(Cost-)effectiveness of Permissive Weight Bearing in Surgically Treated Trauma Patients with Displaced Intra-Articular Calcaneal Fractures: a Multicenter, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 115
- 试验地点
- 11
- 主要终点
- Change in functional outcome as defined by the AOFAS questionnaire
研究概览
简要总结
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.
详细描述
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.
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 67 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in functional outcome as defined by the AOFAS questionnaire
时间窗: 0, 2, 6, 12 weeks and 6 months post-surgery.
The American Orthopaedic Foot \& Ankle Society (AOFAS) score is a clinician-based score. It incorporates both subjective and objective information. Patients report their pain, and physicians assess alignment. It is designed for physicians to help standardize the assessment of patients and makes the results of this study comparable with previous data. Scores range from 0 to 100, with healthy foot and ankles receiving 100 points.
次要结局
- Medical consumption with iMCQ(0 weeks and 6 months post-surgery)
- Self-reported function with the Maryland Foot Score(0, 2, 6, 12 weeks and 6 months post-surgery)
- Society costs with iPCQ(0 weeks and 6 months post-surgery)
- Occurrence of complications(6 and 12 weeks and 6 months post-surgery)
- Activities of Daily Living (ADL) with LEFS(0, 2, 6, 12 weeks and 6 months post-surgery)
- Health Related Quality of Life with EQ-5D-5L(0, 2, 6, 12 weeks and 6 months post-surgery)
- Böhlers angle and posterior facet joint(Early postoperative (before first mobilization) and 6 months post-surgery)