Permissive Weight Bearing in Displaced Intra-articular Calcaneal Fractures

Официальное название

(Cost-)effectiveness of Permissive Weight Bearing in Surgically Treated Trauma Patients with Displaced Intra-Articular Calcaneal Fractures: a Multicenter, Randomized Controlled Trial

Обзор

The goal of the proposed study is to define the optimal rehabilitation for trauma patients with Displaced Intra-articular Calcaneal Fractures, either Permissive Weight Bearing (PWB) or Restricted Weight Bearing (RWB) regarding functional outcomes, health related quality of life, radiographical differences, cost-effectiveness and complications.

Подробное описание

Rationale: Of all fractures, 1-2% involve the calcaneus. Often surgical treatment is needed. Even after successful treatment it requires long rehabilitation with major impact on daily life and socio-economic aspects. Anatomic surgical restoration does not prevent gait disturbances or persistent foot pain. An adequate rehabilitation program is mandatory to maximize foot stability.

Objective: Evidence showing which rehabilitation protocol is best for both fracture healing and quality of life for patients with Displaced Intra-Articular Calcaneal Fractures (DIACFs) is mostly lacking. This study has the aim to answer the question whether surgically treated patients with DIACFs following the Permissive Weight Bearing protocol (PWB) have better functional outcomes compared to patients with Restricted Weight Bearing protocol after 12 weeks (RWB) measured with the American Orthopaedic Foot \& Ankle Society (AOFAS) Score. The study hypothesizes that patients with DIACFs following the PWB protocol will have a better quality of life (HR-QOL) compared to patients who followed the RWB protocol.

The hypothesis is that there will be lower costs without any radiographic differences for surgically treated (irrespective of technique used) patients with DIACFs following a PWB protocol comparing to the current AO (Arbeitsgemeinschaft für Osteosynthesefragen) standard care: the RWB protocol.

Study design: Multi-center randomized controlled trial

Study population: Presence of surgically (extended lateral, sinus tarsi or percutaneous approach) fixed DIACFs classified as Sanders type II to IV, age 18-67 years (labor force). Patients must be able to understand and follow weight bearing instructions. Patients will only be included after written informed consent is obtained.

Groups (intervention and control): Patients with DIACFs will be randomly allocated to one of the rehabilitation protocols, either PWB or RWB.

Main study parameters/endpoints: Primary objective: functional outcome. Secondary outcomes: quality of life, differences in radiographic parameters, complications, cost effectiveness and differences in surgical techniques.

Nature and extent of the burden: The PWB protocol aims to restore weight bearing faster than RWB protocol in DIACFs. Early postoperative weight bearing poses the risk of increased complications, such as secondary displacement of the fracture or failure of fracture fixation. Previous analysis of this protocol in other lower extremity fractures has shown a safe complication rate, although data from prospective randomized trials in calcaneus fractures are lacking. Follow-up is standardized according to current trauma guidelines, namely at time points 2, 6, 12 weeks and 6 months. The radiation exposure will not be different from standard of care. Therefore, the burden for participants is considered minimal, with no significant health risks.

Вмешательства

• Процедура Permissive Weight Bearing group
  The Permissive Weight Bearing (PWB) protocol allows earlier post-operative permissive weight bearing, where progression of weight bearing is guided by the subjective experience (for example: pain, weight bearing tolerance) of the patient and the clinical expertise of the treating physician and therapist. Patients allocated to the PWB protocol start weight bearing after wound healing is achieved (approximately two weeks after the operation). Consequently, patients are stimulated to bear as much w
• Процедура Restricted Weight Bearing group
  The Restrictive Weight Bearing (RWB) protocol consists of 8 to 12 weeks of postoperative restricted weight (0-10%) bearing, following the current AO Guidelines (7). After 8 weeks of restricted weight bearing, the weight bearing will be increased with 25% per week for 4 weeks. Every time the patient and the treating physical therapist or physician have contact, the weight bearing advice given to the patient at that point in time is recorded (unloaded; partial weight bearing + clarification; full

Первичные конечные точки

• Change in functional outcome as defined by the AOFAS questionnaire [Срок оценки: 0, 2, 6, 12 weeks and 6 months post-surgery.]

Вторичные конечные точки (7)

• Self-reported function with the Maryland Foot Score [Срок оценки: 0, 2, 6, 12 weeks and 6 months post-surgery]
• Activities of Daily Living (ADL) with LEFS [Срок оценки: 0, 2, 6, 12 weeks and 6 months post-surgery]
• Health Related Quality of Life with EQ-5D-5L [Срок оценки: 0, 2, 6, 12 weeks and 6 months post-surgery]
• Böhlers angle and posterior facet joint [Срок оценки: Early postoperative (before first mobilization) and 6 months post-surgery]
• Medical consumption with iMCQ [Срок оценки: 0 weeks and 6 months post-surgery]
• Society costs with iPCQ [Срок оценки: 0 weeks and 6 months post-surgery]
• Occurrence of complications [Срок оценки: 6 and 12 weeks and 6 months post-surgery]

Критерии участия

Критерии включения

• Surgically treated trauma patients with isolated unilateral DIACFs, less than 6 weeks after trauma, Sanders type II-IV (14)
• Age between 18 and 67 years old (labor force)
• Being able to understand the questionnaires and measurement instructions
• Indication for open/closed reduction and internal fixation
• Written Informed Consent

Критерии исключения

• Acute or existing amputation (upper limb, lower limb, feet)
• Open calcaneal fractures (excluding medial wound without compromising surgical approach)
• Bilateral fractures of the lower extremities
• Unable to comply to the PWB protocol due to pre-existing conditions of the arms and legs (e.g. unable to use crotches due to hemiparalysis)
• Severe non-fracture related comorbidity of the lower extremity
• Pre-existent immobility (loss of muscle function of one or both legs)
• Dependent in activities of daily living (e.g. due to dementia, Alzheimer, New York Heart Association class IV angina, heart failure or oxygen-dependent chronic obstructive pulmonary disease)
• Rheumatoid arthritis of the lower extremities
• Severe psychiatric comorbidities that lead to inability to comply with the treatment protocol
• Pathologic fractures (metastasis, secondary osteoporosis)
• Peripheral neuropathy and/or diabetes
• Alcohol- or drug abuse preventing adequate follow-up
• Primary indication for arthrodesis subtalar joint
• Two or more fractures of the upper and/or lower extremities

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

Нидерланды · 11 центров

• Amsterdam University Medical Center — Amsterdam
• Rijnstate Hospital — Arnhem
• Amphia Hospital — Breda
• Catharina Hospital — Eindhoven
• Groene Hart Hospital — Gouda
• Maastricht University Medical Center + — Maastricht
• Radboud University Medical Center — Nijmegen
• Maasstad Hospital — Rotterdam
• … и ещё 3 центра

Публикации

• Verstappen C, Driessen MLS, Kalmet PHS, Brandts L, Kimman M, Edwards M, Hermans E, Poeze M. Permissive weight bearing versus restrictive weight bearing in surgically treated trauma patients with displaced intra-articular calcaneal fractures (the PIONEER study): study protocol for a multicenter randomized controlled trial. Trials. 2024 Nov 18;25(1):778. doi: 10.1186/s13063-024-08617-5. PMID 39558368

Идентификаторы

NCT: NCT05721378 · PIONEER

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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