Status:
UNKNOWN
Regeneten Patch vs Standard Care in Partial Thickness Rotator Cuff Repair
Lead Sponsor:
Rothman Institute Orthopaedics
Conditions:
Rotator Cuff Tears
Shoulder Surgery
Eligibility:
All Genders
40-75 years
Phase:
NA
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 degenerati...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2021
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04673344
Start Date
December 30 2020
End Date
December 31 2021
Last Update
December 17 2020
Active Locations (1)
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1
Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, United States, 19107