Suture Fixation System Versus Tendonous Reconstruction in Thumb Carpometacarpal Arthroplasty: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Overall functionality
研究概览
简要总结
Thumb carpometacarpal (CMC) arthritis affect 1 in 4 females and 1 in 12 males. Patients who fail to respond to conservative treatment may benefit from surgery; however, controversy exists over the most effective surgical technique. A popular technique, ligament reconstruction with tendon interposition (LRTI) involves a trapeziectomy, followed by reconstruction of the palmar oblique ligament using a harvested flexor tendon from the wrist.
We believe that use of a suture fixation system to reconstruct the palmar oblique ligament, instead of harvesting a wrist tendon, may provide a superior repair. The objective of this study is to compare functional outcome measurements among patients who receive CMC arthroplasty using a suture fixation system (investigational group) to those who receive LRTI surgery (control group). We hypothesize that patients in the investigational group will demonstrate superior functionality, compared to patients in the control group.
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
- Double (Participant, Outcomes Assessor)
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
- •Male or female patients aged >
- •Eaton Stage III or IV CMC arthritis
- •Failure to respond to conservative treatment
排除标准
- •Previous surgical interventions on that thumb
- •Upper extremity neurological dysfunction
- •Inability to effectively communicate with the research staff, due to hearing impairment, cognitive impairment, or a language barrier
- •Unwilling or unable to provide written informed consent
研究组 & 干预措施
LRTI
These patients will undergo ligament reconstruction with tendon interposition (LRTI) surgery. They will serve as a control group, against which to compare the investigational surgical technique.
干预措施: Ligament Reconstruction with Tendon Interposition (LRTI) (Procedure)
Suture fixation system
CMC arthroplasty which reconstructs palmar oblique ligament using a suture fixation system.
干预措施: Ligament reconstruction with suture fixation system (Procedure)
Suture fixation system + 2 week immobilization
CMC arthroplasty which reconstructs palmar oblique ligament using a suture fixation system, and with a decreased immobilization time from 6 to 2 weeks post-surgery.
干预措施: Ligament reconstruction with suture fixation system (Procedure)
结局指标
主要结局
Overall functionality
时间窗: Baseline
Functionality will be assessed using the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire, which assesses functionality of the upper extremity, and Short Form 36 (SF-36) health outcomes assessment, which quantifies global functionality (not specific to the upper extremity).
Overall Functionality
时间窗: 24 months
Overall Functionality
时间窗: 6 wks
Overall Functionality
时间窗: 3 mos
Overall Functionality
时间窗: 6 mos
Overall Functionality
时间窗: 12 months
次要结局
- Analog pain scale(Baseline, 2 wks, 6 wks, 3 mos, 6 mos, 12 mos, 24 mos)
- Strength measures(Baseline, 6 wks, 3 mos, 6 mos, 12 mos, 24 mos)
- Range of motion(Baseline, 6 wks, 3 mos, 6 mos, 12 mos, 24 mos)
- Scaphometacarpal distance(Baseline, 6 wks, 3 mos, 6 mos, 12 mos, 24 mos)
- Operative time(Baseline, 6 wks, 3 mos, 6 mos, 12 mos, 24 mos)
研究者
Michael Shuler
Hand and Upper Extremity Specialist
J&M Shuler