Ankle FracturesNCT07814638
Immediate Protected Weight Bearing Versus Conventional Non-Weight Bearing After Surgical Fixation of Unstable Ankle Fractures
A study testing Immediate protected weight bearing and Rehabilitation in people with Ankle Fractures and Unstabel Ankle Fractures, run by Consorci Sanitari Integral at 1 site in Spain.
Trial summary
This prospective randomized controlled trial evaluates the safety and effectiveness of immediate protected weight bearing following surgical fixation of unstable ankle fractures. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ankle Fractures, Unstabel Ankle Fractures
- What is being tested?
- Immediate protected weight bearing and Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteSpain
- Study dates
- 15 Jan 2023to 15 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unstable ankle fracture requiring ORIF.
- Written informed consent.
Who cannot join
- Psychiatric disorder.
- Pre-existing mobility limitation.
- Cognitive impairment.
- BMI >30 kg/m².
- Poorly controlled type 2 diabetes.
- Soft tissue injury requiring external fixation.
Show all 10Show fewer
- Gustilo II/III open fractures.
- Unstable fixation.
- Refusal/inability to consent or allow anonymized data use.
- Any condition compromising safety or validity.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Sant Joan Despí Moisès Broggi - Consorci Sanitari Integral
Sant Joan Despí, Barcelona, 08970
About this study
Official title: Immediate Protected Weight Bearing Versus Conventional Non-Weight Bearing After Surgical Fixation of Unstable Ankle Fractures: A Prospective Randomized Controlled Trial
This prospective randomized controlled trial evaluates the safety and effectiveness of immediate protected weight bearing following surgical fixation of unstable ankle fractures. Participants are randomized to immediate protected weight bearing from the first postoperative day using a Walker boot and crutches or conventional non-weight bearing for six weeks. Functional outcome (OMAS), pain (VAS), ankle range of motion, quality of life (SF-12), and postoperative complications are assessed over 12 months.
- Conditions
- Ankle Fractures, Unstabel Ankle Fractures
- Being tested
- Immediate protected weight bearing, Rehabilitation
- Keywords
- Ankle fracture, Immediate protected weight bearing, Rehabilitation, Walker boot, Randomized controlled trial
- Medical subject headings
- Ankle Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate protected weight bearingOther
Immediate protected weight bearing from postoperative day 1 using a Walker boot and crutches
RehabilitationOther
Standardised rehabilitation after surgery
| Study group | Role | What they receive |
|---|---|---|
| Immediate protected weight bearing | Experimental | Immediate protected weight bearing from postoperative day 1 using a Walker boot and crutches plus standardized rehabilitation Receives: Other: Immediate protected weight bearing; Other: Rehabilitation |
| Conventional treatment | Active comparator | Conventional non-weight bearing for 6 weeks followed by progressive weight bearing plus standardized rehabilitation Receives: Other: Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Olerud-Molander Ankle Score (OMAS).
Measured: 6 weeks, 12 weeks, 6 months and 12 months after surgery
Secondary outcomes (2)
Visual Analogic Scale (VAS) for pain
Measured: 6 weeks, 12 weeks, 6 months and 12 months.
SF-12 quality of life
Measured: 6 weeks, 12 weeks, 6 months and 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2026
- Study start15 Jan 2023
- Primary completion15 Jan 2025
- Study completion15 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle FracturesStudies 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
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Consorci Sanitari Integral
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07814638
- Sponsor's protocol ID
- 22/52
- Status last verified
- Sep 2026
- First submitted
- 7 Sep 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Protected Weight Bearing Versus Conventional Non-Weight Bearing After Surgical Fixation of Unstable Ankle Fractures: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07814638
- Acronym / sponsor ID
- 22/52
- Conditions
- Ankle Fractures, Unstabel Ankle Fractures
- Keywords
- Ankle fracture, Immediate protected weight bearing, Rehabilitation, Walker boot, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Consorci Sanitari IntegralUniversity, hospital or other
- Study start
- 15 Jan 2023 (actual)
- Primary completion
- 15 Jan 2025 (actual)
- Study completion
- 15 Jan 2026 (actual)
- First posted
- 11 Sep 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.
This prospective randomized controlled trial evaluates the safety and effectiveness of immediate protected weight bearing following surgical fixation of unstable ankle fractures. Participants are randomized to immediate protected weight bearing from the first postoperative day using a Walker boot and crutches or conventional non-weight bearing for six weeks. Functional outcome (OMAS), pain (VAS), ankle range of motion, quality of life (SF-12), and postoperative complications are assessed over 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate protected weight bearing | Experimental | Other: Immediate protected weight bearing, Other: RehabilitationImmediate protected weight bearing from postoperative day 1 using a Walker boot and crutches plus standardized rehabilitation |
| Conventional treatment | Active comparator | Other: RehabilitationConventional non-weight bearing for 6 weeks followed by progressive weight bearing plus standardized rehabilitation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Unstable ankle fracture requiring ORIF.
- Written informed consent.
Key exclusion criteria (10 listed)
- Psychiatric disorder.
- Pre-existing mobility limitation.
- Cognitive impairment.
- BMI >30 kg/m².
- Poorly controlled type 2 diabetes.
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 |
|---|---|---|
| Immediate protected weight bearingImmediate protected weight bearing from postoperative day 1 using a Walker boot and crutches | Other | Immediate protected weight bearing |
| RehabilitationStandardised rehabilitation after surgery | Other | Conventional treatment, Immediate protected weight bearing |
Primary outcome
Olerud-Molander Ankle Score (OMAS).
Time frame: 6 weeks, 12 weeks, 6 months and 12 months after surgery
2 secondary outcomes
Visual Analogic Scale (VAS) for pain
Time frame: 6 weeks, 12 weeks, 6 months and 12 months.
SF-12 quality of life
Time frame: 6 weeks, 12 weeks, 6 months and 12 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate protected weight bearing and Rehabilitation in people with Ankle Fractures and Unstabel Ankle Fractures, run by Consorci Sanitari Integral at 1 site in Spain.
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 2 inclusion and 10 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: finished, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Olerud-Molander Ankle Score (OMAS). (time frame: 6 weeks, 12 weeks, 6 months and 12 months after surgery). 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 11 Sep 2026.