Connective Tissue Matrix (CTM) Compared to Corticosteroid Injections: A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Raw WORC Score at 3 Month Visit
研究概览
简要总结
The goal of the study is to see which is better at treating patients which rotator cuff tendinopathy (RCT): a single injection of Connective Tissue Matrix boost (CTM) or a steroid shot.
Patients will be randomized (like flipping a coin) to the treatment. Patients and researchers will be blinded (not know) what group the patients are in.
Patients will come back to the study clinic at 6 weeks, 3 months and 6 months after the shot to answer questionnaires, have a physical exam, and complete physical function tests to check their shoulder.
详细描述
CTM vs. Steroid is a double-blind randomized controlled trial. Patients will be randomized to CTM Boost or Kenalog-40 (corticosteroid). Patients will be followed for six months and have three follow-up visits where they will have a physical exam, complete questionnaires, have a physical exam, including physical functional assessments, be screened for adverse events. Data will be collected from their medical chart after each visit.
CTM Boost (CTM Biomedical, Miami, FL) is a tissue allograft derived from decellularized, particulate human placental connective tissue. It is regulated as a minimally-manipulated human cell, tissue, and cellular and tissue-based product (HCT/P) biologic by the FDA and is marketed for homologous use to supplement or replace damaged or inadequate connective tissue. It is implanted via injection into the tissue. CTM Boost is available in a range of volumes. In this study, the 2.0cc volume of CTM Boost will be administered by injection directly into the subacromial space using a 20G needle.
Kenalog-40 is a long-acting corticosteroid injection for intramuscular (into the muscle) or intra-articular (into the joints) use. It may be used to treat many different types of inflammatory conditions. In this study, a 2.0cc dose injection of kenalog-40 will be administered directly into the subacromial space using a 20G needle (for patients randomized to this control arm).
Study Questionnaires are as follows:
- WORC: 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.
- 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.
- VAS: 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).
- ASES: 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
- Functional Assessments: various arm/shoulder exercises with dumbbells, weights or resistance. Time until patient is fatigued and/or number of repetitions will be measured.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 corticosteroid 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 a history of chronic steroid treatment for any medical reason
- •Patients with medical conditions that may affect healing, such as
- •End-stage renal disease
- •Uncontrolled diabetes
- •Peripheral vascular disease
- •Severe and/or systemic immunocompromising conditions such as Lupus or HIV infection
- •Patients who are pregnant or breast feeding
研究组 & 干预措施
Corticosteroid
Kenalog-40 is a long-acting corticosteroid injection for intramuscular (into the muscle) or intra-articular (into the joints) use. It may be used to treat many different types of inflammatory conditions.
In this study, a 2.0cc dose injection of Kenalog-40 will be administered directly into the subacromial space using a 20G needle. 3mL of ropivacaine will be injected along with the steroid (as part of the same injection). Posttreatment pain control (hydrocodone/acetaminophen #20 5/500 mg) will be used.
干预措施: Corticosteroid (Drug)
CTM Boost
TM Boost (CTM Biomedical, Miami, FL) is a decellularized Human Cellular and Tissue Based Allograft (HCT/P) derived from placental connective tissue. It is marketed as an allograft for homologous use to supplement or replace damaged or inadequate connective tissue. It is regulated as a minimally-manipulated biologic by the FDA and is marketed as an allograft for homologous use to supplement or replace damaged or inadequate connective tissue. It is administered applied into the tissue via injection. Participant will undergo a single injection of 2.0cc of the injectable CTM allograft, administered using a 20G needle in the subacromial space. 3mL of ropivacaine will be mixed into the syringe prior to administration of the injection. Posttreatment pain control (hydrocodone/acetaminophen #20 5/500 mg) will be used.
干预措施: celgene (Drug)
结局指标
主要结局
Raw WORC Score at 3 Month Visit
时间窗: 3 Month Visit
The primary outcome will be raw WORC score at the Month 3 visit. WORC is a patient-reported quality of life outcome measure for patients with rotator cuff disorders. The raw score obtained from scoring a completed questionnaire ranges from 0 to 2100, where higher scores indicate poorer quality of life.
次要结局
- WORC Score(Baseline, Week 6, Month 3, Month 6 Visits)
- VAS: The Visual Analogue Scale(Baseline, Week 6, Month 3, Month 6 Visits)
- SANE: The Single Assessment Numeric Evaluation(Baseline, Week 6, Month 3, Month 6 Visits)
- ASES(Baseline, Week 6, Month 3, Month 6 Visits)
- Functional Assessments: Empty can exercise(Baseline, Week 6, Month 3, Month 6 Visits)
- Functional Assessments: External Rotation with Dumbell(Baseline, Week 6, Month 3, Month 6 Visits)
- Functional Assessments: Full can exercise with dumbbell resistance(Baseline, Week 6, Month 3, Month 6 Visits)
- Functional Assessments: External rotation of shoulder at 0 and 90 degrees with Thera-Band resistance(Baseline, Week 6, Month 3, Month 6 Visits)
- Safety Evaluations; Adverse Events; Serious Adverse Events(Week 6, Month 3, Month 6 Visits)
研究者
Sam Akhavan, MD
Principal Investigator
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)