Inmobilization With Compression Bandage vs Antebraquial Splint in Distal Radius Fractures

Официальное название

Inmobilization With Compression Bandage vs Antebraquial Splint in Distal Radius Fractures Operated by Internal Fixation With Volar Locking Plate: A Pilot Study

Обзор

The aim of this study is to compare functional and radiological results in two groups of distal radius fractures treated with internal fixation with locking plate, and immobilized with antebrachial splint or compression bandage for 3 weeks.

Подробное описание

The aim of the study is to compare functional and radiological results as well as to evaluate possible complications in distal radius fractures operated by open reduction and internal fixation with volar locking plate in two groups , one treated with immobilization using a forearm cast for 3 weeks and the other with immobilization using a compression bandage for 3 weeks, based on the hypothesis that compression bandage group could obtain better results in the short term, and none of the treatments is superior to the other after 3 or 6 months of evolution, as indicated by some reviewed studies.

Вмешательства

• Устройство Splint inmmobilization
  After internal fixation with volar locking plate, groups of distal radius fractures are inmobilized with a plaster splint of París for 3 weeks
• Устройство Bandage immovilization
  After internal fixation with volar locking plate, groups of distal radius fractures are inmobilized with compressive bandage for 3 weeks

Первичные конечные точки

• Pain in Visual Analogue Scale. [Срок оценки: 1 year]
• Function in Patient Rated Wrist Evaluation Scale. [Срок оценки: 1 year]
• Range Of Motion in Flexion. [Срок оценки: 1 year]
• Range Of Motion in Flexion. [Срок оценки: 1 year]

Вторичные конечные точки (12)

• Function in Disabilities of Arm, Shoulder and Hand Scale. [Срок оценки: 1 year]
• Function in Mayo Wrist Score Scale. [Срок оценки: 1 year]
• Range of motion in Supination. [Срок оценки: 1 year]
• Number of participants with posoperative complications. [Срок оценки: 1 year]
• Number of posoperative Fisiotherapy sessions performed. [Срок оценки: 1 year]
• Time of fracture union in radiographs. [Срок оценки: 12 weeks]
• Number of Instability distal radius fracture Criteria per participant. [Срок оценки: 1 year]
• Grades of Dorsal Displacement in fracture. [Срок оценки: 6 weeks]
• Range of motion in Pronation. [Срок оценки: 1 year]
• Range of motion in Radial Deviation [Срок оценки: 1 year]
• Range of motion in Ulnar deviation. [Срок оценки: 1 year]
• Number of shortening millimeters in fracture. [Срок оценки: 6 weeks]

Критерии участия

Критерии включения

• Patients with type A, B, C fractures of AO classification of distal radius fractures
• Patents aged between 18 and 75 years,
• Patients operated on in the first 3 weeks after the trauma, and independent for the basic activities of daily living

Критерии исключения

• Patients with open fractures
• Patients with mental disorders (dementia, alcoholism, etc.),
• Patient dependent for basic activities of daily living
• Patients with fractures with severe articular and metaphyseal comminution and/or severe soft tissue injuries (type 2R3C3 AO),
• Patients with previous diseases or anatomical alterations in the injured wrist (previous fractures, rheumatoid arthritis, etc.).

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

Простое слепое

Основная цель

Лечение

Центры проведения

Испания · 2 центра

• Hospital Reina Sofía — Córdoba
• Hospital Costa del Sol — Málaga

Публикации

• Delft EAKV, Gelder TGV, Vries R, Vermeulen J, Bloemers FW. Duration of Cast Immobilization in Distal Radial Fractures: A Systematic Review. J Wrist Surg. 2019 Oct;8(5):430-438. doi: 10.1055/s-0039-1683433. Epub 2019 Mar 18. PMID 31579555
• Quadlbauer S, Pezzei C, Jurkowitsch J, Kolmayr B, Keuchel T, Simon D, Hausner T, Leixnering M. Early Rehabilitation of Distal Radius Fractures Stabilized by Volar Locking Plate: A Prospective Randomized Pilot Study. J Wrist Surg. 2017 May;6(2):102-112. doi: 10.1055/s-0036-1587317. Epub 2016 Aug 5. PMID 28428911
• Toemen A, Collocott S, Heiss-Dunlop W. Short Term Outcomes Following Open Reduction Internal Fixation Surgery for a Distal Radius Fracture: 2 Week Versus 4 Week Immobilization. A Retrospective Analysis. Geriatr Orthop Surg Rehabil. 2021 Mar 25;12:21514593211004528. doi: 10.1177/21514593211004528. eCollection 2021. PMID 35186419
• Klein SM, Prantl L, Koller M, Vykoukal J, Dolderer JH, Graf S, Nerlich M, Loibl M, Geis S. Evidence based postoperative treatment of distal radius fractures following internal locking plate fixation. Acta Chir Orthop Traumatol Cech. 2015;82(1):33-40. PMID 25748659
• Lichtman DM, Bindra RR, Boyer MI, Putnam MD, Ring D, Slutsky DJ, Taras JS, Watters WC 3rd, Goldberg MJ, Keith M, Turkelson CM, Wies JL, Haralson RH 3rd, Boyer KM, Hitchcock K, Raymond L; American Academy of Orthopaedic Surgeons. American Academy of Orthopaedic Surgeons clinical practice guideline on: the treatment of distal radius fractures. J Bone Joint Surg Am. 2011 Apr 20;93(8):775-8. doi: 10.2 PMID 21508285
• Valdes K, Naughton N, Michlovitz S. Therapist supervised clinic-based therapy versus instruction in a home program following distal radius fracture: a systematic review. J Hand Ther. 2014 Jul-Sep;27(3):165-73; quiz 174. doi: 10.1016/j.jht.2013.12.010. Epub 2014 Jan 3. PMID 24508093
• Driessens S, Diserens-Chew T, Burton C, Lassig E, Hartley C, McPhail S. A retrospective cohort investigation of active range of motion within one week of open reduction and internal fixation of distal radius fractures. J Hand Ther. 2013 Jul-Sep;26(3):225-30; quiz 231. doi: 10.1016/j.jht.2013.05.002. Epub 2013 Jun 14. PMID 23770202
• Koval K, Haidukewych GJ, Service B, Zirgibel BJ. Controversies in the management of distal radius fractures. J Am Acad Orthop Surg. 2014 Sep;22(9):566-75. doi: 10.5435/JAAOS-22-09-566. PMID 25157038

Идентификаторы

NCT: NCT06019585 · 003may21PIInmovilizacionfxd

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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