Last updated: December 14, 2020
Sponsor: Rothman Institute Orthopaedics
Overall Status: Active - Enrolling
Phase
N/A
Condition
Orthopedic Surgery
Orthopedics
Treatment
N/AClinical Study ID
NCT04673344
FTJO2020-0876
Ages 40-75 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Males and females aged 40-75 years with a partial-thickness rotator cuff tear (50% ormore) confirmed on MRI scan that, in combination with patient-report symptoms andclinical examination by the orthopaedic surgeon, would confirm the rotator cuff tearas the primary pathology driving pain, symptoms and functional disability .
- Symptoms > 3 months
- Unsuccessful conservative treatment comprising of a corticosteroid injection (into thesubacromial bursa) and physiotherapy (while it is acknowledged that a range ofmodalities may be available to patient's presenting with apparent symptomatic rotatorcuff pathology, for the current study, physiotherapy has been defined specifically asa course of 'exercise-based' therapy specific to the individual patient, thoughgenerally comprising of exercises designed to strengthen the rotator cuff and scapulastabilizing musculature, improving flexibility and shoulder mobility)
Exclusion
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
Study Design
Total Participants: 80
Study Start date:
December 30, 2020
Estimated Completion Date:
December 31, 2021
Connect with a study center
Rothman Orthopaedic Institute
Philadelphia, Pennsylvania 19107
United StatesSite Not Available
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.