Hardware Removal After ORIF of Ankle Fractures

NCT05798741 | Not Yet Recruiting

• 1 other identifier: 2023-00026
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Ankle Fractures

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (2)

• pain-related disability after an ankle hardware removal

  6 months

• complication rate after an ankle hardware removal surgery

  6 months

Study Arms (2)

Hardware removal

EXPERIMENTAL

hardware removal

Procedure: Hardware removal

hardware retaining

NO INTERVENTION

Patients that retain their hardware

Interventions

Hardware removal PROCEDURE

The surgery of hardware removal after an ORIF of an ankle fracture

Hardware removal

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Hôpital Fribourgeois: lead

MeSH Terms

Conditions

Ankle Fractures

Interventions

Hardware Removal

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Ankle Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Device Removal; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2023
• First Posted: April 5, 2023
• Study Start: May 1, 2023
• Primary Completion: June 1, 2025
• Study Completion: March 1, 2026
• Last Updated: April 6, 2023

Record last verified: 2023-04