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Is 6 Weeks Immobilization for a Chopart Injury Still State of the Art? Comparison Between Cast Immobilization Versus Functional Treatment

Chopart Injury, Randomized Trial

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07477327
Enrollment
70
Registered
2026-03-17
Start date
2026-10-01
Completion date
2030-10-01
Last updated
2026-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Foot Ankle Injuries

Brief summary

Treatment Arms for Randomization 1. Restrictive treatment: Immobilization in a cast or VACOped boot (lower leg boot with ankle immobilzation) for 6 weeks. * Advantage: Provides stable conditions for fracture healing. * Disadvantage: Risk of muscle atrophy and ankle joint stiffness due to prolonged immobilization. 2. Functional treatment: Weightbearing as tolerated using a rigid-sole shoe. * Advantage: Allows early mobilization, reduces muscle atrophy, and helps maintain ankle mobility. * Disadvantage: Potential concern regarding pain, insufficient fracture stabilization, or pseudarthrosis Study Objectives This research project focuses on the treatment of Chopart fractures. In recent years, the number of diagnosed fractures following ankle sprains has increased. This rise is likely due to improved awareness of these injuries and the more frequent use of advanced imaging techniques such as CT scans (Computed Tomography). However, the optimal treatment strategy for these fractures remains unclear. 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.

Interventions

OTHER6 weeks cast immobilization

6 weeks cast immobilization

OTHERRigide sole

6 weeks of weight bearing as tolerated

Sponsors

Hôpital Fribourgeois
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients aged above 18 years * Patient with a pure ligament Chopart injury or bony avulsion of the ligaments of the Chopart joint line * Patient expected to complete length of study

Exclusion criteria

* Patient which does not understand the informed consent (due to language capacity or mental capacity) * Patient non ambulating before time of injury * Patient treated for the fracture outside of Hopital Cantonal Fribourg (the study side) * Patient treated for a fracture at the same foot/ ankle before

Design outcomes

Primary

MeasureTime frameDescription
Patient reported outcome6 weeks, 3 months, 6 months, 1 yearEuropean foot and ankle society score; minimum score of 0 points (worst possible) and a maximum score of 24 points (best possible).

Secondary

MeasureTime frameDescription
Quality of life6 weeks, 3 months, 6 months, 1 yearSF-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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 18, 2026