Clinical trial

Connective Tissue Matrix (CTM) for Rotator Cuff Tendinopathy: A Randomized Controlled Trial

Name

2023-264-FN

Description

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.

Trial arms

Trial start

2023-12-04

Estimated PCD

2027-01-15

Trial end

2028-01-15

Status

Recruiting

Phase

Early phase I

Treatment

CTM Boost

Connective Tissue Matrix (CTM) Boost is a decellularized Human Cellular and Tissue Based Allograft derived from placental connective tissue. It is considered a minimally-manipulated biologic by the FDA and is marketed as an allograft for repairing connective tissue. It is administered via injection.

Arms:

CTM Treatment

PRP

PRP is derived by a sample of blood drawn from a patient and concentrated to include mainly platelets and potent inflammatory mediators which promote healing. At baseline, a blood draw of 60 milliliter (mL) will be obtained and concentrated in an Angel System to yield 5 cc of PRP and a supra-physiological concentration of white blood cells. All injections will be done under ultrasound guidance. A two-part injection process will be used. An advancing 20 gauge 1.5-inch needle first placed 3 mL of 1% xylocaine proximal to the tendinopathic area or tear. The needle will then be re-inserted at the proximal aspect of the lesion and slowly removed while infiltrating of 5 mL of PRP without activation with Calcium Chloride/thrombin at the lesion and surrounding tendon.

Arms:

PRP Treatment

Size

Primary endpoint

determine if injection of CTM Boost is non-inferior to injection of PRP

6 months

Eligibility criteria

Inclusion Criteria: * 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 Criteria: * 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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two-arm, double-blinded, randomized controlled trial with the primary objective of evaluating non-inferiority of CTM (study intervention arm) to PRP (active comparator arm) for rotator cuff tendinopathy pain and function.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': '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.\n\nEach 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', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 92, 'type': 'ESTIMATED'}}

Updated at

2024-03-15

1 organization

2 products

3 indications

Organization

Allegheny Health Network Research Institute

Product

CTM Boost

Indication

tendinopathy

Indication

Shoulder Pain

Indication

Rotator Cuff Tendinitis

Product

PRP