Ankle FracturesNCT05798741
Hardware Removal After ORIF of Ankle Fractures
A study testing Hardware removal in people with Ankle Fractures, run by Hôpital Fribourgeois at 1 site in Switzerland.
Trial summary
Ankle fractures account for 10 % of fractures in the adult population. A part of patients (40%) is treated surgically. After healing of the fractures, about one year after the operation, a surgery is often performed to remove the hardware in order to diminish pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ankle Fractures
- What is being tested?
- Hardware removal
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Oct 2023to 31 Dec 2028
- 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
- >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)
Who cannot join
- 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
Show all 10Show fewer
- Patients having diabete,
- immunocompromised under chemotherapy,
- Peripheral artery disease stade IV
- Pregnant patients
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
HFR
Fribourg, 1752
Amal Chidda, +41788540681, amal.chidda@h-fr.ch
About this study
Official title: Hardware Removal After ORIF of Ankle Fractures: A Randomized Trial
Ankle fractures account for 10 % of fractures in the adult population. A part of patients (40%) is treated surgically. After healing of the fractures, about one year after the operation, a surgery is often performed to remove the hardware in order to diminish pain. If this surgery is necessary is debated in the literature.
The aim of our study is to evaluate the outcome of hardware removal surgery after a surgery of the ankle for a fracture. For that, we will perform do a controlled randomized trial with two arms: one arm includes the participants who will have a hardware removal and the other arm will not have a surgery.
Outcome parameters are the patients reported outcome and pain related disability. They will be assessed by the questionnaires FAAM score (Foot and Ankle Ability Measure) and PDI (Pain Disability Index) at the beginning and at the end of the study, at six months. The third outcome parameter will be the complication rate after an anklehardware removal surgery, which will be assessed through the Ernst-Ssink classification.
Read the detailed description
The study consists of a prospective multicentric parallel two-arm randomised non-blinded study, conducted at the HFR and RHNe (level of evidence II).
The planned intervention is the following: after an ORIF of the ankle, patients have a follow-up. At the 12- month control, we ask eligible patients if they want to participate to the study. If they agree, they are randomised to treatment recommendations in one of two groups: conservative or surgical. The patients may follow or not the recommendations; not following the recommendations does not exclude them from the study. Patients of both groups will fill out FAAM and PDI questionnaires at 12 and 18 months after the 1st operation. Patients in the surgical group will have a hardware removal surgery. It is a very common operation consisting of hardware removal that is done ambulatory by the orthopaedic surgeons specialized in foot and ankle surgery. Operated patients will have the usual postoperative follow-up (6 weeks, 3 months and 6 months postoperative) and all complications will be recorded and classified according to the Ernst-sink classification
- Conditions
- Ankle Fractures
- Being tested
- Hardware removal
- Medical subject headings
- Ankle Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hardware removalProcedure or surgery
The surgery of hardware removal after an ORIF of an ankle fracture
| Study group | Role | What they receive |
|---|---|---|
| Hardware removal | Experimental | hardware removal Receives: Procedure: Hardware removal |
| hardware retaining | No intervention | Patients that retain their hardware |
What is being measured
The primary outcome is the main question the study is designed to answer.
patient reported outcome after an ankle hardware removal
FAAM score (Foot and Ankle Ability Measure). FAAM subdivided in AVQ scale(84 points) and Sport scale (32 points). The higher is a better outcome.
Measured: 6 months
Secondary outcomes (2)
pain-related disability after an ankle hardware removal
PDI (Pain Disability Index). Total of 70 points. The higher means a worse outcome.
Measured: 6 months
complication rate after an ankle hardware removal surgery
Ernst-sink classification
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2023
- Study start1 Oct 2023
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
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
- 100 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
- NCT05798741
- Sponsor's protocol ID
- 2023-00026
- Other IDs
- 2023
- Status last verified
- Oct 2026
- First submitted
- 22 Mar 2023
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hardware Removal After ORIF of Ankle Fractures: A Randomized Trial
- ClinicalTrials.gov ID
- NCT05798741
- Acronym / sponsor ID
- 2023-00026
- Conditions
- Ankle Fractures
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hôpital FribourgeoisUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 5 Apr 2023 (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.
Ankle fractures account for 10 % of fractures in the adult population. A part of patients (40%) is treated surgically. After healing of the fractures, about one year after the operation, a surgery is often performed to remove the hardware in order to diminish pain. If this surgery is necessary is debated in the literature.
The aim of our study is to evaluate the outcome of hardware removal surgery after a surgery of the ankle for a fracture. For that, we will perform do a controlled randomized trial with two arms: one arm includes the participants who will have a hardware removal and the other arm will not have a surgery.
Outcome parameters are the patients reported outcome and pain related disability. They will be assessed by the questionnaires FAAM score (Foot and Ankle Ability Measure) and PDI (Pain Disability Index) at the beginning and at the end of the study, at six months. The third outcome parameter will be the complication rate after an anklehardware removal surgery, which will be assessed through the Ernst-Ssink classification.
Detailed description
The study consists of a prospective multicentric parallel two-arm randomised non-blinded study, conducted at the HFR and RHNe (level of evidence II).
The planned intervention is the following: after an ORIF of the ankle, patients have a follow-up. At the 12- month control, we ask eligible patients if they want to participate to the study. If they agree, they are randomised to treatment recommendations in one of two groups: conservative or surgical. The patients may follow or not the recommendations; not following the recommendations does not exclude them from the study. Patients of both groups will fill out FAAM and PDI questionnaires at 12 and 18 months after the 1st operation. Patients in the surgical group will have a hardware removal surgery. It is a very common operation consisting of hardware removal that is done ambulatory by the orthopaedic surgeons specialized in foot and ankle surgery. Operated patients will have the usual postoperative follow-up (6 weeks, 3 months and 6 months postoperative) and all complications will be recorded and classified according to the Ernst-sink classification
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hardware removal | Experimental | Procedure: Hardware removalhardware removal |
| hardware retaining | No intervention | –Patients that retain their hardware |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- >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
Key exclusion criteria (10 listed)
- 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
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 |
|---|---|---|
| Hardware removalThe surgery of hardware removal after an ORIF of an ankle fracture | Procedure or surgery | Hardware removal |
Primary outcome
patient reported outcome after an ankle hardware removal
Time frame: 6 months
FAAM score (Foot and Ankle Ability Measure). FAAM subdivided in AVQ scale(84 points) and Sport scale (32 points). The higher is a better outcome.
2 secondary outcomes
pain-related disability after an ankle hardware removal
Time frame: 6 months
complication rate after an ankle hardware removal surgery
Time frame: 6 months
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 23 Oct 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hardware removal in people with Ankle Fractures, run by Hôpital Fribourgeois at 1 site in Switzerland.
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 7 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: looking for participants now, as of the sponsor's last update on 23 Oct 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 Switzerland. 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?
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?
Contact Amal Chidda (+41788540681, amal.chidda@h-fr.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
patient reported outcome after an ankle hardware removal (time frame: 6 months). 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 23 Oct 2026.