A Prospective Randomized Clinical Trial Comparing Mini TightRope Suspensionplasty With Ligament Reconstruction and Tendon Interposition (LRTI) for the Surgical Treatment of Thumb Carpometacarpal Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- quick DASH score
研究概览
简要总结
Thumb carpometacarpal osteoarthritis is a common cause of pain, weakness and functional disability. Trapeziectomy with ligament reconstruction and tendon interposition (LRTI) is considered a standard surgical procedure, whereas Mini TightRope suspensionplasty has been introduced to facilitate earlier mobilization while maintaining first metacarpal stability.
This prospective randomized single-center clinical trial compares Mini TightRope suspensionplasty with LRTI in patients with symptomatic Eaton-Littler stage II-IV thumb carpometacarpal osteoarthritis. Fifty patients were randomized in a 1:1 ratio to undergo either Mini TightRope suspensionplasty or LRTI. Clinical and radiographic outcomes were evaluated preoperatively and at 3 months, 6 months, 1 year and 2 years postoperatively.
The primary outcome was the Quick Disabilities of the Arm, Shoulder and Hand (qDASH) score at 2 years. Secondary outcomes included pain, thumb opposition, grip strength, pinch strength, operative time, radiographic preservation of metacarpal height and complications.
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
- •Symptomatic thumb carpometacarpal osteoarthritis
- •Eaton-Littler stage II-IV
- •Failure of at least six months of conservative treatment
- •Ability to provide informed consent
- •Ability to comply with follow-up
排除标准
- •Inflammatory arthritis
- •Previous thumb surgery
- •Concomitant carpal pathology
- •Incomplete radiographs
- •Inability to comply with rehabilitation
研究组 & 干预措施
Mini TightRope Suspensionplasty
Complete trapeziectomy followed by suspension of the first metacarpal using the Arthrex Mini TightRope suture-button system.
干预措施: Mini tightrope suspensionplasty (Procedure)
Ligament Reconstruction and Tendon Interposition (LRTI)
Complete trapeziectomy with ligament reconstruction using the flexor carpi radialis tendon and tendon interposition.
干预措施: Ligament Reconstruction and Tendon Interposition (LRTI) (Procedure)
结局指标
主要结局
quick DASH score
时间窗: 2 years
Quick Disabilities of the Arm, Shoulder and Hand score measured preoperatively and during follow-up, with the primary endpoint at two years.
次要结局
- VAS score(2 years)
- Kapandji score(2 years)
- Grip strength(2 years)
- Trapeziometacarpal Index(2 years)
研究者
Theodoros Mylonas
Resident of Orthopaedics
University of Thessaly