A Prospective, Multi-Center, Single-Arm Study to Assess Clinical Outcomes In Primary Open or Mini-Open Rotator Cuff Repair Using Conexa Graft Reinforcement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 61
- 试验地点
- 12
- 主要终点
- Adjusted Constant-Murley Score
研究概览
简要总结
The purpose of this study is to evaluate patient shoulder functional outcomes following rotator cuff repairs reinforced with a surgical mesh.
详细描述
Conexa is a surgical mesh derived from porcine dermis and processed to produce an acellular dermal matrix. It is designed to perform as a surgical mesh for use as a soft tissue patch to reinforce soft tissue where weaknesses exist and for the surgical repair of damaged or ruptured soft tissue membranes. The purpose of this post-market clinical study is to collect safety and efficacy data when Conexa is used to repair torn tendons of the rotator cuff. Conexa will be used in accordance with its labeling for this clinical study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient:
- •is an adult male or female between the ages of 40-70 years old;
- •has repairable primary large retracted two-tendon rotator cuff tears measuring from 3 cm to 5 cm;
- •requires surgical repair of single rotator cuff (i.e. one limb);
- •has movement of the non-operative arm defined as shoulder elevation of equal to or greater than 90 degrees and is able to perform postoperative exercises;
- •is able to return for all scheduled and required study visits;
- •is able to provide written informed consent for study participation.
排除标准
- •The patient:
- •has irreparable large rotator cuff tears that are found intra-operatively. Note: irreparable is defined by the inability to approximate the tendon to the tuberosity without tension;
- •has a rotator cuff tear < 3cm (measured intra-operatively);
- •has a rotator cuff tear > 5cm (measured intra-operatively);
- •has a rotator cuff tear where the subscapularis tendon is disrupted/requires repair;
- •has grade 3 or 4 fatty infiltration of the rotator cuff;
- •has had prior surgical repair to the affected shoulder;
- •is American Society of Anesthesiologists (ASA) Class 4 or 5 (See Appendix I);
- •is a tobacco user; unless tobacco free 6 months prior to surgery and willing to remain tobacco free for the duration of the study.
- •has lower limb injuries requiring walking assist devices such as crutches and walkers;
- •has a known collagen disorder, including systemic lupus erythematous (SLE), rheumatoid arthritis (RA), polymyositis, scleroderma, ankylosing spondylitis, dermatomyositis, osteogenesis imperfecta or the inherited disorders of Sjogren, Larsen, Raynaud, Ehlers-Danlos or Marfan syndrome.
- •has obstacles that pose an inordinately high surgical risk, in the judgment of the certified surgeon;
- •has co-morbid factors which predispose to postoperative infection, such as insulin dependent diabetes, chronic steroid use, malnourishment, cancer, or co-existent infection;
- •has a history of alcohol abuse, illicit drug use, significant mental illness, physical dependence to any opioid, or drug abuse or addiction;
- •is enrolled or plans to enroll in another clinical trial during this study that would affect the patient's safety or results of this trial;
- •has any of the conditions identified within the labeled contraindications, i.e. sensitivity to porcine derived products or polysorbate.
- •has an inability to have a closed MRI conducted.
- •needs a re-operation for a re-tear of the rotator cuff.
结局指标
主要结局
Adjusted Constant-Murley Score
时间窗: baseline, post-op months 6, 12, and 24
The Constant-Murley Shoulder Score is a 100-point functional shoulder assessment tool in which higher scores reflect increased function. The subjective variables are pain (15 points) and function (Activities of Daily Living - sleep, work, recreation/sport) (20 points), for a total of 35 points. The objective variables are active range of motion (clinician assessment) (40 points) and strength (25 points), for a total of 65 points (Stiller \& Uhl, 2005).
American Shoulder and Elbow Score (ASES)
时间窗: baseline, post-op months 3, 6, 12, and 24
The ASES evaluation generally has a patient self-evaluation section and a physician assessment section. The patient self-evaluation section of the form contains visual analog scales for pain, instability, an activities of daily living (ADL) questionnaire. The physician assessment section includes an area to collect demographic information and assesses range of motion, specific physical signs, strength, and stability. A shoulder score can be derived from the visual analogue scale score for pain (50%) and the cumulative activities of daily living score (50%) (Richards, Bigliani, Gartsman, Iannotti, \& Zuckerman, 1994). The ASES evaluation has a total of 100 points possible; with 100 being the best possible outcome, and 0 being the worst.
Simple Shoulder Test (SST)
时间窗: baseline, post-op months 3, 6, 12, and 24
The Simple Shoulder Test (SST): a series of 12 "yes" or "no" questions the patient answers about the function of the involved shoulder; 2 questions relate to pain, 7 questions relate to function and 3 questions relate to range of motion. The answers to these questions (yes = 1, no = 0) provides a standardized way of recording the function of a shoulder before and after treatment (McClure \& Michener, 2003). A score of 12 on the Simple Shoulder test represents the best possible outcome, while a score of 0 represents the worst possible outcome.
次要结局
- Rotator Cuff Re-tear Evaluation(Post-op months 6 and 12)
- Isometric Strength(baseline, post-op months 6, 12, and 24)