Post-market Clinical Follow-up Study to Provide Safety, Performance and Clinical Benefits Data of the DVR Plating System (Implant and Instrumentation) - A Retrospective Consecutive Series Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 111
- 试验地点
- 1
- 主要终点
- Fracture Healing Based on Clinical Measures and X-rays
研究概览
简要总结
The study is a single-center, retrospective, non-randomized, non-controlled and consecutive series post-market study. The purpose of this study is to confirm safety, performance and clinical benefits of the DVR Plates. The primary objective is the assessment of performance by analyzing fracture healing. The secondary objective is the assessment of safety by recording and analyzing the incidence and frequency of complications and adverse events. Patients' outcomes will also be assessed.
详细描述
The DVR plating system in this study includes the DVR Crosslock Distal Radial Plate, the DVR Volar Rim Plate and the DVR Wrist Plates.
One site will be involved in this study. The aim is to include a total of 112 consecutive series patients treated between 2014 and 2018. All potential study subjects will be required to participate in the Informed Consent Process.
Baseline data from the preop, intraop, immediate post-op and last consultation visit will be available in medical notes and collected retrospectively. During a follow up phone call the patient will be asked to complete a patient questionnaire and a question on his/her wrist function. In addition, any complications since the last consultation visit at the clinic, information about and treatment of the complications will also be collected over the phone.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All subjects must have been implanted with one of the DVR Plates according to the approved indications.
排除标准
- •Off-label use.
- •Cases where there is an active infection.
- •Conditions which tend to retard healing such as, blood supply limitations, previous infections, etc.
- •Insufficient quantity or quality of bone to permit stabilization of the fracture.
- •Conditions that restrict the patient's ability or willingness to follow postoperative instructions during the healing process.
- •Foreign body sensitivity - where material sensitivity is suspected, appropriate tests should be conducted and sensitivity ruled out prior to implantations.
- •Cases where the implant(s) would cross open epiphyseal plates in skeletally immature patients.
- •Cases with malignant primary or metastatic tumors which preclude adequate bone support or screw fixations, unless supplemental fixation or stabilization methods are utilized.
结局指标
主要结局
Fracture Healing Based on Clinical Measures and X-rays
时间窗: Mean time of 3.8 years after the surgery
Fracture healing will be evaluated by x-rays and clinical measures (no pain at fracture site)
次要结局
- Product Safety Based on Complications(Mean time of 3.8 years after surgery)
- Patient's Outcomes Were Also Assessed(Mean time of 3.8 years after surgery)