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

Completed

• Conditions: Osteoarthritis of the Knee Joint
• Interventions: Procedure: patients that undergo a total knee prosthesis

• Registration Number: NCT01666873
• Lead Sponsor: 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-08-14
• Study First Submitted QC: 2012-08-14
• Study First Posted: 2012-08-16
• Study Start: 2012-09
• Status Verified: 2014-12
• Primary Completion: 2016-01
• Study Completion: 2016-05
• Last Update Submitted: 2022-12-28
• Last Update Posted: 2022-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

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

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
total knee prosthesis	patients that undergo a total knee prosthesis	Patients that undergo a total knee prosthesis.

Primary Outcome Measures

Name	Time	Method
Clinical results after total knee prosthesis with standardized questionnaires after 24 months.	24 months after total knee prosthesis	Standardized questionnaires (KOOS KSS en Oxford knee score-questionnaire).
Clinical results after total knee prosthesis with standardized questionnaires after 6 months	6 months after total knee prosthesis	Standardized questionnaires (KOOS KSS en Oxford knee score-questionnaire).
Clinical results after total knee prosthesis with standardized questionnaires after 12 months.	12 months after total knee prosthesis	Standardized questionnaires (KOOS KSS en Oxford knee score-questionnaire).

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Ghent University Hospital; 🇧🇪 Ghent, Belgium