Prognostic Factors Following Ankle Fractures

NCT03741556 | Completed DMC

• 1 other identifier: Ver2
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 3

Brief Summary

Ankel fractures is a common fracture. Most patients experience that the regain normal range of motions and limited pain within the first 6 months following ankel fracture, but not all. The aim of the study is to determine if any prognostic factors is associated with a worse outcome.

Conditions

Ankle Fractures

Outcome Measures

Primary Outcomes (4)

• Manchester foot and ankle questionnaire (MOXFQ)

  Manchester foot and ankle questionnaire (MOXFQ) a Patient reported outcome measure. The MOXFQ contains 16 items, each with five response options, comprising three dimensions: walking/standing problems (seven items), foot pain (five items), and issues related to social interaction (four items), including feelings of self consciousness about foot/footwear appearance. Responses are each scored from 0 to 4, with 4 representing the most severe response. Item responses are summed to give a score from 0-100, with higher score representing the worse possible

  2 years

• Self-reported foot and ankle questionnaire (SEFAS)

  The Self-reported foot and ankle questionnaire (SEFAS) comprises twelve items relating to pain, limping, swelling, use of orthotics and walking. Response scales vary from 1 to 5, 1 being the most severe response. Item responses are summed to give a score from 12-60, with higher scores representing the best possible.

  2 years

• Olerud Molander Ankle Score (OMAS)

  The Olerud Molander Ankle Score (OMAS) comprises nine items relating to symptoms, physical function and daily activities. The response scales vary from binary to five-points with clinical scoring that reflects the level of disability for individual items. Item responses are summed to give a score from 0 to 100 with higher scores representing the best possible

  2 years

• Forgotten Joint Score (FJS)

  The forgotten Joint Score (FJS) is a 12-item questionnaire concerning the participiants awareness of their artificial joint during ADL. For each question, the participant can choose between 6 response options: never, almost never, seldom, sometimes, mostly, or not relevant for me. All responses are summed from 0-4 with a total score from 0-100 with higher scores representing the worse possible

  2 years

Secondary Outcomes (1)

• EQ5D-3L

  2 years

Interventions

questionaire OTHER

a questionaire is sent to each participans

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients with an ankle fracture, treated either with an operation or non-operative in one of three hospitals

You may qualify if:

• All patients with ankle fracture.

You may not qualify if:

• age below 18 years
• patients who do not speak or understand danish
• mental disable patients

Sponsors & Collaborators

• Sygehus Lillebaelt: lead
• Kolding Sygehus: collaborator

Study Sites (3)

Amager Hvidovre Hospital

Copenhagen, 2650, Denmark

Location

Sygehus Lillebaelt

Kolding, 6000, Denmark

Location

Odense University Hospital

Odense, 5000, Denmark

Location

MeSH Terms

Conditions

Ankle Fractures

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Senior House Officer, PhD

Study Record Dates

• First Submitted: November 6, 2018
• First Posted: November 15, 2018
• Study Start: November 7, 2018
• Primary Completion: July 1, 2020
• Study Completion: October 1, 2022
• Last Updated: August 7, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (3)