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Treatment Arms for Randomization
Restrictive treatment: Immobilization in a cast or VACOped boot (lower leg boot with ankle immobilzation) for 6 weeks.
Functional treatment: Weightbearing as tolerated using a rigid-sole shoe.
Current treatment approaches range from operative management to conservative treatment with 6-8 weeks of immobilization, and more recently to functional treatment protocols. Most of the available evidence consists of case series, representing a low level of evidence. High-quality comparative studies are currently lacking.
As a public hospital, Hospital Cantonal Fribourg (HFR) manages a large number of regional trauma cases, including Chopart injuries, with an incidence of approximately 50 cases per year. At present, treatment at HFR is predominantly conservative, involving 8 weeks of immobilization in a cast or a VACOped boot. While immobilization allows sufficient time for fracture healing, it may result in muscle atrophy and ankle joint stiffness. Recent literature suggests that a more functional treatment approach may lead to promising results. However, it remains unclear whether earlier weightbearing and functional rehabilitation improve overall outcomes or result in prolonged pain and increases the risk of complications. Therefore, the aim of this study is to compare different non-operative treatment strategies using both patient-reported outcome measures and objective gait analysis.
The primary objective of this study is to evaluate patient-reported outcomes following different non-operative treatment strategies for Chopart fractures. In addition, the study will assess differences in gait patterns between the two study arms and correlate these findings with patient-reported outcomes and quality of life. The study also aims to determine the timeline required to regain a normal gait pattern after injury.
Outcome Measures The primary outcome will be patient-reported functional outcome and quality of life, assessed using a 22-item questionnaire combining the EFAS Score (European Foot and Ankle Society) and the Short Form-12 health survey. The secondary outcome will be objective gait analysis parameters.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Restrictive treatment: | Active Comparator | Immobilization in a cast or VACOped boot for 6 weeks |
|
| Functional treatment | Other | Weightbearing as tolerated using a rigid-sole shoe. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 6 weeks cast immobilization | Other | 6 weeks cast immobilization |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Patient reported outcome | European foot and ankle society score; minimum score of 0 points (worst possible) and a maximum score of 24 points (best possible). | 6 weeks, 3 months, 6 months, 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life | SF-12: The Short Form-12 health survey produces two main summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-which are normed to a mean of 50 and a standard deviation of 10 in the general U.S. population. Scores typically range from 0 to 100, where higher values indicate better | 6 weeks, 3 months, 6 months, 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Gait analysis | Will be performed by the Nushu: NUSHU smart shoes by Magnes AG provide medical-grade, real-time, in-shoe gait analysis and sensory feedback. Using AI-powered sensors, the system tracks over 35 gait parameters (e.g., speed, stride length, cadence, symmetry) to monitor disease progression. We already used the analysis for malleolar fractures | 6 weeks, 3 months, 6 months, 1 year |
Inclusion Criteria:
Exclusion Criteria:
Patient which does not understand the informed consent (due to language capacity or mental capacity)
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| Rigide sole |
| Other |
6 weeks of weight bearing as tolerated |
|