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

This study is not yet open for participant recruitment.
Verified August 2012 by University Hospital, Ghent
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT01666873
First received: August 14, 2012
Last updated: August 16, 2012
Last verified: August 2012
History of Changes
  Purpose

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).


Condition Intervention
Osteoarthritis of the Knee Joint
 Procedure: patients that undergo a total knee prosthesis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Correlation Between Alignment of Lower Limb and Clinical Outcome After Total Knee Prosthesis.

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • Clinical results after total knee prosthesis with standardized questionnaires after 6 months [ Time Frame: 6 months after total knee prosthesis ] [ Designated as safety issue: No ]
    Standardized questionnaires (KOOS KSS en Oxford knee score-questionnaire).

  • Clinical results after total knee prosthesis with standardized questionnaires after 12 months. [ Time Frame: 12 months after total knee prosthesis ] [ Designated as safety issue: No ]
    Standardized questionnaires (KOOS KSS en Oxford knee score-questionnaire).

  • Clinical results after total knee prosthesis with standardized questionnaires after 24 months. [ Time Frame: 24 months after total knee prosthesis ] [ Designated as safety issue: No ]
    Standardized questionnaires (KOOS KSS en Oxford knee score-questionnaire).


Secondary Outcome Measures:
  • Alignment of lower limb, slope of lateral and medial tibial plateau, femoral slope. [ Time Frame: 6 months after total knee prosthesis ] [ Designated as safety issue: No ]
    imaging with 3D software (MIMICS)


Estimated Enrollment: 150
Study Start Date: September 2012
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
total knee prosthesis
Patients that undergo a total knee prosthesis.
 Procedure: patients that undergo a total knee prosthesis

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • none
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01666873

Contacts
Contact: Jan Victor, MD, PhD Jan.Victor@ugent.be

Locations
Belgium
Ghent University Hospital Not yet recruiting
Ghent, Belgium, 9000
Contact: Jan Victor, MD, PhD         Jan.Victor@ugent.be    
Principal Investigator: Jan Victor, MD, PhD            
Sub-Investigator: Dimitri Verbruggen            
Sponsors and Collaborators
University Hospital, Ghent
Investigators
Principal Investigator: Jan Victor, MD, PhD Ghent University Hospital
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT01666873     History of Changes
Other Study ID Numbers: 2012/526
Study First Received: August 14, 2012
Last Updated: August 16, 2012
Health Authority: Belgium: Ethics Committee

Keywords provided by University Hospital, Ghent:
osteoarthritis

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on June 17, 2013