Motion Analysis in Patients With Hallux Rigidus

March 1, 2013 updated by: Dr. med. Benita Kuni, MD, University Hospital Heidelberg

Motion Analysis in Patients With Hallux Rigidus Before and After Different Types of Surgery

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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).

Study Type

Observational

Enrollment (Actual)

56

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Heidelberg, Germany, 69118
        • Motion Analysis Laboratory of the Department of Orthopedics, Trauma Surgery and Spinal Cord Injury, University Hospital Heidelberg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with osteoarthritis in the first metatarso-phalangeal joint (hallux rigidus)

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control group
Healthy age matched control subjects
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).
Cheilectomy prospective group
Patients with hallux rigidus treated by the surgery type "cheilectomy"
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).
Arthrodesis prospective group
Patients with hallux rigidus treated by the type of surgery "arthrodesis"
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).
Mixed prospective group
Patients with hallux rigidus treated by other type of surgery: Arthoplasty, joint resection ("Keller-Brandes technique)
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).
Cheilectomy retrospective group
Patients after cheilectomy due to hallux rigidus
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).
Arthrodesis retrospective group
Patients after arthrodesis of the metatarsophalageal joint due to hallux rigidus
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).
Mixed retrospective group
Patients after other types of surgery due to hallux rigidus: arthroplasty or resection of the first metatarso-phalangeal joint
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change of hallux range of motion
Time Frame: baseline (=1 day before surgery) and 1 y. after surgery for the prospective groups, more than one year after surgery for the retrospective groups
baseline (=1 day before surgery) and 1 y. after surgery for the prospective groups, more than one year after surgery for the retrospective groups

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Heidelberg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

March 1, 2013

First Submitted That Met QC Criteria

March 1, 2013

First Posted (Estimate)

March 5, 2013

Study Record Updates

Last Update Posted (Estimate)

March 5, 2013

Last Update Submitted That Met QC Criteria

March 1, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 252-2006-130228

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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