Trapeziectomy With Internal Brace Versus Ligament Reconstruction With Tendon Interposition; a Prospective Study
概览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Pinch Strength
概览
简要总结
This study seeks to compare two methods of trapeziectomy for basilar thumb arthritis. The first is trapeziectomy with ligament reconstruction and tendon interposition, which means removing the trapezium bone and filling the void with a tendon graft. This is the most commonly used procedure and the control group. The experimental group is trapeziectomy with suture tape suspension of the 1st metacarpal to the 2nd metacarpal. This is using a device called the InternalBrace, produced by Arthrex.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Patients of Henry Ford Orthopedic Service Line
- •Symptomatic basilar thumb arthritis refractory to conservative management
排除标准
- •Significant medical comorbidity precluding safe surgery, as determined by the operating surgeon. This may include cardiac disease, renal disease, liver disease, pulmonary disease, or heavy substance abuse.
- •Requirement for additional procedures at the 1st carpometacarpal joint, including trapezoid excision-whole or partial-or metacarpal osteotomy. Of note other existing conditions requiring intervention on a separate surgical site such as concomitant carpal tunnel syndrome or trigger fingers will NOT be used as exclusion criteria.
研究组 & 干预措施
Carpometacarpal (CMC) Suture Tape Ligament Reconstruction
Patients in this arm will undergo trapeziectomy with suture tape suspension of the 1st metacarpal to the 2nd metacarpal via Arthrex InternalBrace device. This is the experimental group.
干预措施: Suture Tape Reconstruction (Device)
Carpometacarpal (CMC) Standard Ligament Reconstruction
Patients in this arm are considered the control group and will undergo trapeziectomy with ligament reconstruction and tendon interposition.
结局指标
主要结局
Pinch Strength
时间窗: 6 months post procedure
Pinch Strength measurements
次要结局
- PROMIS-UE(6 months post procedure)
研究者
Charles S Day
Interim Chairman & Medical Director, Professor of Orthopaedic Surgery, Department of Orthopaedic Surgery & Service Line, Wayne State University School of Medicine, Henry Ford Health
Henry Ford Health System