Rotator Cuff Tendinitis, Rotator Cuff Tendinosis, Shoulder Pain, Tendinopathy
Conditions
Keywords
rotator cuff tendinopathy
Brief 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.
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.
Interventions
BIOLOGICALCTM 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.
BIOLOGICALPRP
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.
Sponsors
Connective Tissue Matrix Biomedical, LLC
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
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. Each 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
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| determine if injection of CTM Boost is non-inferior to injection of PRP | 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
| Measure | Time frame | Description |
|---|---|---|
| assessment of superiority of CTM to PRP (if non-inferiority established)/ WORC Score | 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. |
| assessment of superiority of CTM to PRP (if non-inferiority established) / VAS Pain Scale | 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'). |
| assessment of superiority of CTM to PRP (if non-inferiority established) / SANE | 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. |
| assessment of superiority of CTM to PRP (if non-inferiority established) / ASES | 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 |
| assessment of superiority of CTM to PRP (if non-inferiority established) / empty can exercise | Each visit up to 24 months | empty can exercise with dumbbell resistance (number of seconds to fatigue) |
| Mean Western Ontario Rotator Cuff Index (WORC) Score | 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. |
| assessment of superiority of CTM to PRP (if non-inferiority established) / full can with dumbbell resistance | Each visit up to 24 months | Full can exercise with dumbbell resistance (number of repetitions in 60 seconds) |
| assessment of superiority of CTM to PRP (if non-inferiority established) / external rotation at 0 and 90 degrees | Each visit up to 24 months | External rotation at 0 and 90 degrees with Thera-Band resistance (number of seconds to fatigue) |
| safety of injection of CTM boost compared to PRP | 6 months | number of adverse events |
| severity of tendinopathy | 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 |
| assessment of superiority of CTM to PRP (if non-inferiority established) | 6 months | serum levels of inflammatory cytokines IL-1β and TNF-α as well as serum level of Fibroblast growth factor (FGF) |
| assessment of superiority of CTM to PRP (if non-inferiority established) / side laying external rotation with dumbbell resistance | Each visit up to 24 months | Side-lying external rotation with dumbbell resistance (number of repetitions in 30 seconds) |
Countries
United States
Outcome results
None listed