NCT04348253招募中不适用
Reconstruction of Chronic Scapholunate Ligament Injuries in the Wrist: A Randomized Controlled Trial Comparing The Berger Capsulodesis and Three-Ligament-Tenodesis (3LT)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- The Disabilities of the Arm, Shoulder and Hand Score (QuickDash)
研究概览
简要总结
Comparison of two surgical techniques commonly used for reconstruction of the scapholunate (SL) ligament. A randomized multicenter study.
详细描述
This multicentre study aim to compare two surgical techniques commonly used for reconstruction of the scapholunate (SL) ligament. The investigators compare patient reported, clinical and radiological outcomes up to 10 years after treatment of complete dynamic or static but reducible SL ligament lesions. The participants are randomized to two treatments. Effect parameters before and after intervention are compared between groups.
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)
盲法说明
Scares are identical. Patient and examiner are blinded
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-60 years (both included).
- •Symptomatic SL instability (VAS score ³3, QDASH score ³ 20).
- •> 6 weeks since symptomatic hand trauma (chronic SL lesions).
- •SL gapping on radiographic stress views or SL gapping (³2mm) on static PA views.
- •Complete SL ligament lesion confirmed by wrist arthroscopy
排除标准
- •Geissler grade 1-3 SLL injury (evaluated by arthroscopy).
- •Concomitant complete luno-triquetral (LT) ligament injury (evaluated by arthroscopy).
- •Lesion of TFCC leading to DRUJ instability (evaluated by arthroscopy).
- •Radiocarpal or midcarpal arthritis evaluated by arthroscopy.
- •Previous fracture in carpus or intraarticular radius fracture with step off (³2 mm), disposing to posttraumatic arthritis.
- •Adverse effects after extra articular radial fractures (dorsal angulation ³10 grader).
- •Peroperatively non-reducible scaphoid flexion/SL gap.
- •Terminal illness or severe medical illness: ASA score higher than or equal to 3.
结局指标
主要结局
The Disabilities of the Arm, Shoulder and Hand Score (QuickDash)
时间窗: At all follow-ups (0-10 years)
points
次要结局
- Wrist motion(At all follow-ups (0-10 years))
- Grip-strength(At all follow-ups (0-10 years))
- SL angle(At all follow-ups (0-10 years))
- The Patient-Rated Wrist Evaluation (PRWE) score(At all follow-ups (0-10 years))
研究者
研究点 (4)
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