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Идёт набор NCT06590701

Scapholunate Ligament Reconstruction: Early Dart Throwing Motion Versus Motion in Anatomical Planes

Без фазы С лечением Scapholunate Ligament Rupture

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: Early dart throwing motion-mobilization.
Кому может быть актуально
Состояния в реестре: Scapholunate Ligament Rupture. 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
Швейцария
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

Patients undergoing scapholunate ligament reconstruction at Balgrist University Hospital are divided into two groups and receive two different types of mobilisation postoperatively. The investigators will compare the outcome (pain, strength, mobility) between the two groups 1 year after the operation.

Подробное описание

The so-called 'dart-throwing motion' (DTM) plane of movement, from radial extension to ulnar flexion, has gained attention as it has been shown to be an important axis of wrist movement during activities of daily living. Further studies have shown that during movement of the intact wrist in the dart throwing plane, most of the movement occurs in the mediocarpal joint, while the proximal row remains relatively immobile.

In scapholunate (SL) ligament reconstruction using the flexor carpi radialis tendon, the SL interval is immobilised using 2 Kirschner wires for 8-10 weeks to relieve the strain on the ligament and allow it to heal. From the 2nd postoperative week, mobilisation is started using DTM mobilisation or mobilisation in the anatomical plane. The aim of the study is to investigate in a randomised trial whether mobilisation in the anatomical plane produces the same postoperative results.

In this project, the investigators will compare two types of mobilisation in the rehabilitation of SL ligament reconstruction. The participants will be randomised to two treatment groups. This procedure therefore corresponds to a risk category A in 'other' clinical trials according to Chapter 4 ClinO.

Вмешательства

  • Другое Early dart throwing motion-mobilization
    We compare two different mobilisations in the rehabilitation of patients following scapholunate ligament reconstruction

Первичные конечные точки

  • Pain in resting position [Срок оценки: Before surgery, 7 weeks after surgery, 11 weeks after surgery, 6 months after surgery, 12 months after surgery]
  • Pain during activity [Срок оценки: Before surgery, 7 weeks after surgery, 11 weeks after surgery, 6 months after surgery, 12 months after surgery]
  • Mobility of the wrist: Flexion [Срок оценки: Before surgery, 7 weeks after surgery, 11 weeks after surgery, 6 months after surgery, 12 months after surgery]
  • Mobility of the wrist: Extension [Срок оценки: Before surgery, 7 weeks after surgery, 11 weeks after surgery, 6 months after surgery, 12 months after surgery]
  • Mobility of the wrist: Ulnar deviation [Срок оценки: Before surgery, 7 weeks after surgery, 11 weeks after surgery, 6 months after surgery, 12 months after surgery]
  • Mobility of the wrist: Pronation [Срок оценки: Before surgery, 7 weeks after surgery, 11 weeks after surgery, 6 months after surgery, 12 months after surgery]
  • Mobility of the wrist: Supination [Срок оценки: Before surgery, 7 weeks after surgery, 11 weeks after surgery, 6 months after surgery, 12 months after surgery]
  • Strength Assessment: Grip Strength [Срок оценки: Before surgery, 11 weeks after surgery, 6 months after surgery, 12 months after surgery]
Вторичные конечные точки (3)
  • Recording ability to work [Срок оценки: Before surgery, 7 weeks after surgery, 11 weeks after surgery, 6 months after surgery, 12 months after surgery]
  • Recording of physical limitations [Срок оценки: Before surgery, 11 weeks after surgery, 6 months after surgery, 12 months after surgery]
  • Recording wrist pain and restrictions [Срок оценки: Before surgery, 11 weeks after surgery, 6 months after surgery, 12 months after surgery]

Критерии участия

Критерии включения

  • SL Ligament reconstruction at Balgrist University Hospital
  • at least 18 years
  • Written informed consent

Критерии исключения

  • Age under 18 years
  • Refusal of participation
  • Pregnancy

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Швейцария · 1 центр
  • Balgrist University Hospital — Zurich

Публикации

  • Crisco JJ, Wilcox BJ, Beckwith JG, Chu JJ, Duhaime AC, Rowson S, Duma SM, Maerlender AC, McAllister TW, Greenwald RM. Head impact exposure in collegiate football players. J Biomech. 2011 Oct 13;44(15):2673-8. doi: 10.1016/j.jbiomech.2011.08.003. Epub 2011 Aug 27. PMID 21872862
  • Werner FW, Green JK, Short WH, Masaoka S. Scaphoid and lunate motion during a wrist dart throw motion. J Hand Surg Am. 2004 May;29(3):418-22. doi: 10.1016/j.jhsa.2004.01.018. PMID 15140483
  • Crisco JJ, Coburn JC, Moore DC, Akelman E, Weiss AC, Wolfe SW. In vivo radiocarpal kinematics and the dart thrower's motion. J Bone Joint Surg Am. 2005 Dec;87(12):2729-2740. doi: 10.2106/JBJS.D.03058. PMID 16322624
  • Moritomo H, Apergis EP, Herzberg G, Werner FW, Wolfe SW, Garcia-Elias M. 2007 IFSSH committee report of wrist biomechanics committee: biomechanics of the so-called dart-throwing motion of the wrist. J Hand Surg Am. 2007 Nov;32(9):1447-53. doi: 10.1016/j.jhsa.2007.08.014. PMID 17996783

Идентификаторы

NCT: NCT06590701 · SL-Reko

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗