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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
92
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 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.
Allegheny Health Network Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
Allegheny Health Network Federal North Medical Office Building
Pittsburgh, Pennsylvania, United States
AHN Wexford Health & Wellness Pavilion
Wexford, Pennsylvania, United States
AHN Wexford Hospital
Wexford, Pennsylvania, United States
determine if injection of CTM Boost is non-inferior to injection of PRP
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.
Time frame: 6 months
Mean Western Ontario Rotator Cuff Index (WORC) Score
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.
Time frame: at 6 months
assessment of superiority of CTM to PRP (if non-inferiority established)/ WORC Score
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.
Time frame: Each visit up to 24 months
assessment of superiority of CTM to PRP (if non-inferiority established) / VAS Pain Scale
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').
Time frame: Each visit up to 24 months
assessment of superiority of CTM to PRP (if non-inferiority established) / SANE
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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.
Time frame: Each visit up to 24 months
assessment of superiority of CTM to PRP (if non-inferiority established) / ASES
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
Time frame: Each visit up to 24 months
assessment of superiority of CTM to PRP (if non-inferiority established) / empty can exercise
empty can exercise with dumbbell resistance (number of seconds to fatigue)
Time frame: Each visit up to 24 months
assessment of superiority of CTM to PRP (if non-inferiority established) / side laying external rotation with dumbbell resistance
Side-lying external rotation with dumbbell resistance (number of repetitions in 30 seconds)
Time frame: Each visit up to 24 months
assessment of superiority of CTM to PRP (if non-inferiority established) / full can with dumbbell resistance
Full can exercise with dumbbell resistance (number of repetitions in 60 seconds)
Time frame: Each visit up to 24 months
assessment of superiority of CTM to PRP (if non-inferiority established) / external rotation at 0 and 90 degrees
External rotation at 0 and 90 degrees with Thera-Band resistance (number of seconds to fatigue)
Time frame: Each visit up to 24 months
safety of injection of CTM boost compared to PRP
number of adverse events
Time frame: 6 months
severity of tendinopathy
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
Time frame: 6 months
assessment of superiority of CTM to PRP (if non-inferiority established)
serum levels of inflammatory cytokines IL-1β and TNF-α as well as serum level of Fibroblast growth factor (FGF)
Time frame: 6 months