PMCF Study to Provide Safety, Performance and Clinical Benefits Data of the Comprehensive Segmental Revision System (SRS) Regenerex Tissue Attachment Augments - A Retrospective Enrollment and Prospective Follow-up Consecutive Series Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Kaplan Meier Implant Survivorship
研究概览
简要总结
The objective of this retrospective and prospective consecutive series data collection is to confirm safety, performance, and clinical benefits of the Comprehensive SRS Regenerex Tissue Attachment Augments when used for limb salvage arthroplasty.
详细描述
Consecutive subjects implanted with Comprehensive SRS Regenerex Tissue Attachment Augments according to the approved indications, with the longest-term follow-up possible, will be identified and invited to participate in the study.
The primary objective is the assessment of safety by analyzing implant survivorship. This will be established by recording the incidence and frequency of revisions, complications, and adverse events. Relation of the events to the implant and/or procedure should be specified.
The study will include one site. There will be a maximum of 103 patients enrolled in the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Patient must be 18 years of age or older.
- •Patient must be willing and able to follow directions.
- •The Comprehensive Segmental Revision System was used in cases of:
- •Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
- •Revision where other devices or treatments have failed.
- •Correction of functional deformity.
- •Oncology applications including bone loss due to tumor resection.
- •Proximal or total humeral replacement, for: Treatment of acute or chronic fractures with humeral head (shoulder) involvement, which are unmanageable using other treatment methods.
- •Distal or total humeral replacement for: Treatment of acute or chronic fractures with humeral epicondyle (elbow) involvement, which are unmanageable using other treatment methods.
- •Biomet Comprehensive Segmental Revision System was used in a reverse application in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff for proximal humeral replacement. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary.
- •The Comprehensive Segmental Revision System was used with bone cement in distal humeral and total humeral applications.
- •Regenerex Tissue Attachment Augments were used in combination with the Comprehensive Segmental Revision System
排除标准
- •Absolute contraindications:
- •Infection
- •Osteomyelitis
- •Patient is a prisoner
- •Patient is a current alcohol or drug abuser
- •Patient has a psychiatric illness or cognitive deficit that will not allow for proper informed consent
- •Patient is unwilling to consent
- •Relative contraindications:
- •Uncooperative patient or patient with neurologic disorders who is incapable of following directions
- •Osteoporosis
- •Metabolic disorders which may impair bone formation
- •Osteomalacia
- •Distant foci of infections which may spread to the implant site
- •Vascular insufficiency, muscular atrophy, or neuromuscular disease
- •The Comprehensive Segmental Revision System was used in a reverse shoulder application in patients receiving radiation therapy
- •The Comprehensive Segmental Revision System was used without bone cement in distal humeral and total humeral applications.
- •Regenerex Tissue Attachment Augments weren't used during the patient's surgery
结局指标
主要结局
Kaplan Meier Implant Survivorship
时间窗: Up to 10 Years
This will be established by recording the incidence and frequency of device revisions. Kaplan-Meier survival analysis is a statistical method that estimates survival rates over time and accounts for factors that can affect implant survival.
Safety Assessement
时间窗: Up to 10 Years
This will be established by recording the incidence and frequency of complications and adverse events. Relation of the events to the implant and/or procedure will be specified.
次要结局
- Assessment of performance and clinical benefits by recording patient reported QuickDASH(Up to 10 Years)