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.
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
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)
Parallel
Permissive Weight Bearing group
Procedure/SurgeryThe 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 weight as tolerated by pain and comfort. Treatment will take place according to the PROMETHEUS protocol (treatment- and evaluation protocol). The protocol contains a number of weight bearing milestones (e.g. walking with two crutches, walking with two canes, walking with one cane and walking without any walking aids). The treating physiotherapist or physician records the dates that these milestones are reached in the study database.
Restricted Weight Bearing group
Procedure/SurgeryThe 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 weight bearing). Also, any additional advice given to the patient is recorded.
Change in functional outcome as defined by the AOFAS questionnaire
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.
Self-reported function with the Maryland Foot Score
The MFS is an assessment for foot disorders, mainly consisting of the following items: pain, gait, functional activities, and cosmesis. The scale scores have a minimum of 0 points and a maximum of 100 points. A total score of \<50 is considered as poor, 50-74 as fair, 75-89 as good, and 90-100 as excellent.
Activities of Daily Living (ADL) with LEFS
The lower extremity functional scale (LEFS) is a questionnaire containing 20 questions about a person's ability to perform everyday tasks. The LEFS can be used by clinicians as a measure of patients' initial function, ongoing progress, and outcome, as well as to set functional goals. The LEFS can be used to evaluate the functional impairment of a patient with a disorder of one or both lower extremities. It can be used to monitor the patient over time and to evaluate the effectiveness of an intervention. The questionnaire consists of 80 points. The lower the score the greater the disability.
Health Related Quality of Life with EQ-5D-5L
The EuroQol 5-Dimension, 5-Level Health Scale (EQ-5D-5L) is a self-administered questionnaire, which will be completed at baseline together with the cost questionnaire at the same moments (0, 2, 6, 12 weeks and 6 months). Both generic quality of life, as well as utilities, will be derived by means of the EQ-5D-5L, which will be administered both by the patients. The Dutch version of the EQ-5D-5L is chosen because it is a widely used quality of life instrument (nationally and internationally) and it is recommended by the Dutch guidelines.The EQ-5D-5L contains 5 dimensions of health-related quality of life, namely mobility, self-care, daily activities, pain/discomfort and depression/anxiety. Each dimension can be rated at five levels: no problems to major problems. The 5 dimensions can be summed into a health state.
Böhlers angle and posterior facet joint
Radiographic evaluation by a radiologist blinded for treatment allocation will be done at the same time intervals as the scheduled visits to the physician. To see if there is a difference in the alignment of Böhlers angle and posterior facet joint alignment (radiographically measured), a CT-scan will be performed early post-operatively (before first weight bearing) and after 6 months. Differences in the Böhlers angle and posterior joint alignment (Δ = CT6months - CTpost-op.) will be calculated. The normal degree for the Böhler angle varieties between 25° and 40°. An intra-articular step off or gap from less than 2mm of the posterior facet was considered as well-reduced.
Click on the lead sponsor to view all of their trials.
