Dorsal Versus Volar Approach for CapFlex-PIP© Implantation: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Active extension of the PIP joint measured with a goniometer
研究概览
简要总结
The primary objective is to investigate the active extension six months after implantation of the CapFlex-PIP© arthroplasty, comparing the dorsal with the volar approach.
This is a randomized controlled trial including 70 patients with PIP OA indicated for CapFlex arthroplasty.
详细描述
The CapFlex-PIP© implant is a modular gliding surface proximal interphalangeal (PIP) joint prosthesis. For implantation, there are two approaches available: The dorsal central split approach according to Swanson and the volar approach described by Simmen.
Our experiences and data from our prospective registry indicate, that the active extension of the PIP joint is better after the dorsal approach, but sometimes related with hyperextension of the PIP joint and secondary swan-neck deformity. Extension is supposed to be better after the volar approach, but associated with active and passive extension lag. Evidence of theses experiences will assist the surgeon in the preoperative planning to select the appropriate approach according to the patient's needs.
The primary objective is to investigate the active extension six months after implantation of the CapFlex-PIP© arthroplasty, comparing the dorsal with the volar approach.
This is a randomized controlled trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Indication for CapFlex-PIP© arthroplasty
- •Patient aged 18 years and over
- •Informed Consent as documented by signature
排除标准
- •Revision surgery
- •CapFlex-PIP© arthroplasty at the thumb IP joint
- •Major surgery at the same finger (e.g. DIP arthrodesis)
- •Ulnar/radial deviation of the PIP joint > 15°
- •Patients in which a reconstruction of the collateral ligaments has to be performed
- •General medical contraindication to surgery
- •German language barrier to complete the questionnaires
- •Any disease process that would preclude accurate evaluation (e.g. neuromuscular, psychiatric or metabolic disorder)
- •Pregnancy
- •Surgery not planned by Dr. Herren, Dr. Schindele or Dr. Bodmer
- •Legal incompetence
结局指标
主要结局
Active extension of the PIP joint measured with a goniometer
时间窗: 6 months after surgery
次要结局
- Subjective function using the Brief Michigan Hand Questionnaire (briefMHQ)(6 months after surgery)
研究者
Miriam Marks
Dr. phil.
Schulthess Klinik