Hand Ligament Reconstructions With Knee Collateral Ligament Allografts
试验速览
- 阶段
- 不适用
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Change from baseline in functional outcome, as measured by the quick Disabilities of the Arm, Shoulder and Hand (qDASH) questionnaire
研究概览
简要总结
The purpose of this study is to review the clinical outcomes following hand ligament reconstruction surgery using allograft (cadaveric) knee collateral ligaments. Currently, there is no standard procedure or devices used for hand ligament reconstruction surgery, although most techniques use some form of autograft (patients' own tissue) for the reconstruction. We believe that the use of allograft ligaments in reconstruction may eliminate the pain associated with procuring the patients' own tissue for the procedure, and prove to be a viable and preferred alternative to the multiple techniques currently used.
The main procedures of this study include wrist and hand ligament reconstruction surgery (for wrist scapholunate (SL) ligaments, thumb ulnar collateral ligaments (UCL), and finger proximal interphalangeal (PIP) joint collateral ligaments) using allograft ligament, and subsequent follow up appointments where measurements and questionnaires will be completed to evaluate how hand function is doing after surgery.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Have symptomatic injuries to either their finger PIP collateral ligaments, thumb UCL ligaments, or wrist SL ligaments and have failed non-operative management for the above ligament injuries (thus eligible for operative reconstruction)
- •Age over 18 years
排除标准
- •Presence of any other current injury in that limb
- •Presence of advanced arthrosis in that limb
- •Presence of fixed joint deformity in that limb
- •Presence of instability in that limb due to bony or articular instability
- •Presence of instability in that limb due to inflammatory arthrosis
- •Is under 18 years of age
- •Lacks the capacity to consent
结局指标
主要结局
Change from baseline in functional outcome, as measured by the quick Disabilities of the Arm, Shoulder and Hand (qDASH) questionnaire
时间窗: Baseline, post-surgery 6 week, post-surgery 6 month, post-surgery 1 year
The qDASH questionnaire asks about symptoms of upper extremity disability as well as the ability to perform certain activities. It generates a score from 0 to 100, with higher scores indicating greater severity of disability.
Change from baseline in pain, as measured by the Visual Analog Scale (VAS)
时间窗: Baseline, post-surgery 6 week, post-surgery 6 month, post-surgery 1 year
The VAS generates a scale from 0 to 100 with 0 indicating no pain and higher scores indicating greater pain.
Change from baseline in key pinch strength, as measured with a pinch gauge.
时间窗: Baseline, post-surgery 6 week, post-surgery 6 month, post-surgery 1 year
A pinch gauge is a device that measures key pinch strength in units of pounds or Newtons.
Change from baseline in grip strength, as measured with a Jamar hand dynamometer.
时间窗: Baseline, post-surgery 6 week, post-surgery 6 month, post-surgery 1 year
A Jamar hand dynamometer is a device that measures grip strength in units of pounds or Newtons.
Change from baseline in wrist and finger range of motion angles.
时间窗: Baseline, post-surgery 6 week, post-surgery 6 month, post-surgery 1 year
Range of motion to be assessed includes wrist extension, wrist flexion, wrist ulnar deviation, wrist radial deviation, finger proximal interphalangeal joint flexion and extension, thumb metacarpophalangeal joint flexion and extension, thumb abduction and adduction.
Change from baseline in wrist and finger radiographs.
时间窗: Baseline, post-surgery 6 week, post-surgery 6 month, post-surgery 1 year
Radiographic images obtained can help indicate the success of surgery by demonstrating joint stability.
次要结局
未报告次要终点
研究者
David Kulber, MD
Director of Hand and Upper Extremity Surgery
Cedars-Sinai Medical Center