Bioinductive collagen scaffolds for partial- and full-thickness rotator cuff repair: a systematic review

Article information

Clin Shoulder Elb. 2026;29(3):416-424
Publication date (electronic) : 2026 September 1
doi : https://doi.org/10.5397/cise.2025.01326
1Glan Clwyd Hospital, Wales, UK
2Great Western Hospitals NHS Foundation Trust, Swindon, UK
Corresponding Author: Vaishnav Raghavan Satheesh Kumar Glan Clwyd Hospital, 5 Clos Beaumaris, Bodelwyddan, Rhyl, Denbighshire, Wales LL18 5UJ, UK Tel: ‪+44-7435-39-5820,‬ E-mail: vaishnavrs2k8@gmail.com
Received 2025 November 17; Revised 2026 July 3; Accepted 2026 July 19.

Abstract

Background

Partial-thickness rotator cuff tears (PTRCTs) are a common and challenging cause of shoulder pain and dysfunction. Bioinductive collagen scaffolds (BCS) have emerged as a biologic adjunct intended to mimic the extracellular matrix and promote tendon regeneration. The aim of this systematic review was to evaluate the reported clinical outcomes, imaging-based structural findings, safety, and follow-up outcomes of BCS in adults treated for partial-thickness and selected full-thickness rotator cuff tears.

Methods

A systematic search of Medline, ScienceDirect, and Google Scholar was performed for English-language studies published up to March 2024. The review followed Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 guidelines and was registered in PROSPERO. Eligible studies included adults with PTRCTs or selected full-thickness tears treated with BCS, either as an isolated intervention or as augmentation during repair. Extracted outcomes included patient-reported outcomes, imaging-based tendon healing, adverse events, and follow-up duration. Study quality was assessed using the Critical Appraisal Skills Programme (CASP) checklist.

Results

Of 161 records identified, four studies involving 315 participants met the inclusion criteria: one retrospective case series, one prospective single-arm study, one prospective follow-up study, and one prospective multicenter registry study. Included studies reported postoperative improvements in functional outcomes, including American Shoulder and Elbow Surgeons, Constant-Murley, and University of California, Los Angeles scores, with pain reduction. Magnetic resonance imaging and ultrasound findings suggested increased tendon thickness and favorable structural healing, with reported healing rates up to 96% within 12–24 months. No major adverse events, foreign-body reactions, or implant-related complications were reported. Heterogeneity precluded meta-analysis.

Conclusions

BCS may improve pain, function, and structural outcomes in selected rotator cuff tears; however, evidence remains limited, heterogeneous, and predominantly non-randomized.

INTRODUCTION

Partial-thickness rotator cuff tears (PTRCTs) are common in orthopedic practice and pose significant diagnostic and management challenges. PTRCTs involve only part of the rotator cuff tendon, ranging from fraying of the tendon fibers to full-thickness involvement of the articular surface. Although full-thickness tears have been extensively studied and treated, the optimal therapeutic strategy for PTRCTs remains under discussion [1]. These tears may occur within the tendon or on its articular or bursal surface, and their patterns vary among age groups. In younger athletes, tears tend to develop more posteriorly at the supraspinatus-infraspinatus interval, whereas in older patients, they typically occur on the articular side of the supraspinatus tendon near its attachment to the greater tuberosity [2]. Anatomic studies have provided insight into the dimensions of the supraspinatus tendon, with a reported mean anteroposterior dimension of 25 mm [3]. Ellman developed a classification system based on tear location and depth, categorizing tears as grade 1, 2, or 3 according to their depth relative to tendon thickness [4]. PTRCTs affect people of all ages and activity levels and contribute substantially to the overall burden of shoulder disease. Recent epidemiological studies have reported that the prevalence of shoulder pain and dysfunction ranges from 13% to 54% [5,6]. These tears, which cause pain, weakness, and functional limitations, frequently result from acute trauma, degenerative changes, or recurrent microtrauma. Moreover, PTRCTs have been associated with substantial reductions in productivity and quality of life, placing a considerable financial burden on healthcare systems [7]. Rotator cuff tears also impose substantial direct medical costs and indirect costs related to lost work and rehabilitation [8]. The burden of rotator cuff tears is expected to increase because of population aging and the rising prevalence of the condition, highlighting the need for effective management strategies [9,10]. Although several surgical procedures are used to repair rotator cuff tears, the optimal method remains uncertain because of high re-tear rates and suboptimal functional outcomes. Arthroscopic approaches to PTRCTs include acromioplasty, debridement with or without acromioplasty, transtendinous repair, and conversion to a full-thickness tear followed by repair. However, reported outcomes vary widely, making it difficult to determine the most effective approach [11,12]. Despite these challenges, bioinductive collagen scaffolds offer a potentially effective means of improving clinical outcomes. Bioinductive scaffolds are biocompatible materials designed to mimic the extracellular matrix (ECM), promote tissue regeneration, and provide structural support [13,14]. By promoting cellular infiltration, neovascularization, and collagen deposition, these scaffolds provide a novel approach to rotator cuff repair that may accelerate healing and reduce the risk of re-tear [15]. However, the evidence base for bioinductive collagen scaffolds remains limited and heterogeneous. Published studies vary substantially in tear type and size, surgical indication, concomitant procedures, imaging modality, definitions of tendon healing, outcome measures, and follow-up duration. In addition, most available studies involve small cohorts and are non-randomized or registry-based, limiting causal inferences regarding clinical effectiveness. Long-term data on the durability of tendon healing, re-tear prevention, implant-related complications, revision surgery, and cost-effectiveness are also sparse. Therefore, a systematic synthesis of the available clinical evidence is needed to clarify the reported outcomes, safety profile, methodological limitations, and evidence gaps associated with the use of bioinductive collagen scaffolds in partial-thickness and selected full-thickness rotator cuff tears.

This systematic review aimed to evaluate the reported clinical outcomes, imaging-based structural findings, safety, and follow-up outcomes of the use of bioinductive collagen scaffolds (BCS) in adult patients undergoing treatment for partial-thickness and selected full-thickness rotator cuff tears.

The specific objectives were as follows: (1) to summarize patient-reported clinical outcomes following BCS use in rotator cuff repair; (2) to describe imaging-based structural outcomes, including tendon thickness, defect filling, tendon continuity, and reported healing; (3) to evaluate reported safety outcomes, including adverse events, implant-related complications, inflammatory reactions, re-tears, and revision surgery; and (4) to identify methodological limitations, heterogeneity, and evidence gaps in the current literature.

METHODS

Eligibility Criteria and Information Sources

A systematic literature search was conducted in Medline/PubMed, ScienceDirect, and Google Scholar from database inception to March 2024. The review was conducted and reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 guidelines [16] and was prospectively registered in PROSPERO. Studies were considered for inclusion based on predefined eligibility criteria rather than free full-text availability. When full texts were not immediately accessible, attempts were made to obtain the articles through institutional subscriptions, interlibrary access, or direct contact with the corresponding authors. If the authors did not respond or the full text could not be retrieved after these attempts, the study was documented as not retrieved. Only English-language, full-text clinical studies with extractable outcomes were included. Two authors (VRSK and DN) independently conducted the primary and secondary screening, resolving disagreements by consensus or consultation with a third author (VV). During primary screening, VRSK and DN assessed titles and abstracts and removed duplicates. During secondary screening, both authors independently reviewed the full texts against the inclusion criteria and extracted the required information into a predesigned template. The two templates were checked for completeness and accuracy, and discrepancies were resolved by consensus. Ethical approval was not applicable because the data were obtained from publicly available sources.

Inclusion and Exclusion Criteria

(1) Population: adult patients aged ≥18 years with PTRCTs or selected full-thickness, large, or massive rotator cuff tears treated with a BCS, either as an isolated bioinductive procedure or as augmentation during rotator cuff repair, were included. (2) Exposure: the exposure of interest was treatment with a bioinductive collagen scaffold. (3) Outcomes: the primary outcomes of interest were the effectiveness, safety, and long-term outcomes of bioinductive collagen scaffolds. (4) Study design: we included all analytical studies (prospective, retrospective, and cross-sectional studies). We included studies of adults with PTRCTs, including both articular-sided and bursal-sided lesions, and larger cuff tears treated with bioinductive collagen implants, either as an isolated intervention or in conjunction with arthroscopic repair. Studies were required to use validated outcome scoring systems and have a minimum follow-up period of 12 months. Exclusion criteria were the absence of bioinductive collagen scaffold use for rotator cuff tears; lack of extractable clinical, imaging, histological, or safety outcomes; animal or cadaveric studies; biomechanical studies; technical notes without clinical outcomes; conference abstracts without sufficient data; and non-English articles. Small case series with fewer than 10 participants were generally excluded, except for biopsy-based clinical studies reporting unique histological or implant-related safety outcomes directly relevant to the review objectives. Studies were not excluded solely because they included full-thickness tears if they otherwise met the eligibility criteria and reported outcomes after bioinductive collagen scaffold augmentation.

Search Strategy

The search strategy combined terms related to the population, intervention, and procedure. Search terms included “rotator cuff,” “rotator cuff tear,” “partial-thickness rotator cuff tear,” “full-thickness rotator cuff tear,” “large rotator cuff tear,” “massive rotator cuff tear,” “bioinductive collagen scaffold,” “bio-inductive collagen scaffold,” “bioinductive implant,” “collagen implant,” “bovine collagen implant,” “rotator cuff repair,” and “arthroscopic rotator cuff repair.” Boolean operators were used to combine terms within and across concepts. Reference lists of included articles and relevant reviews were manually screened to identify additional eligible studies. Abstract-only publications, technical notes without clinical outcomes, animal or cadaveric studies, and studies without extractable clinical or imaging outcomes were excluded. The detailed database-specific search strategy is provided in Supplementary Material 1.

Search and Data Collection Process

The primary investigators (VRSK and DN) performed the data extraction. The extracted information included author details, publication year, study design, sample size, geographical location, inclusion criteria, range of PTRCTs and other tears, tear location and type, follow-up duration, type of bioinductive collagen scaffold used, mean age, and sex. Before conducting this review, PROSPERO and the Cochrane Library were searched for previous work on the same topic.

Data Extraction

Rotator cuff tears were categorized by location and depth using Ellman's classification system. Tear location was classified as articular surface (A), bursal surface (B), or interstitial (C). Tear depth was graded as less than 3 mm (I), 3 to 6 mm (II), or more than 6 mm (III), corresponding to more than 50% of the supraspinatus tendon width. Treatment strategies for partial-thickness tears and any additional procedures performed to address coexisting shoulder conditions were recorded. Clinical and patient-reported outcome measures were extracted from the studies, together with preoperative and postoperative data. These measures included the University of California, Los Angeles (UCLA) score, Constant-Murley score, American Shoulder and Elbow Surgeons score, Pennsylvania Shoulder Scale, Simple Shoulder Test, Japanese Orthopaedic Association score, L'Insalata score, Neer criteria, and visual analog scale for pain. When available, postoperative follow-up duration, imaging modalities, and the proportion of patients satisfied with their outcomes were also recorded.

Data Analysis

Data independently extracted by the two reviewers were collated in a standardized data-extraction spreadsheet. Results were summarized narratively according to tear type, study design, clinical outcomes, imaging findings, safety outcomes, and follow-up duration. Study quality was assessed using design-specific CASP checklists for observational studies and prospective trials [17]. Separate CASP checklists appropriate for the included study designs (cohort studies and case series) were used.

RESULTS

Study Selection

The systematic search identified 161 records, of which 113 duplicates were removed. After title and abstract screening, 7 articles remained for full-text review; 3 were excluded because they did not meet the inclusion criteria. The remaining 4 articles, involving a total of 315 participants, were included in the systematic review [18-21]. The PRISMA 2020 flow diagram is presented in Fig. 1, and the detailed search strategy is provided in Supplementary Material 1.

Fig. 1.

Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 flow diagram for new systematic reviews which included searches of databases, registers and other sources.

Characteristics of the Included Studies

Four observational clinical studies evaluating bioinductive collagen scaffold use in rotator cuff repair were included. Arnoczky et al. [20] conducted a retrospective case series involving patients who underwent collagen implant augmentation and subsequent second-look biopsy. Thon et al. [19] conducted a prospective single-arm study assessing safety and healing after scaffold augmentation for large and massive rotator cuff tears. Bokor et al. [18] conducted a prospective follow-up study evaluating magnetic resonance imaging (MRI) and clinical outcomes after bioinductive collagen scaffold use in partial-thickness supraspinatus tears. Bushnell et al. [21] conducted a prospective multicenter registry study evaluating clinical outcomes after treatment of PTRCTs with a resorbable bioinductive bovine collagen implant. Although Arnoczky et al. [20] included only seven participants, the study was retained because it provided unique biopsy-based histological evidence on scaffold integration and implant-related inflammatory responses that was unavailable from the other studies. Because all included studies were observational or single-arm, the overall level of evidence was limited, and no meta-analysis was performed. Table 1 presents the characteristics of the included studies and summarizes their risk of bias as assessed with the CASP checklist [18-21].

Characteristics of the included studies (n=4)

Because the included studies differed substantially in tear type and surgical indication, results were stratified descriptively rather than analyzed as a single homogeneous group. Bokor et al. [18] and Bushnell et al. [21] primarily evaluated patients with PTRCTs treated with a bioinductive collagen implant. Thon et al. [19] evaluated patients with large and massive full-thickness rotator cuff tears treated with scaffold augmentation, including both primary and revision repairs. Arnoczky et al. [20] was a retrospective biopsy-based case series of patients who underwent rotator cuff repair augmented with a collagen implant and subsequently underwent second-look surgery. Given these important differences in tear severity, surgical history, prognosis, and outcome assessment, the findings were not pooled. Instead, outcomes are presented narratively within the context of the tear type and study design from which they were derived.

Excluded Studies

Of the seven full-text articles assessed, three were excluded because they did not clearly define the inclusion criteria for PTRCTs. This systematic review examined the current evidence on bioinductive collagen scaffolds for rotator cuff repair, focusing on their effectiveness relative to traditional techniques, safety profile, and long-term outcomes.

Reported Clinical Outcomes

Because the included evidence was predominantly non-randomized and heterogeneous, the available data do not permit definitive conclusions regarding comparative effectiveness. Therefore, clinical outcomes are summarized as reported improvements within individual studies, and comparative interpretation is limited to studies that included a comparator group.

Pain and function

Bushnell et al. [21] reported significant improvements in pain and function scores, measured with the American Shoulder and Elbow Surgeons (ASES) score, Single Assessment Numeric Evaluation, and Western Ontario Rotator Cuff Index, at the one-year follow-up among patients receiving the collagen scaffold compared with a control group undergoing take-down and repair. Similarly, Bokor et al. [18] observed substantial improvements in Constant and ASES scores at 24 months, indicating reduced pain and improved function. Thon et al. [19] reported good to excellent ASES scores at the final follow-up (24 months), with a mean score of 82.87, indicating substantial functional recovery. This improvement was consistent across tear sizes and repair types (primary vs. revision). Arnoczky et al. [20] reported that four of the seven patients experienced a traumatic event that caused varying degrees of disruption to the repair construct. Three of these patients underwent revision repair with placement of a new implant over the original implant.

Tendon healing and MRI assessment

Imaging-based structural outcomes were reported using heterogeneous methods across the included studies. MRI was used in Bokor et al. [18] to assess changes in tendon thickness, defect size, and maturation of newly formed tissue, whereas Thon et al. [19] used both MRI and ultrasound to evaluate tendon continuity and postoperative tendon thickness. However, the studies did not apply a uniform definition of “healing,” and imaging protocols differed with respect to modality, timing of postoperative assessment, and the criteria used to define structural recovery. Therefore, imaging findings were synthesized descriptively rather than pooled quantitatively. In Bokor et al. [18], MRI demonstrated induction of new tissue over the bursal surface of the supraspinatus tendon, with increased tendon thickness and progressive filling of the partial-thickness defect during follow-up. Complete disappearance of the tear was reported in a proportion of patients in whom preoperative and postoperative tear size could be compared. In Thon et al. [19], postoperative MRI and ultrasound demonstrated tendon continuity in most patients, with a reported healing rate of 96% at final follow-up. However, because this study included large and massive tears and used different structural endpoints from studies of partial-thickness tears, these findings should not be interpreted as directly comparable across tear categories.

Overall, the available imaging evidence suggests that BCS may be associated with increased tendon thickness, defect filling, and maintenance of tendon continuity in selected patients. Nevertheless, the lack of standardized imaging protocols and uniform healing definitions limits the certainty of conclusions regarding structural tendon healing.

Ultrasound assessment

Thon et al. [19] found no significant difference in final rotator cuff thickness on ultrasound between primary and revision cases (7.18 mm vs. 7.43 mm, respectively; P=0.82) or between large and massive tears (7.78 mm vs. 7.03 mm, respectively; P=0.20).

Safety

According to Thon et al. [19], healing was successful in 96% of cases assessed by ultrasound and MRI (22 out of 23). Thus, 22 of the 23 patients had a healed rotator cuff tear. Final ASES scores ranged from 53.33 to 100, with a mean of 82.87 (standard deviation [SD], 16.68). The mean (SD) final ASES scores were 86.39 (14.20) for primary repairs and 82.22 (21.34) for revision repairs. The reported comparisons between these groups were not significant (P=0.69 and P=0.92). The safety profile of bioinductive collagen scaffolds appears favorable, and no major safety concerns were reported in any of the four studies included in this review.

Long-term outcomes

The included studies had follow-up durations ranging from 12 to 24 months. Studies with longer follow-up periods (Bokor et al. [18],Thon et al. [19]) reported sustained improvements in patient-reported outcomes (PROs) and high rates of tendon healing at 2 years. However, definitive conclusions about long-term durability and functional outcomes remain difficult because of the limited follow-up duration.

Risk of Bias in the Included Studies

Overall, risk-of-bias assessment demonstrated moderate methodological quality across included studies. Common strengths included clearly defined study aims, appropriate outcome measures, and consistent reporting of surgical techniques. However, limitations were frequently noted in relation to small sample sizes, absence of comparator groups, lack of blinding, and relatively short follow-up durations, reflecting the early-stage clinical evaluation of this intervention.

DISCUSSION

This systematic review identified four clinical studies including 315 participants who underwent treatment with BCS for partial-thickness or selected full-thickness rotator cuff tears. Overall, the included studies reported improvements in PROs, pain scores, and imaging-based structural parameters after scaffold use. However, these findings must be interpreted cautiously because the evidence base is small, clinically heterogeneous, and predominantly non-randomized. Tear type, tear size, surgical context, imaging modality, and follow-up duration varied substantially across studies, and most studies lacked a concurrent control group. Therefore, the current evidence supports only preliminary conclusions regarding feasibility, safety, and potential clinical benefit, rather than definitive conclusions regarding superiority over conventional repair.

Evaluating the effectiveness and potential benefits of bioinductive collagen scaffolds for rotator cuff repair requires comparison with conventional methods. However, the present review did not formally compare bioinductive collagen scaffolds with autografts, allografts, xenografts, synthetic grafts, or non-augmented repair in randomized comparative studies. Therefore, references to other graft types should be interpreted only as background context. The findings of this review are limited to the clinical and imaging outcomes reported in the four included studies evaluating bioinductive collagen scaffold use in partial-thickness and selected full-thickness rotator cuff tears.

PROs, including pain relief, functional improvement, and satisfaction with surgery, are important measures of treatment success. Bokor et al. [18], Thon et al. [19], and Bushnell et al. [21] evaluated PROs after rotator cuff repair with bioinductive collagen scaffolds. Bokor et al. [18] and Thon et al. [19] reported improvements in function and pain after collagen scaffold surgery. In both studies, Constant and ASES scores improved significantly from preoperative values, indicating better shoulder function and pain relief. Objective evaluation of tendon healing provides important information about the long-term durability and structural integrity of rotator cuff repair. Using MRI to assess tendon thickness and defect size, Bushnell et al. [21] observed increased tendon thickness and gradual filling of defects one year after treatment with collagen scaffolds. These findings suggest that collagen scaffolds may promote tendon healing and regeneration. The observed improvements in tendon integrity and healing provide further support for their potential role in tissue repair.

Bioinductive collagen scaffolds are designed to enhance tissue regeneration and functional recovery after rotator cuff repair. They provide an ECM-like environment that supports cellular adhesion, migration, proliferation, and differentiation. By mimicking the structure and composition of the native ECM, collagen scaffolds facilitate the cellular activity required for tissue regeneration [22]. Collagen, the main component of these scaffolds, provides a structural foundation for cell adhesion and proliferation. Its fibrous architecture provides mechanical stability and promotes tissue ingrowth and cellular infiltration, resembling the organization of native tendon tissue. Collagen scaffolds can also incorporate ECM-related components, such as growth factors and glycosaminoglycans, to enhance their regenerative capacity [23]. Bioactive components within the scaffold trigger cellular responses required for tendon repair. Growth factors, including insulin-like growth factor, platelet-derived growth factor, and transforming growth factor-beta, regulate matrix formation, tissue remodeling, and cell proliferation. After implantation, these growth factors stimulate local cells and attract circulating progenitor cells to the injury site. Fibroblasts, tenocytes, and mesenchymal stem cells are stimulated to proliferate and differentiate into tendon-specific lineages, promoting collagen deposition, matrix organization, and tissue regeneration. Angiogenesis is essential to tissue repair because new blood vessels supply the oxygen and nutrients required for cell survival and matrix synthesis [24]. The porous scaffold facilitates endothelial cell migration and capillary development, promoting formation of a functional vascular network at the repair site. Scaffold resorption occurs through cellular phagocytosis and degradation by matrix metalloproteinases, while concurrent matrix deposition by fibroblasts and tenocytes promotes tissue development and integration [25].

Cost-Effectiveness and Patient Selection

The financial implications of BCS use are clinically important. These implants add cost to rotator cuff procedures, and the current evidence base does not yet establish whether the additional expenditure is offset by lower re-tear rates, reduced revision surgery, faster recovery, improved return to work, or better long-term function. Therefore, routine use in all rotator cuff tears cannot be recommended based on the available evidence. At present, the most rational use may be in carefully selected patients in whom biologic augmentation is expected to add value, such as patients with symptomatic high-grade partial-thickness tears, poor tendon quality, degenerative tears at risk of progression, revision repair settings, or large/massive tears where healing potential is compromised. However, these indications remain hypothesis-generating rather than definitive. Future studies should include formal cost-effectiveness analyses, stratified clinical outcomes, revision rates, return-to-work data, and health-related quality-of-life measures to determine which patient subgroups derive sufficient clinical benefit to justify the additional implant cost.

The available evidence supports the following cautious clinical interpretations. (1) BCS may be a feasible biologic adjunct in selected patients with partial-thickness and full-thickness rotator cuff tears. (2) Available studies report improvements in pain and shoulder function after scaffold use, but the lack of robust comparative trials prevents definitive attribution of these improvements to the implant itself. (3) Imaging findings suggest increased tendon thickness, defect filling, and maintenance of tendon continuity in some cohorts; however, imaging definitions and protocols were not standardized. (4) Reported safety outcomes were generally favorable, with no consistent signal of major implant-related complications, but the limited sample size restricts detection of uncommon adverse events. (5) Patient selection and cost-effectiveness remain unresolved and should be prioritized in future comparative studies.

CONCLUSIONS

In conclusion, the available evidence suggests that BCS may be associated with improved PROs, pain reduction, increased tendon thickness, and favorable imaging-based structural findings in selected patients undergoing treatment for partial-thickness and full-thickness rotator cuff tears. However, these findings should be interpreted cautiously because the evidence base is limited to a small number of heterogeneous studies, most of which are non-randomized and lack long-term comparative follow-up. The current evidence does not establish definitive superiority over standard rotator cuff repair techniques. Future adequately powered randomized or prospective comparative studies with standardized tear classification, imaging protocols, healing definitions, longer follow-up, and economic evaluation are required before broad recommendations regarding routine use can be made.

This systematic review provides a comprehensive evaluation of the current literature on bioinductive collagen scaffolds for rotator cuff repair, offering insight into their effectiveness and safety. The inclusion of studies with diverse methodologies broadens the evidence considered but reduces the generalizability of the findings. Because of substantial heterogeneity in study design, patient populations, and follow-up duration, quantitative pooling was not performed, and the data were reported descriptively. Additional strengths include the broad database search and the use of the CASP checklist and risk-of-bias tools to assess study quality. However, this review has several limitations. First, only four studies were eligible, and the total sample size was limited. Second, the included studies were heterogeneous in tear type and size, surgical indication, concomitant procedures, study design, imaging modality, outcome measures, and follow-up duration. Third, most included studies were non-randomized and lacked concurrent control groups, limiting causal inferences about the independent effect of the scaffold. Fourth, imaging-based outcomes were difficult to synthesize because definitions of healing, tendon continuity, defect filling, and tendon thickness were not standardized. Fifth, available follow-up was largely short to mid-term, limiting conclusions about durability, re-tear prevention, and revision surgery. Finally, cost-effectiveness could not be evaluated because the included studies did not report formal economic analyses. For these reasons, the results should be considered preliminary and hypothesis-generating.

Notes

Author contributions

Conceptualization: VRSK, VV, DN, JG. Data curation: VRSK. Formal analysis: VRSK. Investigation: VRSK, VV, DN, JG. Methodology: VRSK, VV, JG. Project administration: JG. Resources: VRSK, VV, DN, JG. Supervision: VRSK, VV. Validation: VRSK, DN. Visualization: DN. Writing – original draft: VRSK, VV. Writing – review & editing: VRSK, DN, JG. All authors read and agreed to the published version of the manuscript.

Conflict of interest

None.

Funding

None.

Data availability

Contact the corresponding author for data availability.

Acknowledgments

None.

SUPPLEMENTARY MATERIALS

Supplementary materials can be found via https://doi.org/10.5397/cise.2025.01326.

Supplementary Material 1.

Search strategy

cise-2025-01326-Supplementary-Material-1.pdf

References

1. Fukuda H. Partial-thickness rotator cuff tears: a modern view on Codman's classic. J Shoulder Elbow Surg 2000;9:163–8. 10.1067/mse.2000.101959. 10810700.
2. Milgrom C, Schaffler M, Gilbert S, van Holsbeeck M. Rotator-cuff changes in asymptomatic adults: the effect of age, hand dominance and gender. J Bone Joint Surg Br 1995;77:296–8. 10.1302/0301-620x.77b2.7706351. 7706351.
3. Sher JS, Uribe JW, Posada A, Murphy BJ, Zlatkin MB. Abnormal findings on magnetic resonance images of asymptomatic shoulders. J Bone Joint Surg Am 1995;77:10–5. 10.2106/00004623-199501000-00002. 7822341.
4. Waldt S, Bruegel M, Mueller D, et al. Rotator cuff tears: assessment with MR arthrography in 275 patients with arthroscopic correlation. Eur Radiol 2007;17:491–8. 10.1007/s00330-006-0370-7. 16969638.
5. Lucas J, van Doorn P, Hegedus E, Lewis J, van der Windt D. A systematic review of the global prevalence and incidence of shoulder pain. BMC Musculoskelet Disord 2022;23:1073. 10.1186/s12891-022-05973-8. 36476476.
6. Luime JJ, Koes BW, Hendriksen IJ, et al. Prevalence and incidence of shoulder pain in the general population; a systematic review. Scand J Rheumatol 2004;33:73–81. 10.1080/03009740310004667. 15163107.
7. Ardeljan A, Palmer J, Drawbert H, Ardeljan A, Vakharia RM, Roche MW. Partial thickness rotator cuff tears: patient demographics and surgical trends within a large insurance database. J Orthop 2019;17:158–61. 10.1016/j.jor.2019.08.027. 31879497.
8. Mather RC, Koenig L, Acevedo D, et al. The societal and economic value of rotator cuff repair. J Bone Joint Surg Am 2013;95:1993–2000. 10.2106/jbjs.l.01495. 24257656.
9. Finnan RP, Crosby LA. Partial-thickness rotator cuff tears. J Shoulder Elbow Surg 2010;19:609–16. 10.1016/j.jse.2009.10.017. 20171904.
10. Mall NA, Kim HM, Keener JD, et al. Symptomatic progression of asymptomatic rotator cuff tears: a prospective study of clinical and sonographic variables. J Bone Joint Surg Am 2010;92:2623–33. 10.2106/JBJS.I.00506. 21084574.
11. Strauss EJ, Salata MJ, Kercher J, et al. The arthroscopic management of partial-thickness rotator cuff tears: a systematic review of the literature. Arthroscopy 2011;27:568–80. 10.1016/j.arthro.2010.09.019. 21296545.
12. Yamanaka K, Matsumoto T. The joint side tear of the rotator cuff: a followup study by arthrography. Clin Orthop Relat Res 1994;304:68–73. 10.1097/00003086-199407000-00012.
13. Yamaguchi K, Tetro AM, Blam O, Evanoff BA, Teefey SA, Middleton WD. Natural history of asymptomatic rotator cuff tears: a longitudinal analysis of asymptomatic tears detected sonographically. J Shoulder Elbow Surg 2001;10:199–203. 10.1067/mse.2001.113086.
14. Chan BP, Leong KW. Scaffolding in tissue engineering: general approaches and tissue-specific considerations. Eur Spine J 2008;17 Suppl 4:467–79. 10.1007/s00586-008-0745-3. 19005702.
15. Randelli P, Randelli F, Ragone V, et al. Regenerative medicine in rotator cuff injuries. Biomed Res Int 2014;2014:129515. 10.1155/2014/129515. 25184132.
16. Page MJ, McKenzie JE, Bossuyt PM, et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ 2021;372:n71. 10.1136/bmj.n71. 33782057.
17. Zeng X, Zhang Y, Kwong JS, et al. The methodological quality assessment tools for preclinical and clinical studies, systematic review and meta-analysis, and clinical practice guideline: a systematic review. J Evid Based Med 2015;8:2–10. 10.1111/jebm.12141. 25594108.
18. Bokor DJ, Sonnabend D, Deady L, et al. Evidence of healing of partial-thickness rotator cuff tears following arthroscopic augmentation with a collagen implant: a 2-year MRI follow-up. Muscles Ligaments Tendons J 2016;6:16–25. 10.32098/mltj.01.2016.03. 27331028.
19. Thon SG, O'Malley L, O'Brien MJ, Savoie FH. Evaluation of healing rates and safety with a bioinductive collagen patch for large and massive rotator cuff tears: 2-year safety and clinical outcomes. Am J Sports Med 2019;47:1901–8. 10.1177/0363546519850795. 31150274.
20. Arnoczky SP, Bishai SK, Schofield B, et al. Histologic evaluation of biopsy specimens obtained after rotator cuff repair augmented with a highly porous collagen implant. Arthroscopy 2017;33:278–83. 10.1016/j.arthro.2016.06.047. 27650821.
21. Bushnell BD, Bishai SK, Krupp RJ, et al. Treatment of partial-thickness rotator cuff tears with a resorbable bioinductive bovine collagen implant: 1-year results from a prospective multicenter registry. Orthop J Sports Med 2021;9:23259671211027850. 10.1177/23259671211027850. 34409115.
22. Bailey JR, Kim C, Alentorn-Geli E, et al. Rotator cuff matrix augmentation and interposition: a systematic review and meta-analysis. Am J Sports Med 2019;47:1496–506. 10.1177/0363546518774762. 29906191.
23. Ahmad S, Haber M, Bokor DJ. The influence of intraoperative factors and postoperative rehabilitation compliance on the integrity of the rotator cuff after arthroscopic repair. J Shoulder Elbow Surg 2015;24:229–35. 10.1016/j.jse.2014.06.050. 25240808.
24. Nada AN, Debnath UK, Robinson DA, Jordan C. Treatment of massive rotator-cuff tears with a polyester ligament (Dacron) augmentation: clinical outcome. J Bone Joint Surg Br 2010;92:1397–402. 10.1302/0301-620X.92B10.24299. 20884978.
25. Sugaya H, Maeda K, Matsuki K, Moriishi J. Repair integrity and functional outcome after arthroscopic double-row rotator cuff repair: a prospective outcome study. J Bone Joint Surg Am 2007;89:953–60. 10.2106/JBJS.F.00512. 17473131.

Article information Continued

Fig. 1.

Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 flow diagram for new systematic reviews which included searches of databases, registers and other sources.

Table 1.

Characteristics of the included studies (n=4)

Study Country Sample size (male: female) Study design Study setting Inclusion and exclusion criteria Age (yr) Location of implant Procedure/ type of collagen used Outcome Quality of study (CASP checklist)
Arnoczky et al. (2017) [20] USA 7 (2:5) Retrospective case series Laboratory for Comparative Orthopaedic Research, College of Veterinary Medicine, Michigan State University, USA Inclusion: patients who underwent rotator cuff procedures using a collagen implant, followed by a second surgery with biopsy, over a 14-month period Mean±SD, 44.7±13.5 Anterior/anterolateral and posterolateral Rotator cuff tear augmented with a highly porous, highly aligned, reconstituted bovine collagen implant Pain, repair disruption, second-look arthros­copy, inflammation or foreign body reaction 7/12
Thon et al. (2019) [19] USA 23 (15:8) Prospective single-arm study Single site under a common protocol as a proof-of-principle study to assess the safety and healing rates of using a bioinductive collagen patch for large and massive rotator cuff tears Inclusion: any patient aged ≥30 years who underwent repair of a large or massive rotator cuff tear with the addition of the collagen scaffold implant 57.9 (range, 32–71) Not provided All patients who met the inclusion criteria were offered augmentation of their repairs with the patch and elected to undergo the procedure. Every patient had undergone extensive prior treatment that included physical therapy, injections, and/or anti-inflammatory medication for a minimum of 6 weeks before surgical intervention Safety outcomes such as worsening or permanent impairment, implant loosening, allergic reaction, adverse events, or death. Other outcomes included tendon thickness at each US examination, ASES scores, change in tendon thickness on US, tendon thickness on MRI, MRI confirmation of tendon continuity 8/12
Bokor et al. (2016) [18] USA 13 (8:5) Prospective follow-up study Not provided Inclusion: patients with chronic shoulder pain with partial-thickness tears of the supraspinatus tendon lasting longer than 3 months (resistant to analgesics, anti-inflammatory medication, and physical therapy) and patient age 40–67 years old at surgery 53.8 (range, 42–67) Bursal surface of the supraspinatus tendon The reconstituted collagen scaffolds were made from highly-purified, type I collagen from bovine tendons using proprietary methods MRI assessment of the size of the cuff defects, ASES score measured at 3, 6, 12, and 24 months postoperatively 6/12
Bushnell et al. (2021) [21] USA 272 (146:126) Prospective multicenter registry study Patients were enrolled between Apr 2016 and Dec 2018 at 19 centers across the United States Inclusion: patients more than 21 years, with partial-thickness tears of the rotator cuff Mean±SD, 52.1±10.0 Supraspinatus tendon and subacromial space A bioinductive implant made from highly purified reconstituted collagen fibers derived from bovine tendon and designed to completely resorb within 6 months Clinical recovery, ASES scores–shoulder function, pain and shoulder score, VR-12 scores and revision surgery. 7/12

CASP: Critical Appraisal Skills Programme, SD: standard deviation. US: ultrasound. ASES: American Shoulder and Elbow Surgeons. MRI: magnetic resonance imaging. VR-12: Veterans RAND 12-Item Health Survey.