Regeneten Patch vs Standard Care in Partial Thickness Rotator Cuff Repair

NCT04673344 | Unknown FDA Device

• 1 other identifier: FTJO2020-0876
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rotator Cuff Tears; Shoulder Surgery

Outcome Measures

Primary Outcomes (6)

• Rotator Cuff Healing

  The status of rotator cuff healing as demonstrated on post-operative MRI (at 6, 12 and 24 months)

  24 months

• Participant Satisfaction: ASES assessment

  Participant Satisfaction with their surgical outcomes will be measured with the use of the American Shoulder and Elbow Surgeons at 6 week, 3-, 6-, 12- and 24 months after surgery

  24 months

• Participant Satisfaction: WORC assessment

  Participant Satisfaction with their surgical outcomes will be measured with the use of the Western Ontario Rotator Cuff Index at 6 week, 3-, 6-, 12- and 24 months after surgery

  24 months

• Participant Satisfaction: SANE assessment

  Participant Satisfaction with their surgical outcomes will be measured with the use of the Single Assessment Numeric Evaluation at 6 week, 3-, 6-, 12- and 24 months after surgery

  24 months

• Participant Satisfaction: VR-12 assessment

  Participant Satisfaction with their surgical outcomes will be measured with the use of the Veteran's Rand 12 assessment at 6 week, 3-, 6-, 12- and 24 months after surgery

  24 months

• Participant Satisfaction: GRC assessment

  Participant Satisfaction with their surgical outcomes will be measured with the use of the Global Rating of Change scale at 6 week, 3-, 6-, 12- and 24 months after surgery

  24 months

Study Arms (2)

Partial Rotator Cuff Repair

NO INTERVENTION

Routine partial rotator cuff repair

Partial Rotator Cuff Repair with Regeneten Scaffold

ACTIVE COMPARATOR

Routine partial rotator cuff repair with the addition of the Regeneten scaffolding patch

Device: Regeneten Collagen Patch

Interventions

Regeneten Collagen Patch DEVICE

Partial rotator cuff repair surgery with the addition of the Regeneten scaffold

Partial Rotator Cuff Repair with Regeneten Scaffold

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females aged 40-75 years with a partial-thickness rotator cuff tear (50% or more) confirmed on MRI scan that, in combination with patient-report symptoms and clinical examination by the orthopaedic surgeon, would confirm the rotator cuff tear as the primary pathology driving pain, symptoms and functional disability .
• Symptoms \> 3 months
• Unsuccessful conservative treatment comprising of a corticosteroid injection (into the subacromial bursa) and physiotherapy (while it is acknowledged that a range of modalities may be available to patient's presenting with apparent symptomatic rotator cuff pathology, for the current study, physiotherapy has been defined specifically as a course of 'exercise-based' therapy specific to the individual patient, though generally comprising of exercises designed to strengthen the rotator cuff and scapula stabilizing musculature, improving flexibility and shoulder mobility)

You may not qualify if:

• Revision surgery
• Cervical pathology
• Adhesive capsulitis
• Multi-tendon tears
• Concomitant upper limb pathology (eg: arthritis, nerve compression)
• Infection
• Previous fracture
• Instability
• Pregnancy and lactation
• Professional athlete
• Worker's compensation or compensable claim
• Substance abuse or current mental illness
• Smoker
• Adverse reaction to bovine derived products

Sponsors & Collaborators

• Rothman Institute Orthopaedics: lead

Study Sites (1)

Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2020
• First Posted: December 17, 2020
• Study Start: December 30, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: December 17, 2020

Record last verified: 2020-12

Locations

US (1)