NCT05894265招募中不适用
Prospective Pilot Study to Determine the Safety and Effectiveness of a Connective Tissue Allograft (Active Matrix) vs. Standard of Care in Arthroscopic Rotator Cuff Repair
The University of Texas Health Science Center, Houston2 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2023年6月14日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Change in Sugaya score as measured by Magnetic Resonance Imaging (MRI)
研究概览
简要总结
The purpose of this study is to see how well the ActiveMatrix® graft works at improving healing and function of the shoulder following rotator cuff repair surgery
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
- Single (Participant)
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
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •1-2 tendon full thickness reparable rotator cuff tendon tear(s)
- •Reparable tear defined as:
- •a tear of the rotator cuff where it is possible to bring the retracted tendon edge back to the greater tuberosity of the humerus under minimal tension.
- •Full-thickness tear defined as:
- •a tear that involves the majority of supraspinatus and less than half of the infraspinatus under minimal tension, with no subscapularis involvement beyond the upper border
- •Failed conservative medical management of the rotator cuff tendon tear defined as: 4-6 weeks of formal physical therapy or guided home exercises and activity modification
- •Have no contraindications or allergies to the treatment administered
- •Have current imaging studies (plain radiographs and MRI exams) of the shoulder to rule out other etiologic diagnoses
- •Able and willing to comply with the post-operative physical therapy and study follow-up schedule
排除标准
- •Prior surgery on the index shoulder within 12 months of enrollment, including Latarjet procedures, superior labral treat from anterior to posterior (SLAP), and (failed) primary rotator cuff surgery,
- •Prior surgery for bone defects requiring bone implantation in the index shoulder,
- •Steroid injection into the index shoulder within 6 weeks of enrollment.
- •Subscapularis tear greater than 1/3 of tendon involvement requiring repair,
- •Calcific tendonitis in the index shoulder,
- •Fatty infiltration of the index shoulder rotator cuff muscle, i.e. Goutallier classification ≥ Grade 3,
- •Contralateral shoulder injury that may interfere with the post-operative rotator cuff repair rehab guidelines,
- •History of advanced osteoarthritis of glenohumeral joint (AC joint can have advanced OA) i.e. Samilson-Prieto classification ≥ Grade 2
- •History of malignant tumor and osseous metastatic disease,
- •History of heterotopic ossification,
- •History of chronic pain disorders (i.e., fibromyalgia),
- •Current substance abuse (drug or alcohol), by the investigator's judgment,
- •For females of child-bearing potential: unable or unwilling to take adequate contraceptive precautions during the study, known to be pregnant at enrollment, breastfeeding an infant at enrollment or during the study, or planning to become pregnant during the study,
- •Currently participating in, or have been recently exited from (within 30 days from enrollment in this study), or plan to enroll in another clinical study for a bone allograft or drug that may impact participation or outcomes of this study,
- •Currently involved in any injury litigation or workers compensation claims,
- •has a condition, disorder or other factor that, in the investigator's opinion, would interfere with study participation.
研究组 & 干预措施
ActiveMatrix® Dosage A
Experimental
干预措施: ActiveMatrix® Dosage A (Other)
ActiveMatrix® Dosage B
Experimental
干预措施: ActiveMatrix® Dosage B (Other)
Saline Injection
Placebo Comparator
干预措施: Saline injection (Procedure)
结局指标
主要结局
Change in Sugaya score as measured by Magnetic Resonance Imaging (MRI)
时间窗: 6 months post surgery , 12 months post surgery
Sugaya classification is a classification system that is used to analyze postoperative rotator cuff tendon integrity
次要结局
- Change in shoulder function as assessed by the American Shoulder and Elbow Surgeons Shoulder Score (ASES)(baseline, 4weeks, 3 months, 6 months 9 months, and 12 months)
- Change in range of motion as assessed by the Passive Range of Motion (PROM) assessment using a goniometer(baseline, 4weeks, 3 months, 6 months 9 months, and 12 months)
- Change in pain intensity as assessed by the Visual Analog Scale (VAS)(baseline, 4weeks, 3 months, 6 months 9 months, and 12 months)
- Change in pain and functional disability as assessed by the Shoulder Pain and Disability Index (SPADI)(baseline, 4weeks, 3 months, 6 months 9 months, and 12 months)
研究者
Eric F Berkman
Assistant Professor
The University of Texas Health Science Center, Houston
研究点 (2)
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