Correlation Between Alignment of Lower Limb and Clinical Outcome After Total Knee Prosthesis.

December 28, 2022 updated by: University Hospital, Ghent

Evaluation of the clinical results after total knee prosthesis, and correlation with the alignment of the lower limb.

Radiological measurements by means of 3D technology will be performed. The clinical result will be stipulated by means of standardized questionnaires (KOOS, KSS and Oxford knee score-questionnaire).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

150

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

  • Belgium
      • Ghent, Belgium, 9000
        • Ghent University 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

People who have osteoarthritis of the knee joint and receive a total knee prosthesis.

Description

Inclusion Criteria:

  • Patient with osteoarthritis of the knee joint, without severe bone deformation

Exclusion Criteria:

  • none

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
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
total knee prosthesis
Patients that undergo a total knee prosthesis.
Procedure: patients that undergo a total knee prosthesis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical results after total knee prosthesis with standardized questionnaires after 6 months
Time Frame: 6 months after total knee prosthesis
Standardized questionnaires (KOOS KSS en Oxford knee score-questionnaire).
6 months after total knee prosthesis
Clinical results after total knee prosthesis with standardized questionnaires after 12 months.
Time Frame: 12 months after total knee prosthesis
Standardized questionnaires (KOOS KSS en Oxford knee score-questionnaire).
12 months after total knee prosthesis
Clinical results after total knee prosthesis with standardized questionnaires after 24 months.
Time Frame: 24 months after total knee prosthesis
Standardized questionnaires (KOOS KSS en Oxford knee score-questionnaire).
24 months after total knee prosthesis

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Alignment of lower limb, slope of lateral and medial tibial plateau, femoral slope.
Time Frame: 6 months after total knee prosthesis
imaging with 3D software (MIMICS)
6 months after total knee prosthesis

Collaborators and Investigators

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

Sponsor

University Hospital, Ghent

Investigators

  • Principal Investigator: Jan Victor, MD, PhD, University Hospital, Ghent

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.

Helpful Links

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, 2012

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

August 14, 2012

First Submitted That Met QC Criteria

August 14, 2012

First Posted (Estimate)

August 16, 2012

Study Record Updates

Last Update Posted (Estimate)

December 29, 2022

Last Update Submitted That Met QC Criteria

December 28, 2022

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012/526

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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