Thon, Am J Sports Med 2019 - Evaluation of Healing Rates and Safety with a Bioinductive Collagen Patch for Large and Massive Rotator Cuff Tears: 2-Year Safety and Clinical Outcomes - Article Summary

Evaluation of Healing Rates and Safety with a Bioinductive Collagen Patch for Large and Massive Rotator Cuff Tears: 2-Year Safety and Clinical Outcomes

Thon, Savoie, et al.·Am J Sports Med·2019·126 citations·Case series

Background

Failure of repair of large and massive rotator cuff tears is a challenging problem within orthopaedics. Poor tendon tissue and vascularity are known causes for failure of rotator cuff repairs.

Purpose

To assess the safety, outcomes, and healing rates when large and massive rotator cuff repairs are augmented with a bioinductive collagen scaffold patch in a proof-of-principle design.

Methods

Study Design: Case series; Level of evidence, 4.

23 patients undergoing repair of full-thickness large (2-tendon) or massive (3-tendon) rotator cuff tears augmented with a bioinductive collagen patch were enrolled in a prospective single-arm proof-of-principle study.
No partial repairs were performed, and a complete rotator cuff repair was successfully achieved in each case.
16 patients underwent revision rotator cuff repairs versus 7 primary repairs.
Safety was determined by any implant-related adverse event.
A single magnetic resonance imaging (MRI) scan was utilized to confirm tendon healing and thickness at a minimum of 6 months postoperatively.
Postoperative ultrasound (US) was used in office by the treating surgeon to assess tendon thickness at 3-, 6-, 12-, and 24-month intervals.
American Shoulder and Elbow Surgeons (ASES) scores were collected at final follow-up.

Results

Overall, a 96% (22 of 23) healing rate was confirmed on US and MRI.
However, incidence of treatment clinical failure was 9% (2 of 23), as 1 patient's tendon healed but eventually underwent additional surgery.
There were no adverse events attributed to the implant reported.
Final US rotator cuff thickness was 7.28 ± 0.85 mm (mean ± SD), and final MRI rotator cuff thickness was 5.13 ± 1.06 mm.
The mean ASES score at final follow-up was 82.87 ± 16.68 (range, 53.33-100).

Conclusions

No complications attributed to the implant were reported, and new tendon formation was apparent on US and MRI, with relatively high healing rates at 2-year follow-up. Arthroscopic application of this bioinductive collagen scaffold when combined with rotator cuff repair is a safe and effective treatment for healing of large and massive rotator cuff repairs.

Supplemental

Evaluation of Healing Rates and Safety with a Bioinductive Collagen Patch for Large and Massive Rotator Cuff Tears: 2-Year Safety and Clinical Outcomes.

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Evaluation of Healing Rates and Safety with a Bioinductive Collagen Patch for Large and Massive Rotator Cuff Tears: 2-Year Safety and Clinical Outcomes

Thon, Savoie, et al.·Am J Sports Med·2019·126 citations·Case series

DOI·PubMed

Background

Failure of repair of large and massive rotator cuff tears is a challenging problem within orthopaedics. Poor tendon tissue and vascularity are known causes for failure of rotator cuff repairs.

Purpose

To assess the safety, outcomes, and healing rates when large and massive rotator cuff repairs are augmented with a bioinductive collagen scaffold patch in a proof-of-principle design.

Methods

Study Design: Case series; Level of evidence, 4.

23 patients undergoing repair of full-thickness large (2-tendon) or massive (3-tendon) rotator cuff tears augmented with a bioinductive collagen patch were enrolled in a prospective single-arm proof-of-principle study.
No partial repairs were performed, and a complete rotator cuff repair was successfully achieved in each case.
16 patients underwent revision rotator cuff repairs versus 7 primary repairs.
Safety was determined by any implant-related adverse event.
A single magnetic resonance imaging (MRI) scan was utilized to confirm tendon healing and thickness at a minimum of 6 months postoperatively.
Postoperative ultrasound (US) was used in office by the treating surgeon to assess tendon thickness at 3-, 6-, 12-, and 24-month intervals.
American Shoulder and Elbow Surgeons (ASES) scores were collected at final follow-up.

Results

Overall, a 96% (22 of 23) healing rate was confirmed on US and MRI.
However, incidence of treatment clinical failure was 9% (2 of 23), as 1 patient's tendon healed but eventually underwent additional surgery.
There were no adverse events attributed to the implant reported.
Final US rotator cuff thickness was 7.28 ± 0.85 mm (mean ± SD), and final MRI rotator cuff thickness was 5.13 ± 1.06 mm.
The mean ASES score at final follow-up was 82.87 ± 16.68 (range, 53.33-100).

Conclusions

Background

Failure of repair of large and massive rotator cuff tears is a challenging problem within orthopaedics. Poor tendon tissue and vascularity are known causes for failure of rotator cuff repairs.

Purpose

To assess the safety, outcomes, and healing rates when large and massive rotator cuff repairs are augmented with a bioinductive collagen scaffold patch in a proof-of-principle design.

Methods

Study Design: Case series; Level of evidence, 4.

23 patients undergoing repair of full-thickness large (2-tendon) or massive (3-tendon) rotator cuff tears augmented with a bioinductive collagen patch were enrolled in a prospective single-arm proof-of-principle study.
No partial repairs were performed, and a complete rotator cuff repair was successfully achieved in each case.
16 patients underwent revision rotator cuff repairs versus 7 primary repairs.
Safety was determined by any implant-related adverse event.
A single magnetic resonance imaging (MRI) scan was utilized to confirm tendon healing and thickness at a minimum of 6 months postoperatively.
Postoperative ultrasound (US) was used in office by the treating surgeon to assess tendon thickness at 3-, 6-, 12-, and 24-month intervals.
American Shoulder and Elbow Surgeons (ASES) scores were collected at final follow-up.

Results

Overall, a 96% (22 of 23) healing rate was confirmed on US and MRI.
However, incidence of treatment clinical failure was 9% (2 of 23), as 1 patient's tendon healed but eventually underwent additional surgery.
There were no adverse events attributed to the implant reported.
Final US rotator cuff thickness was 7.28 ± 0.85 mm (mean ± SD), and final MRI rotator cuff thickness was 5.13 ± 1.06 mm.
The mean ASES score at final follow-up was 82.87 ± 16.68 (range, 53.33-100).

Conclusions

Background

Failure of repair of large and massive rotator cuff tears is a challenging problem within orthopaedics. Poor tendon tissue and vascularity are known causes for failure of rotator cuff repairs.

Purpose

To assess the safety, outcomes, and healing rates when large and massive rotator cuff repairs are augmented with a bioinductive collagen scaffold patch in a proof-of-principle design.

Methods

Study Design: Case series; Level of evidence, 4.

23 patients undergoing repair of full-thickness large (2-tendon) or massive (3-tendon) rotator cuff tears augmented with a bioinductive collagen patch were enrolled in a prospective single-arm proof-of-principle study.
No partial repairs were performed, and a complete rotator cuff repair was successfully achieved in each case.
16 patients underwent revision rotator cuff repairs versus 7 primary repairs.
Safety was determined by any implant-related adverse event.
A single magnetic resonance imaging (MRI) scan was utilized to confirm tendon healing and thickness at a minimum of 6 months postoperatively.
Postoperative ultrasound (US) was used in office by the treating surgeon to assess tendon thickness at 3-, 6-, 12-, and 24-month intervals.
American Shoulder and Elbow Surgeons (ASES) scores were collected at final follow-up.

Results

Overall, a 96% (22 of 23) healing rate was confirmed on US and MRI.
However, incidence of treatment clinical failure was 9% (2 of 23), as 1 patient's tendon healed but eventually underwent additional surgery.
There were no adverse events attributed to the implant reported.
Final US rotator cuff thickness was 7.28 ± 0.85 mm (mean ± SD), and final MRI rotator cuff thickness was 5.13 ± 1.06 mm.
The mean ASES score at final follow-up was 82.87 ± 16.68 (range, 53.33-100).