A Prospective Randomized Trial Comparing Standard Ligament Reconstruction Tendon Interposition (LRTI) VS Ligament Reconstruction Tendon Interposition (LRTI) With an Interference Screw for Thumb Carpometacarpal Arthritis - Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Subsidence of CMC joint
研究概览
简要总结
A Prospective Randomized Trial Comparing Standard Ligament Reconstruction Tendon Interposition (LRTI) VS Ligament Reconstruction Tendon Interposition (LRTI) with an interference screw for thumb carpometacarpal arthritis
详细描述
This study will be a prospective randomized trial done in a single academic center. The patients who meet the inclusion criteria and agree to participate in the trial will be scheduled for a first CMC joint procedure. The procedure, standard LRTI or LRTI with a biotenodesis screw, will be allocated in a randomized fashion in the operating room using a sealed opaque envelope. After the surgery the patient will be placed in a spica splint for 1-2 weeks. Following suture removal, a thumb spica cast will be applied for immobilization for a total of 6 weeks of post-operative immobilisation.
The potential population for this study will include all patients with first carpometacarpal joint arthritis that have failed a conservative treatment. The primary outcome will be the thumb subsidence measured as the percentage of trapezial height, which correlates with stability. Subsidence will be measured on stress x-ray under a standard pinch load. Secondary outcomes will be function measured in 4 different ways: the range of motion compared to the contralateral side, pinch and grip strength compared to the other side, the Disabilities of the Arm Shoulder and Hand (DASH) score and the pain score on a visual analogue scale.
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
- •First CMC primary osteoarthritis refractory to conservative treatment
- •Patient >age 18
- •Able to read and understand English
- •Available for 2 year follow up
排除标准
- •Inflammatory Arthritis
- •Active infection in the first CMC joint
- •Concomitant neuropathy
- •Previous surgical procedure on the thumb
- •Active or status post CRPS
- •Severe ¨Z ¨deformity that requires palmar plate advancement
- •Unwilling to participate in a research project
- •Contralateral first CMC joint surgery
研究组 & 干预措施
LRTI without a Biotenodesis Screw
Ligament Reconstruction Tendon Interposition without a Biotenodesis Screw
干预措施: LRTI (Procedure)
LRTI with Biotenodesis Screw
Ligament Reconstruction Tendon Interposition with Biotenodesis Screw
干预措施: Biotenodesis Screw (Device)
LRTI with Biotenodesis Screw
Ligament Reconstruction Tendon Interposition with Biotenodesis Screw
干预措施: LRTI (Procedure)
结局指标
主要结局
Subsidence of CMC joint
时间窗: 6 weeks, 3 months, 6 months, 1 year, 2 years
Measurement of trapezial height as a percentage of pre-operative height
次要结局
- Opposition as measured by goniometer(Baseline, 3 months, 6 months, 1 year, 2 years)
- Radial abduction as measured by goniometer(Baseline, 3 months, 6 months, 1 year, 2 years)
- Palmar abduction as measured by goniometer(Baseline, 3 months, 6 months, 1 year, 2 years)
- Pain score on the visual analogue scale(Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years)
- DASH questionnaire score(Baseline, 6 weeks, 3 months, 6 months, 1 year, 2 years)
- Grip strength as measured by dynamometer(Baseline, 3 months, 6 months, 1 year, 2 years)
- EQ-5D Health Questionnaire Score(Baseline, 6 weeks, 3 months, 6 months, 1 year, 2 years)
- Pinch strength as measured by dynamometer(Baseline, 3 months, 6 months, 1 year, 2 years)
研究者
Andrew Trenholm
Orthopaedic Surgeon
Nova Scotia Health Authority