Trauma Injury Clinical Trial
— PIONEEROfficial title:
(Cost-)Effectiveness of Permissive Weight Bearing in Surgically Treated Trauma Patients With Displaced Intra-Articular Calcaneal Fractures: a Multicenter, Randomized Controlled Trial
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.
Status | Not yet recruiting |
Enrollment | 60 |
Est. completion date | July 2025 |
Est. primary completion date | February 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 67 Years |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Maastricht University Medical Center |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 0, 2, 6, 12 weeks and 6 months post-surgery. | |
Secondary | 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. | 0, 2, 6, 12 weeks and 6 months post-surgery | |
Secondary | 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. | 0, 2, 6, 12 weeks and 6 months post-surgery | |
Secondary | 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. | 0, 2, 6, 12 weeks and 6 months post-surgery | |
Secondary | 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 (? = 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. |
Early postoperative (before first mobilization) and 6 months post-surgery | |
Secondary | Medical consumption with iMCQ | The iMTA Medical Consumption Questionnaire (iMCQ) measures health care utilization and is based on 29 questions. It is an instrument for measuring medical consumption and is related to frequently occurring contacts with health care providers. The iMCQ is a generic questionnaire. It is therefore not disease specific. The questions ask about health care related appointments patients had in the past period. In case the respondent had no appointments, the score '0' is noted. | 0 weeks and 6 months post-surgery | |
Secondary | Society costs with iPCQ | The iMTA Productivity Cost Questionnaire (iPCQ) measures productivity losses. The questionnaire is based on 12 questions. Questions 1 to 3 give information about the amount of paid work (in hours) and the number of days per week on which the respondent works. The latter provides insight into the average number of hours of work per working day of the respondent. This information is needed to calculate productivity loss costs.
The questions about productivity losses form the following modules: Absenteeism: absenteeism from paid work (questions 4 to 6) Presenteeism: productivity losses during days worked (questions 7 to 9) Productivity loss from unpaid work (questions 10 to 12). After completing the questionnaire the total amount of absenteeism can be calculated by multiplying the number of days absent and the number of hours per working day of the respondent. To calculate the costs of productivity losses, volumes are multiplied by unit cost prices. |
0 weeks and 6 months post-surgery | |
Secondary | Occurrence of complications | Most important complications, such as: wound infection, dislocation, non-union, - failure of osteosynthesis, postoperative arthritis | 6 and 12 weeks and 6 months post-surgery |
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