NCT02576730

Brief Summary

To include patient after traumatic (calcaneal) fractures for this study. They can be included to analyze gait with the OFM foot model, a non invasis model. Patient will be invited to the movement laboratory of the MUMC. Markers will be detached with dubble sided tape on anatomical points. After that gait will be recorded with infra-red camera's and an animation model will be formed. With this model further analysis can be made to range of motion between different segement of the foot. These results will be compared with patient with an arthrodesis, healthy subjects, futher questionnaires, physical examination and radiographic findings will be correlated.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2011

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 5, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 15, 2015

Completed
Last Updated

October 15, 2015

Status Verified

December 1, 2010

Enrollment Period

3.4 years

First QC Date

October 5, 2015

Last Update Submit

October 13, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • Gait in Patients After foot and ankle fractures range of motion

    To measure range of motion in the foot and ankle with the OFM (range of motion in degrees) and compare between patients with foot and ankle fractures after surgery and healthy subjects range of motion between forefoot and hindfoot, hindfoot and tibia in 3 planes representing flexion/extension, abduction/adduction, inversion/eversion

    6 months after surgery

Secondary Outcomes (1)

  • To find correlations between gait, questionnaires, radiographic findings and physical examination

    6 months after surgery

Study Arms (2)

Fratures

patient with foot and ankle fractures and surgery with ORIF

Procedure: ORIF

healthy subjects

patients without foot and ankle fracture s

Interventions

ORIFPROCEDURE

surgery for foot and ankle fractures

Fratures

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

healthy subjects and patients after foot and ankle trauma fracture surgery

You may qualify if:

  • patients with foot and ankle fractures

You may not qualify if:

  • concomitant surgery for fractures of contra lateral leg/ankle or pre-existent abnormalities of the lower extremities, neurotrauma, spinal or neurological injury, pathologic fractures and people dependent in activities of daily living

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Fractures, BoneWounds and Injuries

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2015

First Posted

October 15, 2015

Study Start

October 1, 2011

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

October 15, 2015

Record last verified: 2010-12