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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02576730
Other study ID # NL34131.068.10/ MEC 10-3-072
Secondary ID
Status Completed
Phase N/A
First received October 5, 2015
Last updated October 13, 2015
Start date October 2011
Est. completion date March 2015

Study information

Verified date December 2010
Source Maastricht University Medical Center
Contact n/a
Is FDA regulated No
Health authority Netherlands: Medical Ethics Review Committee (METC)
Study type Observational

Clinical Trial 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.


Description:

All subjects are asked to come to the movement laboratory of Maastricht University Medical Centre on one individual day. Before gait analyses the following characteristics were measured; height, weight, BMI, knee and ankle width (measured between the two condyles of the knee and the measured between the two malleoli of the ankle) and leg length . All measurements are performed by researchers who was trained in the examination of the foot. At least one static trial was performed with all 42 markers, with the subjects in stance phase in an anatomic neutral position. After calibrating the markers and calculating the subject-specific joint axes in the static trial, 6 markers were removed, according to the OFM protocol. After that the subjects were asked to walk barefoot in normal speed after a number of practice trials. For this speed at least 8 proper recordings were made during walking. The healthy subjects were also asked to walk in slow speed and 8 proper recordings were made during this slow-speed walking. One whole step was considered complete from heel landing (initial contact) to toe-off. A force plate was used to determine the heel-strike and toe-off phase during walking. Corrections in the axes of the knee and ankle were made if necessary and tiles were saved for further data output.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date March 2015
Est. primary completion date March 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria:

- patients with foot and ankle fractures

Exclusion Criteria:

- 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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective


Related Conditions & MeSH terms


Intervention

Procedure:
ORIF
surgery for foot and ankle fractures

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Maastricht University Medical Center

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Yes
Secondary To find correlations between gait, questionnaires, radiographic findings and physical examination correlations between gait (OFM, see above) AOFAS score (0-100_ Foot and ankle disability index FADI 0-100 VAS pain score (0-10) Short Form 36 SF 36 physical examination range of motion in the subtalar joint (inversion/eversion) in degrees en in the ankle (flexion/extension) degrees radiographic findings (in calcaneal patients, bohlers angle, gissane's angle) in general congruency of the joint with step-off and gap 6 months after surgery Yes
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