario rotator cuff (WORC) index provided by Haneveld et al. (44); and disability of the arm, shoulder, and hand (DASH) and work-DASH scores reported by Milano et al. (42) were not considered in our review because the measurements were only provided by one study each.
In two studies (42, 46), radiological evaluation was not performed. A radiological assessment was conducted by MRI in the remaining four studies (43, 44, 45) to assess complications, while Kim et al. utilized both MRI and CT scan (41). The complications were evaluated by two independent investigators, except for one study (43), which involved a multicenter study where many radiologists and examiners assessed imaging and functional outcomes. Furthermore, only three studies (41, 42, 46) blinded their examiners and investigators. All these surgical techniques, rehabilitation procedures, and outcome evaluation procedures are elaborated in Table 2.
The BSA group used the same type of PLLA-based BSA in four studies (42, 44, 45, 46). Three studies utilized the Biocorkscrew 5.5 mm (Arthrex, Naples, FL, USA), and one study utilized the 4.5 mm Healix Advance BR (DePuy Mitek Inc., Raynham, MA, USA). The biocomposite suture anchors developed by Kim et al. (41) and Benedetto et al. (43) were composed of PLLA–hydroxyapatite and polylactic glycolic acid–β-TCP, respectively. Contrary to this, the NBSA group utilized PEEK material in four studies (41, 43, 44, 45) and titanium in two studies (42, 46). Kim et al. (41) assessed bone ingrowth ossification with an open-vented construction design in the NBSA group. In addition, Ro et al. (45) divided the patients into three groups (2 NBSA groups and 1 BSA group). The two groups used NBSA made of PEEK and UHMWPE (all-suture anchors), respectively. However, we did not include UHMWPE group from Ro et al.’s study in our review, as this group has a disproportional sample size (137 patients compared to 36 and 40 patients in PLLA and PEEK groups, respectively) that would lead to bias. Table 3 summarizes the types of suture anchors used in each group.
Suture anchor characteristics within studies.
| Study | BSA | NBSA | ||||
|---|---|---|---|---|---|---|
| Implant type | Dimensions* | Manufacturer details | Implant type | Dimensions* | Manufacturer details | |
| Kim et al. (41) | PLLA hydroxyapatite | NR | TWINFIX-HA (Smith & Nephew, Andover, MA, USA) | PEEK | NR | HEALICOIL (Smith & Nephew, Andover, MA, USA) |
| Milano et al. (42) | PLLA | 5.5 mm | Biocorkscrew FT, (Arthrex, Naples, FL, USA) | Titanium metallic suture | 5.5 mm | Corkscrew FT II (Arthrex, Naples, FL, USA) |
| Haneveld et al. (44) | PLLA | 5.5 mm | Biocorkscrew (Arthrex, Naples, FL, USA) | PEEK | 5.5 mm | Corkscrew FTII (Arthrex, Naples, FL, USA) |
| Ro et al. (45) | PLLA | 4.5 mm (three threads) x 15 | Healix Advance BR (DePuy Mitek, Raynham, MA, USA) | PEEK | 5.5 (three threads) x 16.5 | Helicoil PK (Smith & Nephew, Andover, MA, USA) |
| Benedetto et al. (43) | Polylac–tic glycolic acid–β- tricalcium phosphate | NR | NR | PEEK | NR | NR |
| Longo et al. (46) | PLLA | NR | Biocorkscrew (Arthrex, Naples, FL, USA) | Titanium metallic suture | NR | Corkscrew (Arthrex, Naples, FL, USA) |
*Diameter × Length
BSA, biodegradable suture anchor; NBSA, nonbiodegradable suture anchor; NR, not reported; PEEK, polyetheretherketone; PLLA, poly-l-lactic acid.
Risk of bias within individual studies
According to the study design, three reviewers used appropriate tools to assess the risk of bias within individual studies. Two RCT studies (41, 42) were assessed using RoB 2 (28) (Fig. 2A) and were deemed to have a low risk of bias. According to ROBINS-I (29) (Fig. 2A), four non-RCT studies have been evaluated, of which three (44, 45, 46) indicate a moderate level of bias, while one (43) indicates a high level of bias as a result of confounding and outcome measurement. Consequently, age differences between groups could affect functional outcomes due to degeneration and slower healing processes in older individuals (47). In addition, a large number of examiners and different centers performing outcome measurement without any standard guidelines or baseline can result in outcome measurement bias. The study by Benedetto et al. (43) indicated that the BSA group was younger than the NBSA group, which resulted in a significant confounding bias as a result of differences in baseline characteristics. Moreover, this study (43) defines type 3 Sugaya classification (48, 49) as a retear condition, although most of the literature suggested Sugaya type 3 not as a retear because no tendon discontinuity is found in type 3 (50, 51, 52, 53). This could lead to bias in outcome measurement (domain 6). Hence, our meta-analysis excluded this study due to its high risk of bias. However, we reclassified the retear based on Sugaya 1–3 classification to match the other studies.
Risk of bias assessment results by using (A) RoB 2 tool for RCT studies and (B) ROBINS-I tool for non-RCT studies.
Citation: EFORT Open Reviews 8, 10; 10.1530/EOR-23-0012
Qualitative synthesis
Our review assessed four primary outcomes: forward flexion, abduction, external rotation, and internal rotation. The ASES score, CMS, tendon healing assessment, PCF complication, retear, and other complications were defined as secondary outcomes. A summary of the findings is provided in Tables 4, 5, and 6.
Primary outcome of shoulder ROM and secondary outcome of CMS and ASES score within studies.
| Study | Follow-up (months) | Range of motion (degrees) | Constant–Murley score | ASES score | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Forward flexion | Abduction | External rotation | Internal rotation | |||||||||||
| BSA | NBSA | BSA | NBSA | BSA | NBSA | BSA | NBSA | BSA | NBSA | BSA | NBSA | BSA | NBSA | |
| Kim et al. (41) | 24.8 ± 3.5 | 25.6 ± 4.5 | 147.5 ± 4.9 | 147.7 ± 4.7 | 80.1 ± 11.9 | 81.9 ± 9.5 | 79.8 ± 13.1 | 80.0 ± 8.9 | 9.9 ± 2.3 | 10.1 ± 1.3 | 85.4 ± 8.6 | 88.0 ± 8.5 | 86.1 ± 12.3 | 89.2 ± 8.5 |
| Milano et al. (42) | 24.4 ± 2.6 | 24.4 ± 2.6 | NR | NR | NR | NR | NR | NR | NR | NR | 98.6 ± 14.3 | 104 ± 20.5 | NR | NR |
| Haneveld et al. (44) | 28.1 ± 10 | 27.9 ± 7.8 | NR | NR | NR | NR | NR | NR | NR | NR | 79.2 ± 13.7 | 76.3 ± 9 | NR | NR |
| Ro et al. (45) | 10.1 ± 3.2 | 9.8 ± 2.3 | 165.1 ± 10.7 | 164.1 ± 7.7 | 107.5 ± 10.5 | 106.5 ± 10.5 | 46.9 ± 15.5 | 48.9 ± 13.0 | L1 | T12 | 72.0 ± 5.3 | 72.3 ± 5.8 | NR | NR |
| Benedetto et al. (43) | 12 ± 0 | 12 ± 0 | NR | NR | NR | NR | NR | NR | NR | NR | 95 ± 4.2 | 94.64 ± 4.4 | 95.83 ± 4.3 | 96 ± 1.7 |
| Longo et al. (46) | 48.6 ± 24 | 48.6 ± 24 | 163.6 ± 26.9 | 163.5 ± 28.2 | NR | NR | 44.6 ± 16.3 | 46 ± 19.7 | NR | NR | NR | NR | NR | NR |
ASES, American Shoulder and Elbow Surgeons score; BSA, biodegradable suture anchor; CMS, Constant–Murley score; NBSA, nonbiodegradable suture anchor; NR, not reported; ROM, range of motion.
Tendon healing assessment within included studies.
| Study | BSA | NBSA |
|---|---|---|
| Kim et al. (41)* | 18 of 19 evaluated patients (50% of total patients) | 21 of 22 evaluated patients (63.6% of total patients) |
| Milano et al. (42) | NR | NR |
| Haneveld et al. (44) | 10 of 16 patients (62.5%) | 13 of 20 patients (65%) |
| Ro et al. (45) | 24 of 36 patients (66.7%) | 31 of 40 patients (77.5%) |
| Benedetto et al. (43)** | 18 of 18 patients (100%) | 15 of 15 patients (100%) |
| Longo et al. (46) | NR | NR |
*Only 19 patients (58%) in BSA group and 22 patients (61%) in NBSA group underwent rotator cuff integrity assessment by MRI or USG at 12 months postoperatively; **Healed tendon was originally defined as type 1–2 Sugaya classification by the authors, rather than type 1–3 (48, 49);
BSA, biodegradable suture anchor; NBSA, nonbiodegradable suture anchor; NR, not reported.
Complications.
| Study | Perianchor cyst formation† | Retear | Other complications | Authors’ conclusion | ||
|---|---|---|---|---|---|---|
| BSA | NBSA | BSA | NBSA | |||
| Kim et al. (41) | 4 of 19 patients | 5 of 22 patients | 1 of 19 evaluated patients* (3% of total patients) | 1 of 22 evaluated patients* (2.8% of total patients) | NR | The study found similar clinical outcomes regardless of suture anchor material or shape after complete rotator cuff repairs. At 6 months after arthroscopic rotator cuff repair, an open-construct PEEK anchor showed better bone ingrowth than a nonvented biocomposite anchor. |
| Milano et al. (42) | NR | NR | NR | NR | Postoperative imaging studies were not conducted, so there was no report on inflammatory reactions, osteolysis, anchor migration or breakage). | The results indicated that, at a short-term follow-up, there was no significant difference between arthroscopic repair of full- thickness rotator cuff tears with metal or biodegradable suture anchors for the three outcomes evaluated—DASH score, Work-DASH score, and Constant score—even though metal suture anchors improved DASH score. |
| Haneveld et al. (44) | 44 of 51 (86%) suture anchors | 63 of 74 (85%) suture anchors Osteolysis in one patient |
6 of 16 (37%) patients | 7 of 20 (35%) patients |
|
In this study, PLLA anchors did increase osseous reaction. However, PEEK anchors also led to tunnel widening and peri-implant fluid. It is unclear whether anchor material has any impact on clinical or radiological outcomes. When analysing osseous reaction, it is critical to consider other causes, such as mechanical stress, in addition to biodegradation. |
| Ro et al. (45) | 13 of 36 patients | 11 of 40 patients | 12 of 36 (33.3%) patients | 9 of 40 (22.5%) patients | NR | As a result of suture anchors, 10.8% of cases of arthroscopic rotator cuff repair developed peri anchor cysts. VAS and Constant scores, retear rates, and peri anchor bone reactions did not differ significantly among all-suture, bioabsorbable, and PEEK anchors. There was, however, an association between retear rates and peri anchor cystic reactions. |
| Benedetto et al. (43) | Osteolysis (grade 1, with a punctual fluid signal within the anchor area) in 12% patients but were not specified from which group. | 0 of 18 (0%) patients | 0 of 15 (0%) patients | NR | The suture anchor material and shape did not affect clinical results after complete rotator cuff repair. In terms of clinical-functional and imaging results, anchors made of polylactic glycolic acid, calcium sulfate, and β-tricalcium phosphate appear to have comparable results to PEEK anchors. Further studies are required to determine the advantages of each material. | |
| Longo et al. (46) | NR | NR | NR | NR | No patient experienced infection, vascular, or neurological complications. | After a mean follow-up of 4.05 ± 2 years there were no statistically significant differences between the clinical and functional outcomes of arthroscopic RCR using metallic or biodegradable suture anchors. Arthroscopic rotator cuff repair outcome was not affected by implant material (metal vs biodegradable). |
*Only 19 patients (58%) in BSA group and 22 patients (61%) in NBSA group underwent rotator cuff integrity assessment by MRI or USG at 12 months postoperatively; †Osteolysis or perianchor fluid collection.
BSA, biodegradable suture anchor; DASH, disabilities of the arm, shoulder, and hand; NBSA, nonbiodegradable suture anchor; NR, not reported; PEEK, polyetheretherketone; PLLA, poly-l-lactic acid; RCR, rotator cuff repair; VAS, Visual Analog Scale.
Quantitative synthesis (meta-analysis)
We analysed primary (Fig. 3) and secondary (Fig. 4) outcomes in the meta-analyses. In the meta-analysis of two studies (41, 45) addressing shoulder internal rotation as a primary outcome, only one study (41) reported the outcome in degrees, so we did not perform a meta-analysis for internal rotation. From three studies (41, 45, 46) that measured the primary outcome, only one study (45) did not indicate whether a standard goniometer was used. In addition, one study (41) employed a CT scan to assess PCF, while the other studies (43, 44, 45) used MRI to obtain PCF results. Additionally, magnet strengths varied between studies. One study (43) did not include magnet strength because they measured it across many centers, thereby constituting a potential bias source. The outcome of the study (43) with a high risk of bias is represented in the graph but was not included in all of the calculations because it would alter the effect estimate. We performed meta-analyses on CMS, ASES scores, tendon healing, PCF, and retear rates as secondary outcomes since they were reported by more than one study. As stated previously, we did not retrieve the UHMWPE group data from one study (45) because this group had a larger sample size compared to the BSA group. However, the PEEK group sample size resembled the BSA group, which was comparable to analyse.
Quantitative meta-analysis of the primary outcome (range of motion (ROM)): (A) forward flexion, (B) abduction, (C) external rotation.
Citation: EFORT Open Reviews 8, 10; 10.1530/EOR-23-0012
Quantitative meta-analysis of secondary outcomes: (A) Constant–Murley score (CMS); (B) American Shoulder and Elbow Surgeons (ASES) score; (C) tendon healing; (D) perianchor cyst formation (PCF); (E) retear complication.
Citation: EFORT Open Reviews 8, 10; 10.1530/EOR-23-0012
Primary outcome
The meta-analysis of forward flexion (Fig. 3A) shows that the RC tears patients repaired by BSA had similar forward flexion ROM compared to those who were repaired with NBSA (mean: 159.87 ± 20.54 vs 159.27 ± 19.87; MD: −0.03; 95% CI: −2.02,1.96; P = 0.97,; I 2 = 0%). Likewise, the abduction (Fig. 3A) and external rotation (Fig. 3A) meta-analyses also yielded comparable results (mean: 93.20 ± 17.74 vs 93.55 ± 15.85; MD: −0.42; 95% CI: −3.90, 3.05; P = 0.81; I 2 = 0% and mean: 54.32 ± 21.42 vs 56.72 ± 20.81; MD: −1.05; 95% CI: −4.59, 2.48; P = 0.56; I 2 = 0%, respectively). As the mean differences were very small and almost neglectable (≤1 degree), we can conclude that both BSA and NBSA resulted in comparable forward flexion, abduction, and external rotation. We did not perform Egger’s test because the included studies were less than ten (31).
Secondary outcome
In shoulder functional measurement using PROMs, the CMS (Fig. 4A) was found to yield comparable results between these two materials (mean: 86.96 ± 14.82 vs 88.42 ± 18.19; MD −1.06; 95% CI: −3.02,0.91; P = 0.29; I 2 = 13%), whereas the ASES score (Fig. 4B) could not be interpreted as it only contains one eligible study (41) and one ineligible study (43) due to high risk of bias. However, we still provide the forest plot without the high risk of bias study (43) calculated.
Furthermore, tendon healing investigation (Fig. 4C) showed that using BSA decreased tendon healing compared to NBSA, although the difference was insignificant (73.2% vs 79.3%, OR: 0.69; 95% CI: 0.32, 1.51; P = 0.35, I 2 = 0%). In terms of PCF (Fig. 4D), both materials resulted in almost equivalent PCF events (57.5% vs 58.1%, OR: 1.21; 95% CI: 0.64, 2.28; P = 0.56; I 2 = 0%). Meanwhile, retear rates (Fig. 4E) were slightly higher in BSA compared to NBSA, although no statistical difference was found (26.8% vs 20.7%, OR: 1.45; 95% CI: 0.66, 3.16; P = 0.35; I 2 = 0%). All in all, the use of BSA and NBSA resulted in comparable functional outcomes measured by CMS as well as PCF complications. BSA decreased tendon healing and resulted in more retear events, but the differences were insignificant.
Evidence quality assessment
Our GRADE approach (33, 34, 35) results indicated that the evidence quality was poor due to individual study bias and imprecision (small sample size), with the exception of the ASES score, which was extremely low due to the nonapplicable heterogeneity in the inconsistency domain (Table 7). It is possible that our estimate of effect would be affected by further research because of the low and very low quality of the evidence. However, we believe that we have developed the best available evidence at this point.
GRADE evidence quality assessment.
| Outcomes | Number of | GRADE assessment | LOE | |||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Patients | Studies | Suture anchors | Risk of bias | Inconsistency | Indirectness | Imprecision | Other consideration | Overall certainty of evidence | ||
| Forward flexion ROM | 253 | 3 | Seriousa | Not serious | Not serious | Seriousb | None | ⨁⨁◯◯ | Low | |
| Abduction ROM | 145 | 2 | Seriousa | Not serious | Not serious | Seriousb | None | ⨁⨁◯◯ | Low | |
| External rotation ROM | 253 | 3 | Seriousa | Not serious | Not serious | Seriousb | None | ⨁⨁◯◯ | Low | |
| Constant–Murley score | 282 | 5 | Seriousa | Not serious | Not serious | Seriousb | None | ⨁⨁◯◯ | Low | |
| ASES score | 102 | 2 | Seriousa | Seriousc | Not serious | Seriousb | None | ⨁◯◯◯ | Very low | |
| Tendon healing | 153 | 4 | Seriousa | Not serious | Not serious | Seriousb | None | ⨁⨁◯◯ | Low | |
| Perianchor cyst complication | 3 | 242 | Seriousa | Not serious | Not serious | Seriousb | None | ⨁⨁◯◯ | Low | |
| Retear complication | 153 | 4 | Seriousa | Not serious | Not serious | Seriousb | None | ⨁⨁◯◯ | Low | |
GRADE Working Group grades of evidence:
High certainty: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate certainty: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low certainty: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low certainty: We are very uncertain about the estimate.
aModerate risk of bias as assessed with ROBINS-I. bSample size is relatively small (<400). cHeterogeneity cannot be calculated.
Discussion
Patient and intervention characteristics
This study reviews the use of NBSA and BSA in arthroscopic RC repair. In this study, the goal is to assess whether these material analyses provide satisfactory clinical results and reduce the complication rate of the procedure. In this review, the majority of patients were elderly individuals over the age of 60, and the comparisons between groups were similar; however, in one study (43), the NBSA group was significantly younger than the BSA group. Age may be a confounding factor since the microvascular system of the tendons is compromised in the elderly, making degeneration, microtears, calcification, fibrovascular proliferation, and general injury more likely (47). There is also evidence of muscle atrophy and fat infiltration following RC tears. Fat and fibrous tissue infiltrate into the degenerate, atrophied muscles to repair them. Atrophy and fatty infiltration are inversely related to strength loss, so this reparative mechanism is unsatisfactory (47). In Zhao et al.’s systematic review and meta-analysis, they found a significant correlation between RC tears and age (54). These factors could influence the functional outcome.
Table 2 summarizes the various surgical arthroscopic techniques, rehabilitation programs, and numerous methods for measuring primary outcomes and detecting complications in all the studies. One concern that may arise is a mix of single- and double-row techniques in our present review. Although the double-row technique is considered superior in treating larger RC tears (55, 56), it is technically demanding (48). Moreover, the evidence regarding the comparison of single- vs double-row technique show controversies, as the statistical differences might not always be clinically relevant (57). A number of systematic reviews and RCTs involving large and massive tears comparing the two methods reported that both techniques yielded equivalent outcomes (58). In addition, our heterogeneity tests did not indicate any concerns as a result of this technique variation (Cochran Q test’s P > 0.1 and I 2 < 50%); hence, we believe our included studies were homogeneous, and our comparison was appropriately justified.
In contrast, the additional subacromial decompression and bursectomy reported by three studies (41, 42, 44) would influence our results since the other three did not clarify if this procedure was used. The repetitive translation of the RC under the acromion, particularly type II and type III, would transform the partial thickness tear into a full-thickness tear (47). These may produce a bias between studies that probably affect our estimate effect. To assess these variations, we closely observed the heterogeneity test performed in forest plots. In the Cochran Q test, P >0.1 and I 2 < 50% were found in all primary and secondary outcomes, suggesting that these variations might not be important and have a neglectable impact on our estimate effect (32). However, only ASES score outcomes could not be interpreted because only one study (41) was included in the meta-analysis. Moreover, Benedetto et al.’s study (43) has been excluded from all analyses due to several considerations, including the significant age gap between the groups, failure to report the surgical technique procedure and rehabilitation program, and a difference in outcome measurement.
In our review, different types of suture anchors were used. We noticed that Ro et al. (45) compared three types of suture anchor materials. We exclude the UHMWPE group from our review because there is a high discrepancy in sample size amongst the UHMWPE group (137 samples) and the other two groups, namely, the biodegradable and PEEK groups (36 and 40 samples, respectively). Furthermore, in comparison with other studies included in our review, the UHMWPE material was not utilized in the study. To prevent heterogeneity, we excluded the UHMWPE group from our review. Kim et al. (41) also used a different suture anchor design to observe bone ingrowth. Our review did not focus on that case. Therefore, we can ensure that our estimate did not change as a result of this construction, as demonstrated by the 0% result in I 2 heterogeneity test.
Primary outcome
Our meta-analysis showed that RC repair using BSA and NBSA resulted in comparable forward flexion and external rotation ROM (P = 0.97 and P = 0.56, respectively). Interestingly, three studies (41, 45, 46) achieved a normal ROM average similar to the healthy general population in forward flexion (average 161.5° for men and 158.5° for women) (59) as well as external rotation (55.9° for men and 59.7° for women) (59) despite the participants in our included studies being the elderlies. It was quite the opposite for abduction ROM, which was far from the average normal abduction ROM (150.6° for men and 148.7° for women) (59). However, this finding is not unduly surprising, as abduction is mostly altered in RC injury. As for internal rotation, only two studies evaluated this function, and only Kim et al. (41) reported it in degrees, while the other study (45) used anatomical landmarks (L1 & T12).
One of the characteristics of such biodegradable devices is that they provide initial strength, but during degradation, their mechanical properties gradually deteriorate. With suture anchors, improvement was comparable to that of transosseous tunnel fixation (60). Metallic suture anchors provide rigid fixation and good clinical outcomes over the long term (16). As a strong and lightweight material, titanium is widely used in orthopedic surgery. It forms a surface layer of calcium and phosphate, which links directly to the bone without evidence of this fibrous layer and forms bone–plate integration. This process showed minimal inflammatory responses (61). The pull-out strength of BSA is comparable to that of metallic anchors, while due to the biodegradability of BSA, it has a certain time window for healing. In some cases, biodegradable anchors can be absorbed too rapidly, which can culminate in anchors failing to fix, while very slow degradation rates result in incomplete bony replacement and foreign body reactions (62). NBSA made from PEEK materials also has strong mechanical properties resulting in stable fixation. However, the materials have poor osteointegration properties (63). According to available literature regarding BSA, either PLLA or biocomposite materials have problems with degradation rates and osteointegration, resulting in initial fixation loss, anchor migration, and incomplete burial of anchors within the bone, along with implant breakage due to brittle construction (19, 64). According to our review, however, we found that the BSA could achieve good shoulder ROM comparable to the NBSA when examining shoulder ROM. Our study found no evidence of heterogeneity that may influence effect size between NBSA (titanium and PEEK) and BSA (PLLA and biocomposite PLLA) (I 2 heterogeneity test 0% in primary outcome ROM).
Secondary outcome
Our findings in primary outcomes were confirmed using the CMS as a subjective and objective measurement based on the patient’s and clinician’s assessment. There was an insignificant difference between the NBSA’s CMS results and the BSA’s (P = 0.29). Despite the lower CMS of the BSA, the results were excellent (>70) (65). Moreover, there were no issues found that could affect our effect estimates (I 2 heterogeneity test, <50%). A high risk of bias in one study (43) prevented us from interpreting the ASES score results.
In the RC tears repair, PCF and osteolysis were the most challenging complications to control. These complications could lead to fixation loss, anchor migration, and decreased stability which would affect clinical outcome (66). Furthermore, high-grade PCF is associated with a larger retear size which would impact subsequent revision surgery. BSAs should provide minimal PCF to ensure usage continuity (67). In our review of three studies (41, 44, 45) reporting PCF, we found a lower PCF for the BSA compared to the NBSA, but the difference was not statistically significant (P = 0.56). The BSA materials are comparable to the NBSA in both short and long-term evaluation. Ro et al. (45) reported the shortest evaluation (±10 months) and Haneveld et al. (44) reported the longest evaluation (±28 months).
According to the literature, BSA provides several advantages, including simple revision surgery, clear postoperative radiological evaluation, increased biocompatibility, and no implant removal surgery (12). However, cost and degradation rates must be considered when using these materials. The absorption period should be slow enough to provide adequate mechanical fixation of soft tissues to the bone during physiologic healing and to prevent inflammatory reactions and cyst formation. The inflammatory response remains a consequence of their implantation: exposure of the copolymers to synovial fluid may cause a foreign-body reaction, leading to reactive synovitis with pain and stiffness, which do not benefit from the administration of nonsteroidal anti-inflammatory drugs (60). On the other hand, NBSA materials, particularly metallic materials, compromise postoperative imaging and complicate revision surgery. In spite of the fact that the PEEK material showed improvement over metallic materials, it still has poor osteointegration. These problems might be solved using biocomposite materials, but we should consider the cost and benefits of using them (12). Even though biocomposite material provides promising results with minimal complications, we should be aware of the high cost and that the same results can be achieved with NBSAs at a more reasonable cost. Based on our research, BSA was comparable to NBSA for both fixation and stabilization, as well as PCF formation, with the benefit of arguably less complicated revision surgery, better postoperative imaging, improved biocompatibility, and no need for removal.
Nevertheless, our study revealed that BSA caused more retear events and decreased tendon healing than NBSA, although no statistical differences were observed. Some BSA were reported to have rapid degradation that affects the initial strength and fixation. During the time tissue healing is expected, tendon retear could occur due to weaker fixation (owing to early degradation) and PCF formation. Rapid degradation leading to the release of monomers overwhelms the body’s ability to eliminate by-products. Hence, inflammatory reactions such as lytic changes, cyst formation, synovitis, allergic responses, and loose foreign bodies tend to occur (68). The new material development and surface modification strategies should concern the techniques and strategies on composite coatings to mimic human bone. Thus, newer generations of materials could improve implant integration as well as tendon and bone healing (13).
Agreement and disagreement with other studies
Based on the data presented in this review, BSA can produce comparable clinical outcomes and complications to NBSA. Our findings were in accordance with Tan et al. In their study comparing BSA and NBSA for treating Bankart lesions, they reported no differences in the outcomes of arthroscopic Bankart repair (23). Moreover, a study by Matijakovic et al., which specifically compared the UHMWPE and PLLA biocomposite suture anchors, revealed no significant difference in PCF incidence, with patients without PCF showing higher functional scores. Moreover, ROM and RC strength were similar between groups (40). With their study comparing BSA and NBSA in open shoulder stabilization for posttraumatic shoulder dislocations, Ejerhed et al. also reported equivalent results in terms of stability and functionality (69). With the recent update of RC tears repair using various suture anchor materials, our present review was conducted with thorough bias analysis, ensuring the robustness of our results.
Strength and limitations
We are limited to only six studies that were able to meet guideline criteria, to only two randomized controlled trials that were head-to-head comparisons of suture anchor materials, and to various follow-up times, surgical techniques, outcomes measurement, and rehabilitation procedures between the studies that may have led to potential bias. Moreover, from the six studies included, one study should not be included in the meta-analysis because of high bias risk. Because of the small number of studies included, we did not perform a meta-regression and Egger’s test to explore possible correlations with other risk factors, such as types of knots, number of anchors, and extent of tendon-to-bone healing. Our studies, however, used robust methodologies, including a thorough bias analysis and GRADE methodology, to validate the quality of our findings. Thus, we provided the most recent available evidence of direct comparative studies between BSA and NBSA in treating RC tears with arthroscopy surgery. Bioabsorbable anchors may produce inflammatory reactions, with reactive synovitis associated with pain and stiffness that do not respond to the use of anti-inflammatory drugs. Future studies should examine whether these variables affect clinical outcomes.
Conclusion
Our review showed that BSA had comparable functional outcomes (ROM and CMS) and caused similar PCF compared to NBSA. However, BSA decreased tendon healing and increased retear rates, although no statistical differences were observed.
Supplementary material s
This is linked to the online version of the paper at https://doi.org/10.1530/EOR-23-0012.
ICMJE conflict of interest statement
The authors declare that there is no conflict of interest that could be perceived as prejudicing the impartiality of the research reported.
Fundingstatement
This research did not receive any specific grant from any funding agency in the public, commercial, or not-for-profit sector.
Acknowledgements
We thank Ms. Evlyn Santoso for her administrative assistance. We thank the Indonesian Endowment Fund for Education (LPDP) for supporting Brigita De Vega with her PhD scholarship (202111220807913).
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