Retear rates and clinical outcomes at 1 year after repair of full-thickness rotator cuff tears augmented with a bioinductive collagen implant: a prospective multicenter study

Bushnell, Brandon D.; Connor, Patrick M.; Harris, Howard W.; Ho, Charles P.; Trenhaile, Scott W.; Abrams, Jeffrey S.

doi:10.1016/j.jseint.2020.10.020

Cited by 21 publications

(12 citation statements)

References 51 publications

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Section: Discussionmentioning

confidence: 99%

“…22 Most recently, a 2020 publication of interim results from a prospective multicenter study of 115 patients with full-thickness rotator cuff tears receiving this implant as adjunctive to single-or double-row repair reported favorable retear rates and improved clinical function at 1 year. 23 Although these studies have advanced the understanding of this implant as an adjunctive treatment for full-thickness rotator cuff tears, the current analysis has several proposed advantages that contribute to the body of knowledge surrounding its use. It represents the largest population reported to date of full-thickness rotator cuff tears treated with this implant, with further power drawn from the high proportion of patients available at final follow-up.…”

Section: Bioinductive Implant For Full-thickness Tears E3mentioning

confidence: 99%

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Full-Thickness Rotator Cuff Tears Can Be Safely Treated With a Resorbable Bioinductive Bovine Collagen Implant: One-Year Results of a Prospective, Multicenter Registry

McIntyre¹,

McMillan

Trenhaile³

et al. 2021

Arthroscopy, Sports Medicine, and Rehabilitation

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The purpose of this study was to prospectively collect safety and efficacy data in a large group of patients undergoing arthroscopic repair of full-thickness rotator cuff tears augmented with a resorbable bioinductive bovine collagen implant designed to promote healing. Methods: Seventeen centers across the United States enrolled patients in an institutional review board-approved registry to collect outcomes data on the implant. Patients undergoing surgical management of full-thickness rotator cuff tears augmented with the implant were enrolled. Inclusion criteria were age of !21 years, willingness to participate and the ability to read and speak English. Exclusion criteria included hypersensitivity to bovine-derived products. Patients were assessed before and after surgery at up to 1 year with outcomes including the single-assessment numeric evaluation (SANE), Veterans RAND 12-Item (VR-12) mental components and physical components (VR-12 PCS), American Shoulder and Elbow Surgeons (ASES), and Western Ontario Rotator Cuff (WORC) outcome measures. Ad hoc analyses were performed to compare these outcomes at all time points depending on tear size (small/medium vs large/massive). Serious complications were collected. Results: Of 210 patients enrolled, 192 had 1-year follow-up data available. The patients experienced statistically significant improvement between baseline and 1 year for mean SANE, VR-12 PCS, ASES, and WORC scores (40.0-82.0, 33.5-47.3, 46.2-87.8, and 36.2-81.0, respectively; P < .001 for all results). Ad-hoc analysis demonstrated that similar results were obtained at 1 year regardless of tear size. Twenty patients (10.4%) experienced serious complications (10.4%), including revision surgery (n ¼ 18), proximal humerus fracture/partial subscapularis tear resulting from multiple falls (n ¼ 1), and adhesive capsulitis (n ¼ 1). Conclusions: The safety and efficacy of a bioinductive implant in the surgical management of full-thickness rotator cuff tears at 1 year was shown in this study. Implant efficacy appears to be comparable regardless of the underlying tear size.

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Section: Discussionmentioning

confidence: 99%

Section: Bioinductive Implant For Full-thickness Tears E3mentioning

confidence: 99%

Full-Thickness Rotator Cuff Tears Can Be Safely Treated With a Resorbable Bioinductive Bovine Collagen Implant: One-Year Results of a Prospective, Multicenter Registry

McIntyre¹,

McMillan

Trenhaile³

et al. 2021

Arthroscopy, Sports Medicine, and Rehabilitation

Self Cite

View full text Add to dashboard Cite

show abstract

“…7 Not surprisingly, shoulder surgeons have explored whether augmentation of cuff repair would not only result in better cuff integrity but also reduce retear rates. 5,[8][9][10] An earlier study by Barber et al has been promising reporting intact repairs in 85% compared with 40% in nonaugmented repairs at a mean follow-up of two years. 9 Similarly, Cai et al have shown that graft augmentation with three-dimensional collagen reduced the retear rate to 14% compared with 34% in a control group who underwent arthroscopic repair only.…”

Section: See Related Article On Page 38mentioning

confidence: 97%

“…2 In general, arthroscopic repair is associated with lower risks of adverse events and return to the operating room. 3 However, retear rates range from 10 to 43%, 4,5 and there are no differences in retear rates for open or arthroscopic surgery. 6 Preoperative tear size and retraction are the main reported risk factors for poorer clinical outcomes and retear rates.…”

Section: See Related Article On Page 38mentioning

confidence: 99%

Editorial Commentary: Long Head Biceps Tendon Can Be Used Like a Split Skin Graft: Mesh It and Augment Rotator Cuff Repairs

Hohmann¹

2022

Arthroscopy: The Journal of Arthroscopic & Related Surgery

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Full-thickness tears of the rotator cuff are common, and surgical treatment is indicated in most cases. Arthroscopic repair has become the standard technique, but despite improved surgical techniques, instrumentations, and implants, failure rates continue to be high and can reach 40% and more. Augmented repairs with allograft patches or autograft tissue, such as long head biceps tendon or fascia lata, have been used with mixed results. However, autograft augmentation seems to be resulting in superior outcomes and higher healing rates. Treating skin defects with split-skin grafts is the gold standard in burns and soft-tissue surgery. Given the limited supply of autograft, meshing autograft tendon and using it similar to a split-skin graft is a novel idea. When using a 2:1 expansion ratio, the long head biceps tendon can be formed into a porous scaffold with the in situ tenocytes, producing cytokines and promoting tenogenic differentiation. However, the scaffolds exhibited reduced tensile properties. The results are encouraging, and it will be interesting whether the clinical trials will demonstrate higher healing rates and better functional outcomes when compared to primary repair and allograft patch augmentation.

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“…1,15 Multiple clinical studies have demonstrated that tendon repair augmented with a collagen implant induces significant tendon thickening and tear resolution on MRI by 12 months followup. [2][3][4][5]12,13 Patient-reported clinical scores such as singleassessment numeric evaluation (SANE), American Shoulder and Elbow Surgeons (ASES) scores, and the Western Ontario's Rotator Cuff (WORC) scores have also been shown to improve after repair with a collagen graft. [2][3][4][5]12,13 Despite their promising clinical profile, collagen implants may have potential adverse outcomes, namely subacute reactive bursitis.…”

mentioning

confidence: 99%

Revision arthroscopic surgery after rotator cuff repair with a collagen graft: histologic evaluation of biopsy specimens from two patients

Wietlisbach

Cheema

Huang

et al. 2022

JSES Reviews, Reports, and Techniques

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Retear rates and clinical outcomes at 1 year after repair of full-thickness rotator cuff tears augmented with a bioinductive collagen implant: a prospective multicenter study

Cited by 21 publications

References 51 publications

Full-Thickness Rotator Cuff Tears Can Be Safely Treated With a Resorbable Bioinductive Bovine Collagen Implant: One-Year Results of a Prospective, Multicenter Registry

Full-Thickness Rotator Cuff Tears Can Be Safely Treated With a Resorbable Bioinductive Bovine Collagen Implant: One-Year Results of a Prospective, Multicenter Registry

Editorial Commentary: Long Head Biceps Tendon Can Be Used Like a Split Skin Graft: Mesh It and Augment Rotator Cuff Repairs

Revision arthroscopic surgery after rotator cuff repair with a collagen graft: histologic evaluation of biopsy specimens from two patients

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