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Knee Surgery, Sports Traumatology, Arthroscopy

Published in:

02-03-2023 | Painful Arc | SHOULDER

A pilot randomised controlled trial assessing standard versus dermal patch-augmented rotator cuff repair found no adverse effects and suggest future trials need a minimum of 150 patients

Authors: Martyn Snow, Jan Herman Kuiper, Steven James, Ellie Keeling, Sophie Rich, Priyadarshi Amit

Published in: Knee Surgery, Sports Traumatology, Arthroscopy | Issue 7/2023

Abstract

Purpose

The aims of this pilot randomised controlled trial (RCT) were to assess the safety and efficacy of a human dermal allograft patch and assess the feasibility of a future RCT comparing retear rate and functional outcome 12 months following standard and augmented double-row rotator cuff repair.

Methods

A pilot RCT was conducted among patients undergoing arthroscopic repair of rotator cuff tear measuring between 1 and 5 cm. They were randomised to either augmented (double-row repair with human acellular dermal patch) or standard (double-row repair only). The primary outcome was rotator cuff retear determined on MRI scan at 12 months using the Sugaya’s classification (grade 4 or 5). All adverse events were recorded. Functional assessment was performed at baseline and 3, 6, 9, and 12 months post-surgery using clinical outcome scores. Safety was assessed by complications and adverse effects, and feasibility by recruitment, follow-up rate and proof of concept statistical analyses of a future trial.

Results

Between 2017 and 2019, 63 patients were considered for inclusion. Twenty-three patients were excluded, leaving 40 patients (20 per group) in the final study population. The mean tear sizes were 3.0 cm in the augmented and 2.4 cm in the standard group. There was one adhesive capsulitis in the augmented group, with no other adverse events. Retear was observed in 4/18 (22%) of patients in the augmented and 5/18 (28%) in the standard group. In both groups, functional outcome improved significantly which was clinically meaningful for all scores, with no difference between groups. Retear rate increased with tear size. Future trials are feasible but need a minimum total sample size of 150 patients.

Conclusion

Clinically meaningful improved function without adverse effects was found with human acellular dermal patch-augmented cuff repairs.

Level of evidence

Level II.

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Title: A pilot randomised controlled trial assessing standard versus dermal patch-augmented rotator cuff repair found no adverse effects and suggest future trials need a minimum of 150 patients
Authors: Martyn Snow
Jan Herman Kuiper
Steven James
Ellie Keeling
Sophie Rich
Priyadarshi Amit
Publication date: 02-03-2023
Publisher: Springer Berlin Heidelberg
Keyword: Painful Arc
Published in: Knee Surgery, Sports Traumatology, Arthroscopy / Issue 7/2023
Print ISSN: 0942-2056
Electronic ISSN: 1433-7347
DOI: https://doi.org/10.1007/s00167-023-07356-5

Keynote webinar | Spotlight on medication adherence

Springer Medicine

A pilot randomised controlled trial assessing standard versus dermal patch-augmented rotator cuff repair found no adverse effects and suggest future trials need a minimum of 150 patients

Abstract

Purpose

Methods

Results

Conclusion

Level of evidence

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Purpose

Methods

Results

Conclusion

Level of evidence

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