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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01804491
Other study ID # 252-2006-130228
Secondary ID
Status Completed
Phase N/A
First received March 1, 2013
Last updated March 1, 2013
Start date October 2006
Est. completion date August 2009

Study information

Verified date March 2013
Source University Hospital Heidelberg
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Observational

Clinical Trial Summary

The aim was to investigate with a multi-segmental foot model the kinetic and kinematic in patients with a hallux rigidus, before and after different type of surgery.


Description:

None of the patients received surgery BECAUSE of the study. We have only performed motion analysis in patients, who were already scheduled for one of the described type of surgery (prospective group) or who already previously received one the type of surgery (retrospective group).


Recruitment information / eligibility

Status Completed
Enrollment 56
Est. completion date August 2009
Est. primary completion date August 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- patients with osteoarthritis of one or both first metatarso-phalangeal joints (hallux rigidus)

- patients after surgery due to osteoarthritis of one or both first metatarso-phalangeal joints (hallux rigidus)

Exclusion Criteria:

- previous operations on the foot and ankle

- rheumatic diseases

- relevant foot deformities other than hallux rigidus

Study Design

Observational Model: Cohort


Related Conditions & MeSH terms


Intervention

Other:
Motion Analysis
3D Motion analysis with retroflective markers on the skin (Vicon camera system) of the foot and lower leg (kinematics), walking over force plate (kinetics) and pressure plates (plantar pressure distribution).

Locations

Country Name City State
Germany Motion Analysis Laboratory of the Department of Orthopedics, Trauma Surgery and Spinal Cord Injury, University Hospital Heidelberg Heidelberg

Sponsors (1)

Lead Sponsor Collaborator
University Hospital Heidelberg

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change of hallux range of motion baseline (=1 day before surgery) and 1 y. after surgery for the prospective groups, more than one year after surgery for the retrospective groups No
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