NCT04429217 A Study to Compare Two Different Managements After Ankle Surgery: Immediate and Delayed Weight-bearing.
| NCT ID | NCT04429217 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ente Ospedaliero Cantonale, Bellinzona |
| Condition | Lateral Malleolus Fracture |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2020-04-28 |
| Primary Completion | 2028-02-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2020-04-28 with a primary completion date of 2028-02-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The investigators will compare two types of rehabilitation in patients who undergo a surgery for treatment of malleolar fractures: immediate complete weight-bearing and delayed weight-bearing. The investigators want to evaluate if the immediate complete weight-bearing can improve and hasten the functional outcome of the ankle without increasing the risk of complications.
Eligibility Criteria
Inclusion Criteria: * Male and female adults * Age ranging from 18 to 70 years, included * Signed Informed Consent * Ankle fracture requiring surgical management classified as:1- Weber A fracture pattern (AO 44.A1, 44.A2, 44.A3) with or without association with a medial or posterior lesion/fracture or 2- Weber B fracture pattern (AO 44.B1, 44.B2, 44.B3) with or without association with a medial or posterior lesion/fracture * Willingness and ability to participate in the trial Exclusion Criteria: * Weber C fracture pattern * Bilateral fractures or fractures in other locations * Maissoneauve associated lesion * Body Mass Index \< 18.5 and ≥ 30 * Metabolic diseases influencing fracture healing processes * Medical comorbidities precluding operative intervention * Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, general physical problem of the participant, etc. * Inability or contraindications to undergo the investigated intervention * Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.) * Pregnant women
Contact & Investigator
Enrique Adrian Testa, MD
PRINCIPAL INVESTIGATOR
EOC
Frequently Asked Questions
Who can join the NCT04429217 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Lateral Malleolus Fracture. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04429217 currently recruiting?
Yes, NCT04429217 is actively recruiting participants. Contact the research team at enriqueadrian.testa@eoc.ch for enrollment information.
Where is the NCT04429217 trial being conducted?
This trial is being conducted at Lugano, Switzerland.
Who is sponsoring the NCT04429217 clinical trial?
NCT04429217 is sponsored by Ente Ospedaliero Cantonale, Bellinzona. The principal investigator is Enrique Adrian Testa, MD at EOC. The trial plans to enroll 100 participants.