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临床试验/NCT06820528
NCT06820528
招募中
不适用

Trapeziectomy and Suture Suspensionplasty for Thumb Carpometacarpal Arthritis - Is In-Clinic Therapy Needed?

Julie Nuelle1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2025年4月17日最近更新:

概览

阶段
不适用
状态
招募中
发起方
Julie Nuelle
入组人数
180
试验地点
1
主要终点
Kapandji Score

概览

简要总结

The study is a randomized, controlled trial to evaluate the efficacy of formal occupational therapy on outcomes following CMC arthroplasty

详细描述

While hand surgeons agree that strength and flexibility exercises are crucial after surgery, there is currently no consensus on whether the benefits of participating in formal hand therapy outweigh the investment required. The financial and time investments required to participate in formal hand therapy can be particularly large in patients living in rural locations, as access to certified hand therapists are often limited. Therefore, a prospective, randomized trial of hand therapy utilization is warranted to explore this phenomenon. The purpose of this clinical trial is to assess the outcomes for post-operative therapy from in-clinic or at-home exercise therapies and analyze costs associated with the different therapies. For this clinical trial patients will be randomized to either in-clinic occupational therapy where patients come into clinic and undergo about 30-60 minutes of occupational therapy 1-2 a week with a physician or at-home exercise therapy where patients are provided instructions in clinic prior to HEP-therapy and have check-ins with physicians at their normal follow-up appointments; each consisting of about 5-10 minutes of exercise at home everyday of the week.

This study is a prospective, randomized, controlled trial to asses and analyze:

  1. The outcomes after trapeziectomy and suture suspensionplasty with in-clinic occupational therapy (OT) and without in-clinic occupational therapy: home exercise program (HEP).
  2. The cost difference between the OT and HEP groups as well as historical control patients that have undergone LRTI for thumb carpometacarpal joint arthritis (Including preoperative, intra-operative, and postoperative costs).

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

  • Patients over the age of 18 years
  • Patients undergoing CMC Arthroplasty
  • Ability to read and write in English
  • Ability to provide informed consent

排除标准

  • Patients undergoing revision CMC arthroplasty
  • Acute traumatic dislocation of the CMC joint as indication for surgery
  • Concomitant treatment of MCP hyperextension

结局指标

主要结局

Kapandji Score

时间窗: 2 weeks, 6 weeks, 12 weeks, 6 months, 1 year

The Kapandji score is a widely used clinical metric for evaluating thumb opposition. It assesses the movement and functional reach of the thumb across into the palm and to the bases of the other fingers. The score ranges from 0 to 10, with each point representing the thumb's ability to touch distinct anatomical landmarks on the hand: from the radial side of the index finger base (score of 1) to the ulnar side of the little finger base (score of 10). This score helps in determining the functional impairment and potential recovery in cases involving thumb or hand injuries, often used in pre- and post-operative assessments.

次要结局

  • Radial Abduction (degrees)(2 weeks, 6 weeks, 12 weeks, 6 months, 1 year)
  • Key Pinch Strength (kg)(2 weeks, 6 weeks, 12 weeks, 6 months, 1 year)
  • PROMIS Upper Extremity(2 weeks, 6 weeks, 12 weeks, 6 months, 1 year)
  • Grip Strength (kg)(2 weeks, 6 weeks, 12 weeks, 6 months, 1 year)
  • PROMIS 29(2 weeks, 6 weeks, 12 weeks, 6 months, 1 year)

研究者

发起方
Julie Nuelle
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Julie Nuelle

Assistant Professor

University of Missouri-Columbia

研究点 (1)

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