Functional Outcome Assessment After (Calcaneal) Trauma Surgey
FACTS
1 other identifier
observational
20
0 countries
N/A
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Oct 2011
Typical duration for all trials
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
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 5, 2015
CompletedFirst Posted
Study publicly available on registry
October 15, 2015
CompletedOctober 15, 2015
December 1, 2010
3.4 years
October 5, 2015
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
healthy subjects
patients without foot and ankle fracture s
Interventions
Eligibility Criteria
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
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