Foot Ankle InjuriesNCT07477327
Is 6 Weeks Immobilization for a Chopart Injury Still State of the Art? Comparison Between Cast Immobilization Versus Functional Treatment
A study testing 6 weeks cast immobilization and Rigide sole in people with Foot Ankle Injuries, run by Hôpital Fribourgeois.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Foot Ankle Injuries
- What is being tested?
- 6 weeks cast immobilization and Rigide sole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 1 Oct 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Chopart Injury, Randomized Trial
Treatment Arms for Randomization
- Restrictive treatment: Immobilization in a cast or VACOped boot (lower leg boot with ankle immobilzation) for 6 weeks.
Read more
- Advantage: Provides stable conditions for fracture healing.
- Disadvantage: Risk of muscle atrophy and ankle joint stiffness due to prolonged immobilization.
- 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.
- Conditions
- Foot Ankle Injuries
- Being tested
- 6 weeks cast immobilization, Rigide sole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6 weeks cast immobilizationOther
6 weeks cast immobilization
Rigide soleOther
6 weeks of weight bearing as tolerated
| Study group | Role | What they receive |
|---|---|---|
| Restrictive treatment: | Active comparator | Immobilization in a cast or VACOped boot for 6 weeks Receives: Other: 6 weeks cast immobilization |
| Functional treatment | Other | Weightbearing as tolerated using a rigid-sole shoe. Receives: Other: Rigide sole |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 weeks, 3 months, 6 months, 1 year
Secondary outcomes (1)
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
Measured: 6 weeks, 3 months, 6 months, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Oct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Foot Ankle InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hôpital Fribourgeois
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07477327
- Sponsor's protocol ID
- Chopart trial
- Status last verified
- Mar 2026
- First submitted
- 2 Mar 2026
- Last updated
- 17 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chopart Injury, Randomized Trial
- ClinicalTrials.gov ID
- NCT07477327
- Acronym / sponsor ID
- Chopart trial
- Conditions
- Foot Ankle Injuries
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Hôpital FribourgeoisUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Oct 2030 (estimated)
- First posted
- 17 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Treatment Arms for Randomization
- 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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Restrictive treatment: | Active comparator | Other: 6 weeks cast immobilizationImmobilization in a cast or VACOped boot for 6 weeks |
| Functional treatment | Other | Other: Rigide soleWeightbearing as tolerated using a rigid-sole shoe. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Patient which does not understand the informed consent (due to language capacity or mental capacity)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 6 weeks cast immobilization6 weeks cast immobilization | Other | Restrictive treatment: |
| Rigide sole6 weeks of weight bearing as tolerated | Other | Functional treatment |
Primary outcome
Patient reported outcome
Time frame: 6 weeks, 3 months, 6 months, 1 year
European foot and ankle society score; minimum score of 0 points (worst possible) and a maximum score of 24 points (best possible).
1 secondary outcome
Quality of life
Time frame: 6 weeks, 3 months, 6 months, 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
Related trials for Foot Ankle Injuries
Recruiting
Investigating Auto Adjusting Dynamic AFO
Lower Limb; Fusion, Congenital, Lower Limb Fracture
Not yet recruiting
Outpatient Floor Pedal Bike Utilization
Femur Fracture, Tibia Fracture
RecruitingObservational study
Systemic Biochemical Signature and Functional Quality Index of Calcaneal Bone Marrow Aspirate in Adults Undergoing Foot or Ankle Surgery
Diabetic Foot Ulcer, Wound Healing
Recruiting
From Opinion to Evidence: Multi-site Evaluation of Custom Dynamic Orthosis Best Practices
Foot Injury
Recruiting
The Effects of AFO Heel Height and Stiffness on Gait
Musculoskeletal Injury, Musculoskeletal Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing 6 weeks cast immobilization and Rigide sole in people with Foot Ankle Injuries, run by Hôpital Fribourgeois.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient reported outcome (time frame: 6 weeks, 3 months, 6 months, 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.