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Active, Not Recruiting

NCT Number: NCT06160427

Connective Tissue Matrix for Rotator Cuff Tendinopathy

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Tendinopathy Arthralgia Joint Diseases Muscular Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Rotator Cuff Injuries Rotator Cuff Tendinitis Rotator Cuff Tendinosis Rupture Shoulder Injuries Shoulder Pain Signs and Symptoms Tendon Injuries Wounds and Injuries

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Allegheny Health Network Allegheny General Hospital, Pittsburgh, Pennsylvania, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CTM Boost

Biological

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.

PRP

Biological

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Mean Western Ontario Rotator Cuff Index (WORC) Score

    Time frame: at 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.

  2. assessment of superiority of CTM to PRP (if non-inferiority established)/ WORC Score

    Time frame: Each visit up to 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.

  3. assessment of superiority of CTM to PRP (if non-inferiority established) / VAS Pain Scale

    Time frame: Each visit up to 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').

  4. assessment of superiority of CTM to PRP (if non-inferiority established) / SANE

    Time frame: Each visit up to 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.

  5. assessment of superiority of CTM to PRP (if non-inferiority established) / ASES

    Time frame: Each visit up to 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

  6. assessment of superiority of CTM to PRP (if non-inferiority established) / empty can exercise

    Time frame: Each visit up to 24 months

    empty can exercise with dumbbell resistance (number of seconds to fatigue)

  7. assessment of superiority of CTM to PRP (if non-inferiority established) / side laying external rotation with dumbbell resistance

    Time frame: Each visit up to 24 months

    Side-lying external rotation with dumbbell resistance (number of repetitions in 30 seconds)

  8. assessment of superiority of CTM to PRP (if non-inferiority established) / full can with dumbbell resistance

    Time frame: Each visit up to 24 months

    Full can exercise with dumbbell resistance (number of repetitions in 60 seconds)

  9. assessment of superiority of CTM to PRP (if non-inferiority established) / external rotation at 0 and 90 degrees

    Time frame: Each visit up to 24 months

    External rotation at 0 and 90 degrees with Thera-Band resistance (number of seconds to fatigue)

  10. safety of injection of CTM boost compared to PRP

    Time frame: 6 months

    number of adverse events

  11. 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

  12. 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)

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Connective Tissue Matrix Biomedical, LLC

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Dec 7, 2023
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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