NCT03378362已完成不适用
A Prospective Study on Pain Relief and Functional Outcome After Partial Denervation of the Wrist
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in Disability of the Arm, Shoulder and Hand score (DASH)
研究概览
简要总结
Prospective study on the effect of partial wrist denervation (ie combined anterior and posterior interosseous neurectomy) on pain relief on functional outcome in patient with wrist osteoarthritis. The impact of psychological factors on postoperative outcome will be studied.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic wrist pain (≥6 months) due to posttraumatic arthritis after distal radius fracture or SLAC/SNAC arthritis or arthritis due to Mb Preiser/Mb Kienböck where surgical unloading of the bone isn't possible.
- •Pain is refractory to nonsurgical management such as bracing, corticosteroid injection, oral analgesics, NSAIDs, physiotherapy.
排除标准
- •Rheumatoid or other inflammatory arthritis.
- •Previous wrist surgery with simultaneous PIN/AIN neurectomy.
- •Simultaneous arthritis or symptomatic instability of the distal radio ulnar (DRU) joint on the ipsilateral side.
- •Inability to co-operate with the follow-up protocol (language difficulties, severe psychiatric disorder, cognitive impairment, drug addiction).
- •Patient's wish for a definite procedure.
研究组 & 干预措施
Partial denervation of the wrist joint
Experimental
Patients will be operated with a partial denervation of the wrist through a single dorsal approach.
干预措施: Partial denervation of the wrist joint (Procedure)
结局指标
主要结局
Change in Disability of the Arm, Shoulder and Hand score (DASH)
时间窗: peroperatively, 3, 6 and 12 months postoperatively
questionnaire
次要结局
- Change in Hospital Anxiety and Depression Scale (HADS)(peroperatively, 3, 6 and 12 months postoperatively)
- Change in range of motion, grip strength(peroperatively, 3, 6 and 12 months postoperatively)
- Change in EQ5D(peroperatively, 3, 6 and 12 months postoperatively)
- Change in Sence Of Coherence -13 (SOC13)(peroperatively, 3, 6 and 12 months postoperatively)
- Change in Patient Related Wrist Evaluation (PRWE)(peroperatively, 3, 6 and 12 months postoperatively)
研究者
Elin Swärd
MD, Principal Investigator
Karolinska Institutet
研究点 (1)
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