A prospective, multicenter study to evaluate clinical and radiographic outcomes in primary rotator cuff repair reinforced with a xenograft dermal matrix

Lederman, Evan; Toth, Alison P.; Nicholson, Gregory P.; Nowinski, Robert J.; Bal, George K.; Williams, Gerald R.; Iannotti, Joseph P.

doi:10.1016/j.jse.2016.02.029

Cited by 34 publications

(16 citation statements)

References 28 publications

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“…The greater or lesser suitability of a scaffold to a particular treatment has been reflected in other studies showing the success of small intestine submucosa (SIS) augmentation in the repair of the Achilles and infraspinatus tendons, and its failure to repair massive chronic rotator cuff tears [20]. Recently, a prospective study demonstrated the benefits, in terms of better functional outcomes and structural reinforcement, of other xenograft membranes [24]. which highlights the relevance of bioscaffold choice in different musculoskeletal applications.…”

Section: Discussionmentioning

confidence: 99%

Adverse effects of xenogenic scaffolding in the context of a randomized double-blind placebo-controlled study for repairing full-thickness rotator cuff tears

Lamas

García-Fernández

Tornero-Esteban

et al. 2019

Trials

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Purpose The purpose of the study was to compare the safety and efficacy of autologous mesenchymal stem cells (MSCs) embedded in a xenogenic scaffold for repairing the supraspinatus tendon. Methods This was a randomized, double-blind and placebo-controlled trial evaluating patients with full-thickness rotator cuff tears (Eudra-CT, 2007–007630-19). Effectiveness was evaluated using the Constant score and a visual analogue pain scale (VAS). Constant score has four domains including pain (15 possible points), activities of daily living (20 possible points), mobility (40 possible points), and strength (25 possible points). Scores range from 0 points (most disability) to 100 points (least disability). The structural integrity of the repaired tendon was assessed by magnetic resonance imaging (MRI) according to Patte and Thomazeau classification criteria. The primary study end point was an improvement in the Constant score by 20 points at one year compared to initial assessment. Results The trial was stopped due to adverse effects observed in both groups. Only thirteen patients were included and analyzed. The Constant questionnaire showed a significant improvement in the MSC treatment group compared with the preoperative data (p = 0.0073). Secondary outcome measures were similar in both groups. Conclusions Our study showed preliminary inconclusive clinical outcomes in the patients treated with MSCs. Adverse events revealed the need for further approaches using scaffolds of a different nature or perhaps no scaffolds, in the context of small joints. Trial registration Eudra-CT, 2007-007630-19 . Registered on 30 January 2008. Level of evidence A Level 1 of evidence treatment study. Electronic supplementary material The online version of this article (10.1186/s13063-019-3504-3) contains supplementary material, which is available to authorized users.

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Section: Discussionmentioning

confidence: 99%

Adverse effects of xenogenic scaffolding in the context of a randomized double-blind placebo-controlled study for repairing full-thickness rotator cuff tears

Lamas

García-Fernández

Tornero-Esteban

et al. 2019

Trials

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“…For severely degenerated rotator cuff tears, patch augmentation is one potential surgical option to prevent postoperative rotator cuff retear. However, several studies investigating cuff integrity after rotator cuff repair with patch augmentation found that the retear rate is relatively high (10%-62%), 6,9,20,22,36,40 and some reports showed no improvement of postoperative cuff integrity after patch augmentation as compared with rotator cuff repair alone. 6,36 Flury et al 6 concluded that repairing supraspinatus tears with patch augmentation does not benefit patients in terms of reducing the risk of a recurrent tendon defect or improving shoulder function within 24 months after surgical repair.…”

Section: Discussionmentioning

confidence: 99%

Superior Capsule Reconstruction for Reinforcement of Arthroscopic Rotator Cuff Repair Improves Cuff Integrity

et al. 2018

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Background: Retear of repaired rotator cuff tendons worsens patient outcome and decreases patient satisfaction. Superior capsule reconstruction (SCR) was developed to center the humeral head and thus restore the force couple for patients with rotator cuff tears. Purpose: To evaluate whether SCR for reinforcement before arthroscopic rotator cuff repair (ARCR) improves cuff integrity. Study Design: Cohort study; Level of evidence, 3. Methods: Thirty-four consecutive patients (mean age, 69.1 years) with severely degenerated but reparable rotator cuff tears underwent SCR with fascia lata autografts for reinforcement before ARCR. All tears were medium (1-3 cm) or large (3-5 cm), and the number of torn tendons was 2 (supraspinatus and infraspinatus) in 29 shoulders and 3 (supraspinatus, infraspinatus, subscapularis) in 5 shoulders. To assess the benefit of SCR for reinforcement, all data were compared with those after ARCR alone among 91 consecutive patients with medium or large rotator cuff tears (mean age, 63.6 years). The American Shoulder and Elbow Surgeons (ASES) and Japanese Orthopaedic Association (JOA) scores, active shoulder range of motion, and cuff integrity (Sugaya magnetic resonance imaging classification) were compared ( t test and chi-square test) between ARCR with and without SCR, as well as before surgery and at final follow-up. Results: All 34 patients who underwent SCR before ARCR had neither postoperative retear nor type III cuff integrity, whereas those treated with ARCR alone had a 4% incidence (4 of 91) of retear and 8% incidence of type III cuff integrity. ASES and JOA scores, active elevation, active external rotation, and active internal rotation increased in both treatment groups ( P < .001). Postoperative ASES score and active range of motion did not differ between groups, although the Goutallier grade of the supraspinatus was higher for ARCR with SCR (mean, 2.8) than ARCR alone (mean, 2.1; P < .0001). Conclusion: SCR for reinforcement prevented retear at 1 year after ARCR and improved the quality of the repaired tendon on magnetic resonance imaging. Functional outcomes were similar between groups, even though degeneration of the torn tendons was greater among patients who underwent ARCR with SCR.

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“…The consistency and strength of synthetic ECMs indicate they are potential candidate augmentation materials that can allow cellular and fibrotic growth of rotator cuff repairs. Studies have shown significantly improved function and intact rotator cuff repairs that were augmented with synthetic ECM grafts [ 13 , 39 ]. One study reported retearing rates at follow-up 1 year after repair of 17%, 51%, and 41% in patients with synthetic graft augmentation, xenograft augmentation, and no augmentation, respectively [ 14 , 40 ].…”

Section: Surgical Treatment Optionsmentioning

confidence: 99%

Current Concepts and Recent Trends in Arthroscopic Treatment of Large to Massive Rotator Cuff Tears: A Review

Rho

Kwon

Choi

2019

Clin Shoulder Elbow

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Rotator cuff tear is a common cause of shoulder pain and disability in adults. Due to the various nature of progression of rotator cuff tears and the complex biomechanics of the shoulder joint, repair and treatment of large-to-massive tears are challenging for many surgeons. Despite the recent popularity of reverse total shoulder arthroplasty as a treatment option for large-to-massive irreparable rotator cuff tears, biological and mechanical repair augmentation has also shown promise as a viable treatment option. The purpose of this study was to briefly summarize and review current studies on the assessment and arthroscopic treatment of large-to-massive rotator cuff tears, whether repairable or irreparable, to aid in developing a consensus on future treatment directions.

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A prospective, multicenter study to evaluate clinical and radiographic outcomes in primary rotator cuff repair reinforced with a xenograft dermal matrix

Cited by 34 publications

References 28 publications

Adverse effects of xenogenic scaffolding in the context of a randomized double-blind placebo-controlled study for repairing full-thickness rotator cuff tears

Adverse effects of xenogenic scaffolding in the context of a randomized double-blind placebo-controlled study for repairing full-thickness rotator cuff tears

Superior Capsule Reconstruction for Reinforcement of Arthroscopic Rotator Cuff Repair Improves Cuff Integrity

Current Concepts and Recent Trends in Arthroscopic Treatment of Large to Massive Rotator Cuff Tears: A Review

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