A Prospective, Multi-Center, Single-Arm Clinical Trial of the Safety and Effectiveness of the Aptis PRUJ Prosthesis for the Treatment of Patients With Proximal Radial Ulna Joint Disorders.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 84
- 试验地点
- 13
- 主要终点
- Sucess
研究概览
简要总结
A Prospective, Multi-Center, Single-Arm Clinical Trial of the safety and effectiveness of the Aptis PRUJ prosthesis for the treatment of patients with proximal radial ulna joint disorders
详细描述
This is a prospective, multi-center, single-arm clinical trial of the safety and effectiveness of the Aptis PRUJ prosthesis for the treatment of patients with proximal radial ulna joint disorders. A total of 84 patients will be enrolled in this trial with 9 centers participating in the US. The total study duration will be approximately 36 months, with an enrollment period of 12 months, followed by a 24 month follow-up period. Annual visits will continue until the last patient reaches the 2-year post-operative time point.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •In order to be eligible to participate in this study, subjects must meet all of the following criteria:
- •Patient is skeletally mature and under 85 years of age.
- •Patient has a painful, unstable radial head due to degeneration or post-traumatic disabilities presenting pain, crepitation, and decreased motion at the radiohumeral and/or proximal radioulnar joint and is otherwise
- •Patients willing and able to understand and sign the informed consent. In the opinion of the Investigator, the patient has the understanding and willingness to comply with all study requirements including the post-operative rehabilitation and follow-up visits per protocol.
排除标准
- •1. Inadequate bone stock or soft tissue coverage
- •Patients with severe humeral/ulnar arthritis, defined as:
- •Pain at terminal flexion/extension
- •Pain throughout ROM with loss of motion in terminal flexion and/or extension
- •Patients with an allergy to the implant materials
- •Active systemic infection or infection at the site of surgery
- •Physical interference with or by other prostheses during implantation or use
- •Have a Body Mass Index (BMI) greater than 35 kg/m2
- •Have any mental or psychological disorder that would impair the ability to complete the study questionnaires
- •Have significant comorbidities or conditions associated with high-risk for surgical or anesthetic survival (e.g., renal failure, peripheral vascular disease, unstable cardiac disease, poorly controlled diabetes, immunosuppression, etc.)
- •Have any medical condition or other circumstances that might interfere with the ability to return for follow-up visits in the judgment of the Investigator, including any systemic illness, neuromuscular, neurosensory, or musculoskeletal deficiency that would render the subject unable to perform appropriate post-operative rehabilitation
- •Have any condition which, in the judgment of the Investigator, would preclude adequate evaluation of the device's safety and performance
- •Skin, bone, circulatory and/or neurological deficiency at or affecting the implantation site
- •Patients on chronic corticosteroid or non-steroidal anti-inflammatory therapy
- •Women who are pregnant or breast-feeding or are planning to become pregnant during the study.
- •15. Patients with a documented history of uncontrolled diabetes.
- •Patients with known allergies against anesthesia.
- •Patients with a history of or current drug and/or alcohol abuse
- •Patients unlikely to cooperate or are legally incompetent.
- •Patients with legal involvement, including an active claim for workman's compensation, or any other issue that would hinder completion of the two-year follow period.
- •20. Patients who are participating or have participated in any other study involving an investigational drug or device within the past 3 months.
- •Intra-operative Exclusion Criteria
- •Subjects who meet any of the following intra-operative screening criteria will be excluded from participation in this study:
- •A proximal radio ulnar joint that cannot be reduced intraoperatively
- •Inadequate bone quality that would allow for implant placement
- •Not enough radius bone proximally for device implantation
研究组 & 干预措施
Aptis PRUJ Prothesis
Investigational Aptis PRUJ Prothesis treatment
干预措施: Aptis PRUJ Prosthesis (Device)
结局指标
主要结局
Sucess
时间窗: 24 months
A non-inferiority composite primary endpoint for effectiveness and safety, where a subject is considered a success if they meet the following criteria: * Mayo Elbow Performance Score, where success is defined as Good or Excellent at 24 months; and * Absence of radiographic evidence of periprosthetic osteolysis (radiolucent line \>2mm around entire radial stem and ulnar screws), and no screw breakage at 24 months; and * Absence of device-related serious adverse events including any revisions and removals through 24 months
次要结局
- Radiographic(6 weeks, 3 months, 6 months, 12 months, 24 months)
- Health Economic(6 weeks, 3 months, 6 months, 12 months, 24 months)
- Effectiveness(6 weeks, 3 months, 6 months, 12 months, 24 months)