Connective Tissue Matrix for Rotator Cuff Tendinopathy

Last updated: March 14, 2024
Sponsor: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Overall Status: Active - Recruiting

Phase

4

Condition

Sprains

Tendon Injuries

Treatment

CTM Boost

PRP

Clinical Study ID

NCT06160427
2023-264-FN
  • Ages 18-80
  • All Genders

Study 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 injection of platelet rich plasma (PRP) in reducing the symptoms of RCT.

Eligibility Criteria

Inclusion

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 medicaltreatment course and patient is willing to undergo the injection

Exclusion

Exclusion Criteria:

  • Patients with adhesive capsulitis
  • Patients with acromio-clavicular joint impingement, retracted tears, significantlabral 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 renaldisease or uncontrolled diabetes

Study Design

Total Participants: 92
Treatment Group(s): 2
Primary Treatment: CTM Boost
Phase: 4
Study Start date:
December 04, 2023
Estimated Completion Date:
January 15, 2028

Study 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 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.

Connect with a study center

  • Allegheny Health Network Allegheny General Hospital

    Pittsburgh, Pennsylvania 15212
    United States

    Active - Recruiting

  • Allegheny Health Network Federal North Medical Office Building

    Pittsburgh, Pennsylvania 15212
    United States

    Active - Recruiting

  • AHN Wexford Health & Wellness Pavilion

    Wexford, Pennsylvania 15090
    United States

    Active - Recruiting

  • AHN Wexford Hospital

    Wexford, Pennsylvania 15090
    United States

    Active - Recruiting

  • Alleghney Health Network Wexford Health & Wellness Pavilion

    Wexford, Pennsylvania 15090
    United States

    Site Not Available

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