Plantar Forces Mid-term After Hemiarthroplasty With HemiCap for Hallux Rigidus

November 27, 2017 updated by: Pernille Henszelman Jørsboe, Copenhagen University Hospital, Hvidovre

The purpose of this study is to examine variabel pressure gradients of the 1st toe, 2-5th toes and the metatarsal distal caput in patients who have had surgery with a partial proximal hemiarthroplasty in the 1st metatarsalphalangeal joint (MTP) between 2006-2014.

Also, to examine these variables and compare them to the totalt range of motion and pain, to find out if the measured pedobar pressure can be used identify the well treated patient and the poorly treated patient.

The pedobar pressure gradients will be compared with a control group with healthy feet.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

41

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

  • Denmark
    • Copenhagen
      • Hvidovre, Copenhagen, Denmark, 2650
        • Hvidovre Hospital

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patient who has had an operation with proximal hemiarthroplasty (hemicap) 1st MTP proximal prosthetics 2006-2014 in Hvidovre Hospital, Glostrup Hospital or Hamlet-Aleris Hospital.

Description

Inclusion Criteria:

  • patients who has hemicap 1. MTP joint.

Exclusion Criteria:

  • patients who haad revision surgery, for example removal of hemicap and desis og 1. MTP joint.

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: Case-Control
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plantar forces under the hallux and the forefoot in patients operated with a hemiCAP in the 1st MTPJ.
Time Frame: One examination for each patient, approximately 30 min.
Plantar forces are measured under the hallux and the forefoot (plantar pressure (kPa), maximal force (N), and force/time (N/s)) is measured by the Emed foot pressure mapping system.
One examination for each patient, approximately 30 min.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Range of motion (degrees)
Time Frame: One examination for each patient, approximately 30 min.
Unit: degrees. ROM of the hemicap operated 1st MTPJ
One examination for each patient, approximately 30 min.
Level of pain
Time Frame: One examination for each patient, approximately 30 min.
Visual analog scale, 1-10 of the hemicap operated foot
One examination for each patient, approximately 30 min.

Collaborators and Investigators

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

Sponsor

Copenhagen University Hospital, Hvidovre

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 (Actual)

September 1, 2016

Primary Completion (Actual)

February 1, 2017

Study Completion (Actual)

February 1, 2017

Study Registration Dates

First Submitted

July 19, 2016

First Submitted That Met QC Criteria

September 13, 2016

First Posted (Estimate)

September 19, 2016

Study Record Updates

Last Update Posted (Actual)

November 28, 2017

Last Update Submitted That Met QC Criteria

November 27, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HEMICAP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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