Regeneten Patch vs Standard Care in Partial Thickness Rotator Cuff Repair

Rotator Cuff Tears Clinical Trial

Official title:

Collagen Scaffold Augmentation of High Grade Partial Rotator Cuff Tendon Tears Improves Early Functional Recovery: A Randomized Controlled Trial.

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04673344
• Other study ID #: FTJO2020-0876
• Status: Enrolling by invitation
• Phase: N/A
• Start date: December 30, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: December 2020
• Source: Rothman Institute Orthopaedics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 80
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Rotator Cuff Tears
• Shoulder Surgery

Intervention

Device:
• Regeneten Collagen Patch
Partial rotator cuff repair surgery with the addition of the Regeneten scaffold

Locations

Country	Name	City	State
United States	Rothman Orthopaedic Institute	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Rothman Institute Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rotator Cuff Healing	The status of rotator cuff healing as demonstrated on post-operative MRI (at 6, 12 and 24 months)	24 months
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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