NCT01804491

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2006

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

March 1, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 5, 2013

Completed
Last Updated

March 5, 2013

Status Verified

March 1, 2013

Enrollment Period

2.8 years

First QC Date

March 1, 2013

Last Update Submit

March 1, 2013

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (7)

Control group

Healthy age matched control subjects

Other: Motion Analysis

Cheilectomy prospective group

Patients with hallux rigidus treated by the surgery type "cheilectomy"

Other: Motion Analysis

Arthrodesis prospective group

Patients with hallux rigidus treated by the type of surgery "arthrodesis"

Other: Motion Analysis

Mixed prospective group

Patients with hallux rigidus treated by other type of surgery: Arthoplasty, joint resection ("Keller-Brandes technique)

Other: Motion Analysis

Cheilectomy retrospective group

Patients after cheilectomy due to hallux rigidus

Other: Motion Analysis

Arthrodesis retrospective group

Patients after arthrodesis of the metatarsophalageal joint due to hallux rigidus

Other: Motion Analysis

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

Interventions

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 groupArthrodesis retrospective groupCheilectomy prospective groupCheilectomy retrospective groupControl groupMixed prospective groupMixed retrospective group

Eligibility Criteria

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

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

You may qualify if:

  • 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)

You may not qualify if:

  • previous operations on the foot and ankle
  • rheumatic diseases
  • relevant foot deformities other than hallux rigidus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Heidelberg, 69118, Germany

Location

Related Publications (1)

  • Kuni B, Wolf SI, Zeifang F, Thomsen M. Foot kinematics in walking on a level surface and on stairs in patients with hallux rigidus before and after cheilectomy. J Foot Ankle Res. 2014 Feb 13;7(1):13. doi: 10.1186/1757-1146-7-13.

MeSH Terms

Conditions

Hallux Rigidus

Condition Hierarchy (Ancestors)

Foot Deformities, AcquiredFoot DeformitiesMusculoskeletal DiseasesJoint Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Orthopedic and Trauma Surgeon

Study Record Dates

First Submitted

March 1, 2013

First Posted

March 5, 2013

Study Start

October 1, 2006

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

March 5, 2013

Record last verified: 2013-03

Locations