Prognostic Factors Following Ankle Fractures

Ankle Fractures Clinical Trial

Official title:

Recovery Following Ankle Fracture Reported by Patient Report Outcome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03741556
• Other study ID #: Ver2
• Status: Completed
• Start date: November 7, 2018
• Est. completion date: October 1, 2022

Study information

• Verified date: August 2023
• Source: Sygehus Lillebaelt
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

Aim of study:

To identify prognostic factors associated with a worse outcome following ankle fractures.

Method:

All operated or non-operated ankle fractures in a period of one year from three different hospitals will be included. The following data will be recorded:

Civil registration number, age, rupture of the syndesmosis, use of alcohol, smoking, diabetes, characteristics of the ankle fracture (AO classification), type of treatment and complications.

Study participants will at time of diagnosis and 6, 12, 52 and 104 weeks following the injury received a questionaire with Manchester foot and ankle questionnaire (MOXFQ), Self-reported foot and ankle questionnaire (SEFAS), Olerud Molander Ankle Score (OMAS) and Forgotten Joint Score (FJS).

Which of the questionaire that should be used in the study will be determined when the questionaires have been compared in a different study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: October 1, 2022
• Est. primary completion date: July 1, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All patients with ankle fracture.

Exclusion Criteria:

• age below 18 years

• patients who do not speak or understand danish

• mental disable patients

Related Conditions & MeSH terms

• Ankle Fractures
• Fractures, Bone

Intervention

Other:
• questionaire
a questionaire is sent to each participans

Locations

Country	Name	City	State
Denmark	Amager Hvidovre Hospital	Copenhagen
Denmark	Sygehus Lillebaelt	Kolding
Denmark	Odense University Hospital	Odense

Sponsors (2)

Lead Sponsor	Collaborator
Sygehus Lillebaelt	Kolding Sygehus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	EQ5D-3L	The EQ5D-3L is a generic PROM and does not specifically address foot and ankle disability. The EQ-5D-3L includes five items with a three-point response scale which are scored to give a single index, with 0 representing the worse possible disability. It also includes a visual analoug scale (VAS) to assess general health, ranging from 0-100, with 0 representing the worse possible health state	2 years