A Single Blinded, Multi-center, Randomized, Controlled, Pilot Study to Evaluate the Safety and Performance of Augment™ Rotator Cuff for Primary Surgical Treatment of Full Thickness Rotator Cuff Tears
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 6
- 主要终点
- Magnetic Resonance Imaging (MRI)
研究概览
简要总结
Study Purpose: To evaluate the safety and performance of Augment Rotator Cuff as a primary surgical treatment for full thickness rotator cuff tears. The hypothesis is that Augment Rotator Cuff will be easy to deliver as an inter-positional graft placed between the rotator cuff tendon and the humeral head providing further enhanced tendon to bone healing without adding any additional safety risk to the patient.
Study Rationale: To evaluate the safety and performance Augment™ Rotator Cuff in surgical intervention of a torn rotator cuff and to obtain preliminary data to support the rationale for a subsequent pivotal clinical trial.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject has a repairable rotator cuff tear with an estimated full thickness size of ≥ 2 cm to < 5 cm confirmed with diagnostic MRI in AP or ML dimension
- •The subject is independent, ambulatory, and can comply with all post-operative evaluations and visits
- •The subject is at least twenty one (21) years of age and considered to be skeletally mature.
排除标准
- •The subject has undergone previous rotator cuff repair surgery to the affected shoulder
- •The subject has a partial thickness rotator cuff tear
- •The subject requires a concomitant subscapularis repair
- •The subject requires a concomitant labral repair
- •The subject has an irreparable rotator cuff tear
- •The subject has an allergy to yeast-derived products or a known bovine collagen allergy
- •The subject has implanted metallic devices (cardiac pacemakers, insulin pumps, and nerve stimulators), medically implanted clips or other electronically, magnetically or mechanically activated implants that would contraindicate undergoing an MRI scan of the shoulder
- •The subject has tested positive or has been treated for a malignancy in the past or is suspected of having a malignancy or is currently undergoing radiation or chemotherapy treatment for a malignancy anywhere in the body, whether adjacent to or distant from the proposed Augment Rotator Cuff implantation site
- •The subject's condition represents a worker's compensation case
- •The subject is currently involved in a health-related litigation procedure
- •The subject is pregnant or able to become pregnant but not practicing a medically-accepted form of birth control, and/or intending to become pregnant during this study period
研究组 & 干预措施
Group 1
Standard Suture Repair + Augment Rotator Cuff
干预措施: Augment Rotator Cuff (Device)
Group 2
Standard Suture Repair
干预措施: Standard Suture Repair (Procedure)
结局指标
主要结局
Magnetic Resonance Imaging (MRI)
时间窗: 24 weeks
The scans were evaluated for degree of re-tears (no re-tears, partial or complete re-tear) by an independent radiologist to assess device integrity and surgical treatment of the rotator cuff tear.
Disabilities of the Arm, Shoulder and Hand (DASH)
时间窗: 24 weeks
a self-report questionnaire evaluates the subjects' symptoms and ability to perform activities of daily living, athletic activities and homemaking/work activities. The DASH consists mainly of a 30-item disability/symptom scale, scored 0 (no disability) to 100
Western Ontario Rotator Cuff Index (WORC)
时间窗: 24 weeks
a self-report questionnaire specifically designed to evaluate disability in persons with pathology of the rotator cuff. Each question uses a visual analogue scale (VAS) - which is a straight line, representing a 100-point scale, ranging from 0-100, with a higher score representing lower quality of life.
Constant-Murley Shoulder Outcome Score (CSS)
时间窗: 24 weeks
to assess the shoulder and determine at minimum the range of motion (ROM), external rotation and internal rotation, and power score. The Constant-Murley score (CMS) is a 100-points scale composed of a number of individual parameters. These parameters define the level of pain and the ability to carry out the normal daily activities of the patient. The test is divided into four subscales: pain (15 points), activities of daily living (20 points), strength (25 points) and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder (40 points). The higher the score, the higher the quality of the function.
次要结局
未报告次要终点