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

Chopart Injury, Randomized Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Foot Ankle Injuries
• Intervention / Treatment: Other: 6 weeks cast immobilization; Other: Rigide sole

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Restrictive treatment: Immobilization in a cast or VACOped boot for 6 weeks	Other: 6 weeks cast immobilization; 6 weeks cast immobilization
Other: Functional treatment; Weightbearing as tolerated using a rigid-sole shoe.	Other: Rigide sole; 6 weeks of weight bearing as tolerated

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Hôpital Fribourgeois

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2030

Study Registration Dates

• First Submitted: March 2, 2026
• First Submitted That Met QC Criteria: March 13, 2026
• First Posted (Actual): March 17, 2026

Study Record Updates

• Last Update Posted (Actual): March 17, 2026
• Last Update Submitted That Met QC Criteria: March 13, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: Chopart trial

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No