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Register:	German Clinical Trials Register
Last refreshed on:	8 April 2024
Main ID:	DRKS00013080
Date of registration:	01/12/2017
Prospective Registration:	No
Primary sponsor:	Klinik für UnfallchirurgieUniversitätsklinikum des Saarlandes
Public title:	Long-term pathological gait pattern changes after talus fractures – dynamic measurements with a new insole
Scientific title:	Long-term pathological gait pattern changes after talus fractures – dynamic measurements with a new insole - Gait Talus
Date of first enrolment:	23/10/2015
Target sample size:	55
Recruitment status:	Complete
URL:	http://drks.de/search/en/trial/DRKS00013080
Study type:	observational
Study design:	Allocation: ; Masking: ; Control: ; Assignment: ; Study design purpose: diagnostic
Phase:

Countries of recruitment
Germany

Contacts

Name:	Benedikt Braun
Address:	Kirrbergerstr. 1 66421 Homburg Germany
Telephone:	06841 16 31076
Email:	benedikt.braun@uks.eu
Affiliation:	Klinik für UnfallchirurgieUniversitätsklinikum des Saarlandes

Name:	Benedikt Braun
Address:	Kirrbergerstr. 1 66421 Homburg Germany
Telephone:	06841 16 31076
Email:	benedikt.braun@uks.eu
Affiliation:	Klinik für UnfallchirurgieUniversitätsklinikum des Saarlandes

Key inclusion & exclusion criteria

Inclusion criteria: All operatively treated, unilateral talar body and neck fractures treated between 2002 and 2014
Exclusion criteria: Impaired mobility, or gait abnormalities before the fracture event, fracture non-union, patients below the age of 18 years and patients with shoe sizes outside the range of 36-45 (EU)

Age minimum: 18 Years
Age maximum: None
Gender: All

Health Condition(s) or Problem(s) studied

S92.1

Fracture of talus

Intervention(s)

Group 1: Single Arm Study; Observational; One Time Follow Up Retrospective with a Gait Analysis Insole; Clinical Outcome at follow-up (AOFAS Score; Olerud Mokanter Score), as well as Gait Changes at follow-up (Kinetic (Step-force-integral, Maximum-load), temporospatial (stance-time, swing-time, double-support-time, gait-cycle-time, cadence) and average anteroposterior (ap) and mediolateral (ml) center-of-pressure (COP) excursion) and the most recent radiographic imaging at follow-up (Bargon Score) were reviewed.

Mean follow-up was at 78.3 months (range 21 – 150 months).

Primary Outcome(s)

Clinical Outcome at follow-up (AOFAS Score; Olerud Mokanter Score)

Mean follow-up 78.3 months (range 21 – 150 months)

Secondary Outcome(s)

Gait Changes at follow-up (Kinetic (Step-force-integral, Maximum-load), temporospatial (stance-time, swing-time, double-support-time, gait-cycle-time, cadence) and average anteroposterior (ap) and mediolateral (ml) center-of-pressure (COP) excursion)
Most recent radiographic imaging at follow-up (Bargon Score)

Mean follow-up 78.3 months (range 21 – 150 months)

Secondary ID(s)

Source(s) of Monetary Support

AO Trauma

Secondary Sponsor(s)

Ethics review

Status: Approved
Approval date: 19/01/2015
Contact:

Results

Results available:
Date Posted:
Date Completed:	22/01/2016
URL:	http://drks.de/search/en/trial/DRKS00013080#studyResults

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