search
Back to results

Hardware Removal After ORIF of Ankle Fractures

Primary Purpose

Ankle Fractures

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Hardware removal
Sponsored by
Hôpital Fribourgeois
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankle Fractures

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Hardware removal

    hardware retaining

    Arm Description

    hardware removal

    Patients that retain their hardware

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    pain-related disability after an ankle hardware removal
    PDI (Pain Disability Index). Total of 70 points. The higher means a worse outcome.
    complication rate after an ankle hardware removal surgery
    Ernst-sink classification

    Full Information

    First Posted
    March 22, 2023
    Last Updated
    April 4, 2023
    Sponsor
    Hôpital Fribourgeois
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05798741
    Brief Title
    Hardware Removal After ORIF of Ankle Fractures
    Official Title
    Hardware Removal After ORIF of Ankle Fractures: A Randomized Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 1, 2023 (Anticipated)
    Primary Completion Date
    June 1, 2025 (Anticipated)
    Study Completion Date
    March 1, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Hôpital Fribourgeois

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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. 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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ankle Fractures

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Hardware removal
    Arm Type
    Experimental
    Arm Description
    hardware removal
    Arm Title
    hardware retaining
    Arm Type
    No Intervention
    Arm Description
    Patients that retain their hardware
    Intervention Type
    Procedure
    Intervention Name(s)
    Hardware removal
    Intervention Description
    The surgery of hardware removal after an ORIF of an ankle fracture
    Primary Outcome Measure Information:
    Title
    patient reported outcome after an ankle hardware removal
    Description
    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.
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    pain-related disability after an ankle hardware removal
    Description
    PDI (Pain Disability Index). Total of 70 points. The higher means a worse outcome.
    Time Frame
    6 months
    Title
    complication rate after an ankle hardware removal surgery
    Description
    Ernst-sink classification
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Learn more about this trial

    Hardware Removal After ORIF of Ankle Fractures

    We'll reach out to this number within 24 hrs