Post Market Confirmatory Interventional Clinical Study of the Integrity Implant System Used for Rotator Cuff Tear Augmentation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 15
- 主要终点
- Re-tear rate after rotator cuff augmentation
研究概览
简要总结
The study design is a prospective, multi-center, single-arm, non-randomized post market clinical follow-up study to confirm the performance, safety and clinical benefit of the Integrity Implant System when used for rotator cuff tear augmentation (with or without repair).
详细描述
The Study Objective is to confirm the performance, safety and clinical benefit of the Integrity Implant System when used for rotator cuff tear augmentation (with or without repair).
The clinical success will be evaluated by absence of rotator cuff re-tear. Performance and clinical benefits will be evaluated by functional outcomes measured using standard scoring systems such as the American Shoulder and Elbow Surgeons Shoulder Score (ASES), Constant-Murley Score (CMS), Patient Satisfaction, EQ-5D-5L, Single Assessment Numeric Evaluation (SANE), Visual Analogue Scale (VAS) and rotator cuff repair outcomes measured using MRI evaluation for repair integrity, quality, tendon tissue thickness and regeneration.
Safety of the Integrity Implant System will be assessed by monitoring the frequency and incidence of adverse events.
The Primary Endpoint shall confirm the Performance of the Integrity Implant System when used for rotator cuff augmentation (with or without repair). Performance will be evaluated by an adequately powered analysis of retear rates seen by MRI at 12-months after surgery.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 18 years of age
- •Able (with assistance from LAR, if necessary) to understand the informed consent process, including regulatory requirements such as HIPAA authorization, and document informed consent prior to completion of any study-related procedures.
- •Able to complete all Patient Reported Outcome Measure (PROM) questionnaires.
- •Fully understands study requirements and able to return for all required follow-up visits and assessments.
- •Able to comply with all post-operative physician prescribed rehabilitation instructions.
- •Index shoulder rotator cuff tendon tear surgical access may be performed using mini-open, single-portal arthroscopic or multi-portal arthroscopic intervention
- •Meets all intended use and indications for use defined within the Integrity Implant System IFUs as applied to rotator cuff tendon tears. These include:
- •Index shoulder rotator cuff tendon tear needs management and protection from injury
- •Index shoulder has no substantial loss of tendon tissue
- •Index shoulder rotator cuff tendon tear footprint allows approximation of soft tissue and fixation of the Integrity Implant to tendon tissue using an Integrity Tissue Tack
- •Index shoulder rotator cuff tendon tear footprint allows fixation of the Integrity Implant to bone using the Integrity Bone Staple
排除标准
- •The subject exclusion criteria are as follows:
- •Medical condition that in the PI's opinion would place the subject at risk or interfere with the study
- •Vulnerable population (prisoners, minors, pregnant women, mentally ill persons and the elderly or any person under any undue pressure from others to participate in the study)
- •Pregnant, breastfeeding, or plans to become pregnant during the study
- •History of poor compliance with medical treatment of any kind
- •Deemed contraindicated for MRI by the PI
- •Previous rotator cuff surgery (any type) on the index shoulder
- •Current instability of the index shoulder
- •Rotator cuff tendon tear is a Massive Cofield Classified Full-Thickness Tear (tear length >5cm)
- •Chondromalacia of index shoulder ≥ Grade 3
- •Fatty infiltration of the index shoulder rotator cuff muscle ≥ Grade 3
- •Insulin dependent Type I Diabetes
- •History of heavy smoking (≥ 1 pack per day) within last 6-months
- •History of auto-immune or immunodeficiency disorders
- •Currently taking immunosuppression medication for other diseases (e.g., transplants or other inflammatory diseases)
- •Oral steroid use in the last 2-months or injectable steroid use in the last 3-months
- •History of cognitive or mental health status that interferes with study participation
- •Poor comprehension of English language
- •Meets one or more of the contraindications defined within the Integrity Implant System IFUs as applied to rotator cuff tendon tears. These include:
- •18.1 Rotator cuff tendon tear is deemed irreparable by the PI
- •18.2 Rotator cuff tendon tear repair requires replacement of damaged tendon
- •18.3 Rotator cuff tendon tear repair requires fixation of soft tissue to adjoining soft tissue
- •18.4 Rotator cuff tendon tear repair requires tendon strength reinforcement
- •18.5 Presence of infection
- •18.6 Any condition which would limit the ability or willingness to restrict activities or follow directions during the healing period
- •18.7 Hypersensitivity to any of the Integrity Implant System components
- •18.8 Inadequate soft tissue support for Integrity Tissue Tack fixation
- •18.9 Inadequate quality of bone for Integrity Bone Staple fixation
研究组 & 干预措施
Integrity Implant System
干预措施: Integrity Implant System (Device)
结局指标
主要结局
Re-tear rate after rotator cuff augmentation
时间窗: 12 months postoperatively
Assessed by MRI evaluation at 12 months post-operatively defined using Sugaya classification system.
次要结局
- The American Shoulder and Elbow Surgeons (ASES) Score(Screening/Pre-Op, 6 weeks, 6-month, 12-month and 24-month Post-operatively)
- Constant-Murley Score (CMS)(Screening/Pre-Op, 6 weeks, 6-month, 12-month and 24-month post-operatively)
- EQ-5D-5L (EuroQol)(Screening/Pre-Op, 6 weeks, 6-month, 12-month and 24-month post-operatively)
- The Single Assessment Numeric Evaluation (SANE) Score(Screening/Pre-Op, 6 weeks, 6-month, 12-month and 24-month post-operatively)