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临床试验/NCT06236204
NCT06236204尚未招募不适用

Arthroscopic Scapholunate Ligament Reconstruction, Volar and Dorsal Reconstruction, as Treatment for Dysfunction of the Scapholunate Joint With Insufficiency of the Scapholunate Ligament and Secondary Stabilizers

Regionaal Ziekenhuis Heilig Hart Tienen2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年2月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
20
试验地点
2
主要终点
Disabilities of the Arm, Shoulder and Hand score

研究概览

简要总结

Arthroscopical reconstruction of the volar and dorsal part of the scapholunate ligament as treatment for complete scapholunate ligament injury, but reducible carpal malalignment.

This prospective study aims to evaluate the clinical and functional outcome of this technique on the short and middle term

详细描述

Classical arthroscopic techniques for scapholunate instability consist of debridement, thermal shrinkage, and percutaneous pinning. Good results are obtained in acute lesions or in chronic partial tears, but they are less predictable when the lesion is complete, because of the poor healing capacity of the scapholunate ligament and because it is not possible to perform an anatomic ligamentous reconstruction with these techniques. Open techniques are thus required for reconstruction, but they damage the soft tissues. Corella et al. published a description and cadaver study of an arthroscopic ligamentoplasty, trying to combine the advantages of arthroscopic techniques (minimally invasive surgery) and open techniques (reconstruction of the ligament). With this approach, it is possible to reconstruct the dorsal scapholunate ligament and the secondary stabilizers while causing minimal damage to the soft tissues and avoiding injury to the posterior interosseous nerve and detachment of the dorsal intercarpal ligament. Arthroscopic scapholunate volar and dorsal ligament reconstruction achieves an anatomic reconstruction to provide a strong construct for early mobilization.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Scapholunate dysfunction, complete irrepairable lesion of the SL ligament and the secondary stabilizers (RSC-LRL-SRL) EWAS stage 4-5, no arthritis, with reducible malalignment
  • 18 - 65 years

排除标准

  • - associated lesions, fractures
  • neurological disorder affecting the upper limb, history of wrist lesion involving the same wrist, dementia, substance abuse, severe psychiatric disorder and previous injured contralateral wrist

结局指标

主要结局

Disabilities of the Arm, Shoulder and Hand score

时间窗: postoperative 12 months

function score (0 is best -100 is worst)

passive and active range of motion (degrees) operated and contralateral side

时间窗: postoperative 12 months

flexion, extension, ulnar and radial deviation

grip strength (kg) operated and contralateral side

时间窗: postoperative 12 months

dynamometer (kg)

pain (visual analogue scale)

时间窗: postoperative 12 months

Visual analogue Scale (0 no pain -10 cm worst pain)

次要结局

  • patient satisfaction after treatment(postoperative 12 months)
  • complications(postoperative 12 months)
  • scapholunate distance, carpal angles(postoperative 12 months)
  • arthroscopical assessment of the scapholunate stability(intraoperative)

研究者

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

Goorens Chul Ki

orthopaedic surgeon, principal investigator

Regionaal Ziekenhuis Heilig Hart Tienen

研究点 (2)

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