Hardware removal after ankle fracture surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective multicenter, randomized trial compares two approaches after ankle fracture repair: hardware removal versus no removal. Participants are adults with prior ORIF of the ankle and a 12-month follow-up window, randomized to either undergo hardware removal or continue without removal, with follow-up assessments at 12 and 18 months. Outcomes include the Foot and Ankle Ability Measure (FAAM) and Pain Disability Index (PDI), plus complication rates classified by Ernst-Sinck criteria. The study aims to clarify whether hardware removal provides meaningful functional or pain-related benefits after ankle fracture repair.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* \>18 y.o
* Operative treatment of ankle/foot fractures at HFR or RHNe:
* Ankle fractures: bi-malleolar and tri-malleolar fractures or equivalent
* FAAM score \>5%, \<95%
* Patient expected to complete length of study
* Patient with sufficient cognitive and linguistic ability in order to participate in the study.
* Operable patients (ASA score ≤3)

Exclusion Criteria:

* Absolute indications for HR: infection/malunion/allergy to metal/refracture
* Ankle fractures that are not listed in the criteria above
* Patient treated for a fracture at the same foot/ ankle before
* Patient with fracture of two different regions of the foot/ankle
* Patient treated for the fracture outside of HFR and RHNe
* Patient non ambulating before time of injury
* Patients having diabete,
* immunocompromised under chemotherapy,
* Peripheral artery disease stade IV
* Pregnant patients

Where it's running

• Hfr
  Fribourg, Switzerland Recruiting

Study contacts

• Study coordinator: Amal Chidda
• Email: amal.chidda@h-fr.ch
• Phone: +41788540681

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.