Connective Tissue Matrix for Rotator Cuff Tendinopathy (CTM RCT)

March 14, 2024 updated by: Patrick DeMeo, MD, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 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

Enrollment (Estimated)

92

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15212
        • Recruiting
        • Allegheny Health Network Allegheny General Hospital
        • Sub-Investigator:
          • Edward Snell, MD
        • Contact:
        • Contact:
        • Principal Investigator:
          • Patrick Demeo, MD
      • Pittsburgh, Pennsylvania, United States, 15212
        • Recruiting
        • Allegheny Health Network Federal North Medical Office Building
        • Sub-Investigator:
          • Edward Snell, MD
        • Contact:
        • Contact:
        • Principal Investigator:
          • Patrick Demeo, MD
      • Wexford, Pennsylvania, United States, 15090
        • Recruiting
        • AHN Wexford Hospital
        • Sub-Investigator:
          • Edward Snell, MD
        • Contact:
        • Contact:
        • Principal Investigator:
          • Patrick Demeo, MD
      • Wexford, Pennsylvania, United States, 15090
        • Recruiting
        • AHN Wexford Health & Wellness Pavilion
        • Sub-Investigator:
          • Edward Snell, MD
        • Contact:
        • Contact:
        • Principal Investigator:
          • Patrick Demeo, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CTM Treatment
2.0 cc (cubic centimeter) dose injection of CTM Boost will be administered by injection directly into the rotator cuff using a 20 gauge needle.
Biological: 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.
Active Comparator: PRP Treatment
Each participant randomized to this arm will receive a single injection of Platelet Rich Plasma (PRP).
Biological: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
determine if injection of CTM Boost is non-inferior to injection of PRP
Time Frame: 6 months
Mean Western Ontario Rotator Cuff Index (WORC) Score The WORC has 21 items in four domains, including physical symptoms (10 questions), sports/recreation/work (4 questions), lifestyle (4 questions) and emotions (3 questions). Raw scores range from 0 to 2100, with a higher score indicating decreased quality of life because of pathological condition of the rotator cuff.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
assessment of superiority of CTM to PRP (if non-inferiority established)
Time Frame: 6 months
Mean Western Ontario Rotator Cuff Index (WORC) Score The WORC has 21 items in four domains, including physical symptoms (10 questions), sports/recreation/work (4 questions), lifestyle (4 questions) and emotions (3 questions). Raw scores range from 0 to 2100, with a higher score indicating decreased quality of life because of pathological condition of the rotator cuff.
6 months
assessment of superiority of CTM to PRP (if non-inferiority established)
Time Frame: thru 24 months
Mean Western Ontario Rotator Cuff Index (WORC) Score The WORC has 21 items in four domains, including physical symptoms (10 questions), sports/recreation/work (4 questions), lifestyle (4 questions) and emotions (3 questions). Raw scores range from 0 to 2100, with a higher score indicating decreased quality of life because of pathological condition of the rotator cuff.
thru 24 months
assessment of superiority of CTM to PRP (if non-inferiority established)
Time Frame: thru 24 months
Visual Analog Scale (VAS) pain scale The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').
thru 24 months
assessment of superiority of CTM to PRP (if non-inferiority established)
Time Frame: thru 24 months
Single Assessment Numeric Evaluation (SANE) The Single Assessment Numeric Evaluation (SANE) is a patient rating from 0-100. Patients rate their current illness score in relation to their pre-injury baseline. SANE scores are most commonly used by orthopedic sports specialist surgeons, and usually for the shoulder and the knee.
thru 24 months
assessment of superiority of CTM to PRP (if non-inferiority established)
Time Frame: thru 24 months
American Shoulder and Elbow Surgeons Shoulder (ASES) Score The ASES score is a 10-item measure of shoulder pain and function. Pain is assessed on a 10-cm visual analog scale (VAS) and accounts for 50% of the total score. The remaining 50% of the score is determined by the responses to 10 4-point Likert-scale questions related to physical function
thru 24 months
assessment of superiority of CTM to PRP (if non-inferiority established)
Time Frame: thru 24 months
empty can exercise with dumbbell resistance (number of seconds to fatigue)
thru 24 months
assessment of superiority of CTM to PRP (if non-inferiority established)
Time Frame: thru 24 months
Side-lying external rotation with dumbbell resistance (number of repetitions in 30 seconds)
thru 24 months
assessment of superiority of CTM to PRP (if non-inferiority established)
Time Frame: thru 24 months
Full can exercise with dumbbell resistance (number of repetitions in 60 seconds)
thru 24 months
assessment of superiority of CTM to PRP (if non-inferiority established)
Time Frame: thru 24 months
External rotation at 0 and 90 degrees with Thera-Band resistance (number of seconds to fatigue)
thru 24 months
safety of injection of CTM boost compared to PRP
Time Frame: 6 months
number of adverse events
6 months
severity of tendinopathy
Time Frame: 6 months
Magnetic Resonance Imaging (MRI)-based grading scale MRIs will be scored on rubric from 0-5: 0, no tendinopathy; 1, mild tendinopathy; 2, moderate tendinopathy; 3, moderate tendinopathy + partial thickness tear present; 4, severe tendinopathy +partial thickness tear present; 5, severe tendinopathy + full thickness tear present
6 months
assessment of superiority of CTM to PRP (if non-inferiority established)
Time Frame: 6 months
serum levels of inflammatory cytokines IL-1β and TNF-α as well as serum level of Fibroblast growth factor (FGF)
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

Collaborators

Connective Tissue Matrix Biomedical, LLC

Investigators

  • Principal Investigator: Patrick Demeo, MD, Allegheny Health Network

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 4, 2023

Primary Completion (Estimated)

January 15, 2027

Study Completion (Estimated)

January 15, 2028

Study Registration Dates

First Submitted

November 29, 2023

First Submitted That Met QC Criteria

November 29, 2023

First Posted (Actual)

December 7, 2023

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 14, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-264-FN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Tendinopathy

Clinical Trials on CTM Boost

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Romania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe