Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Patrick Demeo, MD
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 injection of platelet rich plasma (PRP) in reducing the symptoms of RCT.
Tendinopathy
Shoulder Pain
Rotator Cuff Tendinitis
Rotator Cuff Tendinosis
CTM Boost
PRP
PHASE4
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 managed surgically, which highlights the importance of effective non-operative treatment strategies. The advent of platelet rich plasma (PRP), a sample of blood drawn from a patient and concentrated to include mainly platelets and potent inflammatory mediators which promote healing, has shown promise as another treatment modality when injected at the site of tendon damage. Placenta-derived decellularized connective tissue matrix (CTM) may represent an alternative therapy for RCT. Placenta-derived biologics can be administered as an injection and have been shown to promote tenocyte proliferation and to reduce inflammation in vitro, thus potentially accelerating and enhancing tendon healing. This study is being conducted to determine if injection of CTM Boost is non-inferior to injection of PRP with regard to pain and function at Month 6 post-injection in patients with rotator cuff tendinopathy.
| Study Type : | INTERVENTIONAL |
| Estimated Enrollment : | 92 participants |
| Masking : | TRIPLE |
| Masking Description : | Participants will be randomized to one of the two arms by unblinded research personnel. Unblinded key study personnel will prepare the injection of either CTM Boost or PRP using an opaque sleeve to obscure the contents of the injection. Both patients and investigators will be blinded to treatment arm. Each participant will undergo an antecubital blood draw of 60 milliliers (mL). Staff will wait about 20 minutes after the blood draw to injection time. This will be done to maintain blinding due to the 17 minutes it takes for the system to produce PRP. For patients in the CTM arm, the PRP blood draw serves as a placebo draw and the specimen will be discarded afterwards, in order to maintain blinding |
| Primary Purpose : | TREATMENT |
| Official Title : | Connective Tissue Matrix (CTM) for Rotator Cuff Tendinopathy: A Randomized Controlled Trial |
| Actual Study Start Date : | 2023-12-04 |
| Estimated Primary Completion Date : | 2027-01-15 |
| Estimated Study Completion Date : | 2028-01-15 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 18 Years to 80 Years |
| Sexes Eligible for Study: | ALL |
| Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
RECRUITING
Allegheny Health Network Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
RECRUITING
Allegheny Health Network Federal North Medical Office Building
Pittsburgh, Pennsylvania, United States, 15212
RECRUITING
AHN Wexford Health & Wellness Pavilion
Wexford, Pennsylvania, United States, 15090
RECRUITING
AHN Wexford Hospital
Wexford, Pennsylvania, United States, 15090