Connective Tissue Matrix (CTM) for Rotator Cuff Tendinopathy: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 92
- 试验地点
- 4
- 主要终点
- determine if injection of CTM Boost is non-inferior to injection of PRP
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
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
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
PRP Treatment
Each participant randomized to this arm will receive a single injection of Platelet Rich Plasma (PRP).
干预措施: PRP (Biological)
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.
干预措施: CTM Boost (Biological)
结局指标
主要结局
determine if injection of CTM Boost is non-inferior to injection of PRP
时间窗: 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.
次要结局
- Mean Western Ontario Rotator Cuff Index (WORC) Score(at 6 months)
- assessment of superiority of CTM to PRP (if non-inferiority established)/ WORC Score(Each visit up to 24 months)
- assessment of superiority of CTM to PRP (if non-inferiority established) / VAS Pain Scale(Each visit up to 24 months)
- assessment of superiority of CTM to PRP (if non-inferiority established) / SANE(Each visit up to 24 months)
- assessment of superiority of CTM to PRP (if non-inferiority established) / ASES(Each visit up to 24 months)
- assessment of superiority of CTM to PRP (if non-inferiority established) / empty can exercise(Each visit up to 24 months)
- assessment of superiority of CTM to PRP (if non-inferiority established) / side laying external rotation with dumbbell resistance(Each visit up to 24 months)
- assessment of superiority of CTM to PRP (if non-inferiority established) / full can with dumbbell resistance(Each visit up to 24 months)
- assessment of superiority of CTM to PRP (if non-inferiority established) / external rotation at 0 and 90 degrees(Each visit up to 24 months)
- safety of injection of CTM boost compared to PRP(6 months)
- severity of tendinopathy(6 months)
- assessment of superiority of CTM to PRP (if non-inferiority established)(6 months)
研究者
Patrick DeMeo, MD
Professor and Institute Chair of the Department of Orthopaedic Surgery
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)