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Идёт набор NCT06820528

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

Без фазы С лечением CMC Arthritis Occupational Therapy Hand Arthritis

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Occupational Therapy, Home Exercise Program.
Кому может быть актуально
Состояния в реестре: CMC Arthritis, Occupational Therapy, Hand Arthritis. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

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

Подробное описание

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).

Вмешательства

  • Поведенческое Occupational Therapy
    Formal therapy with a certified hand therapist, weekly for 6 weeks
  • Поведенческое Home Exercise Program
    A booklet on hand exercises to complete following surgery, including range of motion and strengthening exercises

Первичные конечные точки

  • Kapandji Score [Срок оценки: 2 weeks, 6 weeks, 12 weeks, 6 months, 1 year]
Вторичные конечные точки (5)
  • Radial Abduction (degrees) [Срок оценки: 2 weeks, 6 weeks, 12 weeks, 6 months, 1 year]
  • Key Pinch Strength (kg) [Срок оценки: 2 weeks, 6 weeks, 12 weeks, 6 months, 1 year]
  • Grip Strength (kg) [Срок оценки: 2 weeks, 6 weeks, 12 weeks, 6 months, 1 year]
  • PROMIS Upper Extremity [Срок оценки: 2 weeks, 6 weeks, 12 weeks, 6 months, 1 year]
  • PROMIS 29 [Срок оценки: 2 weeks, 6 weeks, 12 weeks, 6 months, 1 year]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • University of Missouri - Columbia — Columbia

Публикации

  • Stepan JG, Rolf L, Zhu E, Brody M, Landau AJ, Calfee RP, Dy CJ. Patient Perspectives after Trapeziectomy and Ligament Reconstruction Tendon Interposition: A Qualitative Analysis. Plast Reconstr Surg. 2022 Dec 1;150(6):1275e-1282e. doi: 10.1097/PRS.0000000000009676. Epub 2022 Sep 20. PMID 36126197
  • Stirton JB, Kagy KL, Mooney ML, Jain MK, Skie M. Early Mobilization After Basal Joint Arthroplasty: Clinical Results. Hand (N Y). 2023 Mar;18(2_suppl):81S-86S. doi: 10.1177/15589447211038699. Epub 2022 Jan 26. PMID 35081799
  • Hutchinson DT, Sueoka S, Wang AA, Tyser AR, Papi-Baker K, Kazmers NH. A Prospective, Randomized Trial of Mobilization Protocols Following Ligament Reconstruction and Tendon Interposition. J Bone Joint Surg Am. 2018 Aug 1;100(15):1275-1280. doi: 10.2106/JBJS.17.01157. PMID 30063589
  • Barret PC, Hackley DT, Lockhart ES, Yu-Shan AA, Bravo CJ, Apel PJ. What Factors Influence Variability in Thumb Carpometacarpal Arthroplasty Care? A Survey of ASSH Members. Hand (N Y). 2025 Jan;20(1):129-135. doi: 10.1177/15589447231188454. Epub 2023 Aug 14. PMID 37575026
  • Barrett PC, Hackley DT, Yu-Shan AA, Shumate TG, Larson KG, Deneault CR, Bravo CJ, Peterman NJ, Apel PJ. Provision of a Home-Based Video-Assisted Therapy Program Is Noninferior to In-Person Hand Therapy After Thumb Carpometacarpal Arthroplasty. J Bone Joint Surg Am. 2024 Apr 17;106(8):674-680. doi: 10.2106/JBJS.23.00597. Epub 2024 Apr 12. PMID 38608035

Идентификаторы

NCT: NCT06820528 · CMC-02062

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗