Status:
ACTIVE_NOT_RECRUITING
Connective Tissue Matrix for Rotator Cuff Tendinopathy
Lead Sponsor:
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Collaborating Sponsors:
Connective Tissue Matrix Biomedical, LLC
Conditions:
Tendinopathy
Shoulder Pain
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
The purpose of this research study is to determine if the effectiveness of a single injection of CTM Boost in the treatment of patients with rotator cuff tendinopathy (RCT) is as effective as a single...
Detailed Description
Rotator cuff tendinopathy (RCT), is a chronic degenerative process which causes both shoulder pain as well as limited range of motion. It is currently estimated that approximately 5% of RCT is being m...
Eligibility Criteria
Inclusion
- Patients aged 18-80 years old with rotator cuff tendinopathy
- A PRP or CTM-type injection was determined by the clinician to be the proper medical treatment course and patient is willing to undergo the injection
Exclusion
- Patients with adhesive capsulitis
- Patients with acromio-clavicular joint impingement, retracted tears, significant labral lesions or significant glenohumeral arthrosis
- Patients with joint instability
- History of shoulder surgery or corticosteroid injection in the past 3 months
- Patients with any medical conditions that affect healing, such as end-stage renal disease or uncontrolled diabetes
Key Trial Info
Start Date :
December 4 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 15 2028
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT06160427
Start Date
December 4 2023
End Date
January 15 2028
Last Update
September 8 2025
Active Locations (4)
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1
Allegheny Health Network Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
2
Allegheny Health Network Federal North Medical Office Building
Pittsburgh, Pennsylvania, United States, 15212
3
AHN Wexford Health & Wellness Pavilion
Wexford, Pennsylvania, United States, 15090
4
AHN Wexford Hospital
Wexford, Pennsylvania, United States, 15090