NCT04673344

Regeneten Patch vs Standard Care in Partial Thickness Rotator Cuff Repair

Status unknown NA Last updated 17 December 2020

What this trial tests

NA trial testing Regeneten Collagen Patch in Rotator Cuff Tears in 80 participants. Status unknown.

Timeline

30 December 2020

Primary endpoint
31 December 2021

31 December 2021

Quick facts

Lead sponsor	Rothman Institute Orthopaedics
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	80
Start date	30 December 2020
Primary completion	31 December 2021
Estimated completion	31 December 2021
Sites	1 location across United States

Drugs / interventions tested

• Regeneten Collagen Patch

Conditions studied

• Rotator Cuff Tears — all drugs for Rotator Cuff Tears →
• Shoulder Surgery — all drugs for Shoulder Surgery →

Sponsor

Rothman Institute Orthopaedics

Who can join

Adults 40 to 75, any sex, with Rotator Cuff Tears or Shoulder Surgery. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Shoulder pain is a common complaint with the most common reason being tendinopathy and/or tearing of the rotator cuff. While many rotator cuff tears are often considered normal, age-related degenerative disorders, with either partial- or full-thickness rotator cuff tears evident in 4% of patients aged \<40 years and in 54% of patients aged \>60 years, once they become symptomatic and conservative management fails, they are typically repaired surgically. Data suggest that the incidence of surgery to repair and re-attach the cuff continues to rise. However, despite positive clinical results overall, reports of repair failure after surgery can range from 16%-94%, and of those that do fail, or fail to heal, generally do so within the first 3 to 6 months post-surgery.

Given the aforementioned reported issues with the gold standard for the treatment of unresponsive and symptomatic partial or full rotator cuff tears (surgical repair), together with the invasiveness of this surgery and lengthy period of restricted activity, other means of treatment have been proposed.

The REGENETEN scaffold/implant seeks to support new tendon growth and disrupt disease progression. This study seeks to investigate the outcome of surgical rotator cuff repair versus scaffold augmentation (using the REGENETEN scaffold) for symptomatic partial thickness rotator cuff tears.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Commercial Biomaterial-Based Products for Tendon Surgical Augmentation: A Scoping Review on Currently Available Medical Devices.
   Pluchino M, Vivarelli L, Giavaresi G, Dallari D, et al · · 2025 · cited 2× · PMID 40278238 · DOI 10.3390/jfb16040130