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临床试验/NCT06467669
NCT06467669尚未招募不适用

Predictive Outcomes for Selective Thumb Carpometacarpal Joint Denervation

University of Calgary0 个研究点目标入组 60 人开始时间: 2024年7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
60
主要终点
Pain outcomes from neurectomy

研究概览

简要总结

Background: The thumb (or first) carpometacarpal (CMC) joint is commonly affected by osteoarthritis. Literature has reported a prevalence of 15% in women and 7% in men. First CMC joint osteoarthritis can present with decreased grip strength, pain, instability and inability to engage in routine daily activities. Definitive management is with surgery, however these are associated with known risks and increased weight times for the patient. First CMC joint denervation surgery is supported in the literature as a safe and effective approach to treat pain, strength, and thumb opposition which still allows for definitive surgery to be performed later if the arthritis progressed or if the pain returned later after the surgery.

Objectives: (1) evaluate the effectiveness of the neurectomy in patients with with CMC arthritis with respect to pain relief, functional parameters, and Quick disabilities of the arm, shoulder and hand (QuickDASH) scores; (2) to determine whether pain relief with selective nerve blocks are predictive of the outcome of the combined neurectomy; and (3) to determine whether improvement in grip strength following selective blocks is predictive of final grip strength and outcome following neurectomy.

Methods: Patients referred to the plastic surgery clinic for assessment of symptomatic first CMC joint osteoarthritis will be provided options for standard treatment or denervation procedure. Patients who agree to denervation will undergo local anesthetic block at their initial consult. At their initial consultation as well as at the 2-week, 3-month, 6-month, 12-month and 24-month post-surgical follow-up, patients will complete a QuickDASH, Kapandji score, pain scores, 2-point discrimination and grip/key/3-point strength measurements. The total patient population included in this study will be 60 patients.

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

入选标准

  • Radiographic Eaton stage 2 or 3 1st carpometacarpal joint arthritis
  • Failed medical management, requesting surgical intervention

排除标准

  • Pediatric population
  • Eaton stage 1 or 4
  • Medically unfit for procedure

结局指标

主要结局

Pain outcomes from neurectomy

时间窗: 2 years

Participants will have their pre-operative pain scores compared to their post-operative denervation procedure evaluated with a QuickDASH questionnaire. This form will be completed at pre-operative visits and each follow-up appointment.

次要结局

  • Selective nerve block pain predictions(2 years)
  • Selective nerve block grip strength predictions(2 years)

研究者

申办方类型
Other
责任方
Sponsor

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