NCT03734536终止不适用
Prospective Multi-center Study Comparing REGENETEN in Lieu of Standard Arthroscopic Repair of High-grade (>50%) Partial-thickness Tears
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 168
- 试验地点
- 19
- 主要终点
- American Shoulder and Elbow Surgeons (ASES) Score
研究概览
简要总结
The goal of this clinical trial is to demonstrate that REGENETEN is superior to standard repair techniques when surgically treating high-grade (>50%) partial-thickness tears.
详细描述
The objective of this study is to demonstrate arthroscopic surgical treatment of high-grade (>50%) partial-thickness tears using REGENETEN yields statistically superior patient post-operative recovery outcomes, faster return to activities of daily living, and less health care utilization versus standard surgical repair techniques.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients will be considered qualified for enrollment if they meet the following criteria:
- •Male or female ≥18 years
- •High-grade (>50% tendon thickness) partial-thickness tear
- •Failed conservative medical management of the tendon tear defined as:
- •Four (4) to six (6) weeks of formal physical therapy or guided home exercises
- •Activity modification
- •Shoulder injection at the discretion of the surgeon
- •Able to comply with the post-operative physiotherapy and follow-up schedule
- •Able to speak and read English Provide written informed consent
排除标准
- •Any one (1) of the following criteria will disqualify a patient from participation in the study:
- •Prior shoulder surgery on index shoulder within 12 months of enrollment
- •Failed primary rotator cuff surgery of the index shoulder
- •On steroids within 1 month of enrollment
- •Metastatic disease
- •Concomitant surgeries for bone defects requiring bone implantation (Latarjet procedures) or for superior labral tear from anterior to posterior (SLAP)
- •Concomitant biceps tenodesis
- •Rheumatoid arthritis
- •Advanced osteoarthritis
- •Fatty infiltration of the index shoulder rotator cuff muscle ≥ Grade 3
- •Chronic pain disorders (i.e., fibromyalgia)
- •History of insulin dependent diabetes
- •History of heavy smoking (> 1 pack per day) within 6 months of enrollment
- •Currently involved in any injury litigation or workers compensation claims
- •Hypersensitivity to bovine-derived materials Medical or physical condition that, in the opinion of the Investigator, would preclude safe participation in the study
结局指标
主要结局
American Shoulder and Elbow Surgeons (ASES) Score
时间窗: Baseline and 3 months
American Shoulder and Elbow Surgeons (ASES) score at baseline and 3 months following index surgery. ASES is composed of 2 sections containing participant self-reported and clinician assessments. The ASES score is a 0 to 100-point rating based solely on participant responses and is a combination of the participant's shoulder pain rating (VAS Pain) and self-reported ability to perform 10 different activities of daily living (ADLs). A higher score is a better outcome.
次要结局
- American Shoulder and Elbow Surgeons (ASES) Score Weekly Through 3 Months Post-Index Surgery(Baseline, Week 1, Week 2,Week 3,Week 4,Week 5,Week 6,Week 7,Week 8,Week 9,Week 10,Week 11, & Week 12)
- Single Assessment Numeric Value (SANE) Score Weekly Through 3 Months Post-Index Surgery(Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12)
- American Shoulder and Elbow Surgeons Visual Analog Scale (ASES-VAS) Pain Score Weekly Through 3 Months Post-Index Surgery(Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12)
- American Shoulder and Elbow Surgeons (ASES) Score at Baseline, 6 Months, 12 Months, 18 Months and 24 Months(Baseline, 6 months, 12 months, 18 months and 24 months)
- Single Assessment Numeric Value (SANE) Score at Baseline, 6 Months, 12 Months, 18 Months and 24 Months(Baseline, 6 months, 12 months, 18 months and 24 months)
- American Shoulder and Elbow Surgeons Visual Analog Scale (ASES-VAS) Pain Score at Baseline, 6 Months, 12 Months, 18 Months and 24 Months(Baseline, 6 months, 12 months, 18 months and 24 months)
- Constant-Murley Score at Baseline, 3 Months, 6 Months, 12 Months, and 24 Months(Baseline, 3 months, 6 months, 12 months, and 24 months)
- Weekly Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery(Directly after surgery, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12)
- Weekly Non-Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery(Directly after surgery, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12)
- Opioid Use to Treat the Index Shoulder Directly After Surgery, 6 Months, and 12 Months(Directly after surgery, 6 months, and 12 months)
- Non-Opioid Prescription Medication Use to Treat the Index Shoulder Directly After Surgery, 6 Months, and 12 Months(Directly after surgery, 6 months, and 12 months)
- Duration of Shoulder Immobilization(Following index surgery, up to 7 weeks)
- Number of Participants Return to Work Status by Type of Work at 12 Months Post-Index Surgery(Up to 12 months)
- Time to Return to Driving(Following index surgery, up to 139 days)
- Time to Return to Sports(Following index surgery, approximately 1 year)
- Number of Participants With Progression to Full-Thickness Tear at 12 Months(12 months)
- Number of Participants With Progression to Full-Thickness Tear at 24 Months(24 months)
- Number of Participants Percent Filling of Rotator Cuff at 12 Months(12 months)
- Number of Participants Percent Filling of Rotator Cuff at 24 Months(24 months)
- Rotator Cuff Tendon Thickness at 12 Months(12 Months)
- Rotator Cuff Tendon Thickness at 24 Months(24 Months)
- Number of Participants Goutallier Classification of Rotator Cuff at 12 Months(12 months)
- Number of Participants Goutallier Classification of Rotator Cuff at 24 Months(24 months)
- Number of Participants Sugaya Score of Rotator Cuff at 12 Months(12 months)
- Number of Participants Sugaya Score of Rotator Cuff at 24 Months(24 months)
- Number of Participants With Revision Surgery(Following index surgery, up to 24 months)
- Aggregate Health Care Utilization Costs(Following index surgery, up to 12 months)
- Operating Room Time (Index Surgery)(Intra-operative)
- Number of Steroid Injections(Following index surgery, up to 12 months)
- Number of Unscheduled Clinic Visits(Following index surgery, up to 12 months)
- Number of For-Cause Imaging Procedures(Following index surgery, up to 12 months)
- Number of Physiotherapy Sessions(Following index surgery, up to 12 months)
研究者
研究点 (19)
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