跳至主要内容
临床试验/NCT03315377
NCT03315377进行中(未招募)不适用

Lunatocapitate Fusion Versus Four-corner Fusion for SNAC and SLAC Arthritis. A Randomized Comparison.

Karolinska Institutet2 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2017年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
64
试验地点
2
主要终点
Grip strength

研究概览

简要总结

Hypothesis: Lunate-capitate-fusion (LCF) results in comparable outcome (i.e. not worse) to four-corner-fusion (4CF) for Scaphoid Nonunion Advanced Collapse (SNAC) and Scapholunate Advanced Collapse (SLAC) arthritis regarding functional results (grip strength).

Design: Prospective randomised comparison. Inclusion criteria: SNAC or SLAC arthritis requiring a salvage procedure (grade 2-3).

Exclusion criteria: SNAC or SLAC arthritis grade 4 (panarthritis). Inability to co-operate with the follow-up protocol (language difficulties, severe psychiatric disorder or drug addiction).

详细描述

Surgical method:

Patient will be operated in axially plexus with a dorsal approach through the 3d and 4th extensor tendon compartments. The wrist joint capsule will be opened with a Berger incision. After excision of the scaphoid and preparation of the articular surfaces to be fused, the bones will be fixated with k-wires. Bone autograft from the scaphoid, crista or radius will be used according to the surgeon's preference based on the condition of the fusion surfaces. The wrist be immobilized in a short arm plaster cast until the fusions are radiologically healed after10-12 weeks. The k-wires will be extracted in local anesthesia after another 2-6 weeks.

Sample size:

This study will have a power of 80% to show that the mean grip strength for LC fusion is as least as high as the mean for 4CF (non-inferiority). This assumes that the means for the LC fusion and the 4CF are equal (at 70% of the uninjured side) with a common within-group standard deviation of 14 (Salzman et al. 2015), that a difference of 10% or less is unimportant, that the sample size in the two groups will be 25 and 25, and the alpha (1 tailed) is set at 0,05.Formally, the null hypothesis is that the mean for lunocapitate fusion is 10% lower than the mean for 4CF, and that the study has power of 80,1% to reject this null. Equivalently, the likelihood is 80,1% that the 95% confidence interval for the mean difference will exclude a difference of 10% in favor of 4CF.

We aim to include 60 patients to cover for a certain loss to follow-up.

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

入选标准

  • - SNAC or SLAC arthritis grade 2-3

排除标准

  • SNAC or SLAC arthritis grade 4
  • Inability to cooperate with the follow-up protocol

结局指标

主要结局

Grip strength

时间窗: 1 year postoperatively

Hand grip strength measured with Jamar dynamometer

次要结局

  • DASH score(1 year postoperatively)
  • EQ5D (for analysis of health economy)(1 year postoperatively)
  • Progress of arthritis(1 year postoperatively)
  • Range of motion (ROM)(1 year postoperatively)
  • PRWE score(1 year postoperatively)
  • Complications(1 year postoperatively)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Thorsten Schriever

MD

Karolinska Institutet

研究点 (2)

Loading locations...

相似试验