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

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ClinicalTrials.gov Identifier: NCT01666873
Recruitment Status : Unknown
Verified December 2014 by University Hospital, Ghent.
Recruitment status was:  Recruiting
First Posted : August 16, 2012
Last Update Posted : December 5, 2014
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent

Brief Summary:

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 or disease Intervention/treatment
Osteoarthritis of the Knee Joint Procedure: patients that undergo a total knee prosthesis

Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Correlation Between Alignment of Lower Limb and Clinical Outcome After Total Knee Prosthesis.
Study Start Date : September 2012
Estimated Primary Completion Date : January 2016
Estimated Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

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



Primary Outcome Measures :
  1. 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).

  2. 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).

  3. 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).


Secondary Outcome Measures :
  1. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01666873


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

Locations
Belgium
Ghent University Hospital 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 University Hospital, Ghent

Additional Information:
Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT01666873     History of Changes
Other Study ID Numbers: 2012/526
First Posted: August 16, 2012    Key Record Dates
Last Update Posted: December 5, 2014
Last Verified: December 2014

Keywords provided by University Hospital, Ghent:
osteoarthritis

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