An interventional study of Immediate protected weight bearing and Rehabilitation in Ankle Fractures and Unstabel Ankle Fractures, sponsored by Consorci Sanitari Integral. Completed at 1 site in Spain. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-11.
Sponsored by Consorci Sanitari Integral · Not applicable, Interventional, and Treatment
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.
202 studies on the registry are indexed under Ankle Fractures; 44 are open to participants now.
This study's enrollment of 102 is above the median of 90 across 150 interventional studies indexed under Ankle Fractures.
Browse Ankle Fractures studies →Consorci Sanitari Integral is the lead sponsor of 16 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immediate protected weight bearing from postoperative day 1 using a Walker boot and crutches plus standardized rehabilitation
Other: Immediate protected weight bearing · Other: Rehabilitation
Conventional non-weight bearing for 6 weeks followed by progressive weight bearing plus standardized rehabilitation
Other: Rehabilitation
Immediate protected weight bearing from postoperative day 1 using a Walker boot and crutches
Standardised rehabilitation after surgery
Olerud-Molander Ankle Score (OMAS).
Time frame: 6 weeks, 12 weeks, 6 months and 12 months after surgery
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.
Plan to share: No
No publications or documents are linked to this record.
Ran from Jan 2023 to primary completion in Jan 2025, 24 months.
Of 69 non-industry interventional studies with no phase under Ankle Fractures, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 61. This study's 24 months is below that.
Counting every sponsor, half of 72 studies reached it within 45 months; a quarter within 23 and three quarters within 61.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Consorci Sanitari Integral