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

Osteoarthritis of the Knee Joint Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01666873
• Other study ID #: 2012/526
• Status: Completed
• Start date: September 2012
• Est. completion date: May 2016

Study information

• Verified date: December 2014
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: May 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis of the Knee Joint
• Osteoarthritis, Knee

Intervention

Procedure:
• patients that undergo a total knee prosthesis

Locations

Country	Name	City	State
Belgium	Ghent University Hospital	Ghent

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical results after total knee prosthesis with standardized questionnaires after 6 months	Standardized questionnaires (KOOS KSS en Oxford knee score-questionnaire).	6 months after total knee prosthesis
Primary	Clinical results after total knee prosthesis with standardized questionnaires after 12 months.	Standardized questionnaires (KOOS KSS en Oxford knee score-questionnaire).	12 months after total knee prosthesis
Primary	Clinical results after total knee prosthesis with standardized questionnaires after 24 months.	Standardized questionnaires (KOOS KSS en Oxford knee score-questionnaire).	24 months after total knee prosthesis
Secondary	Alignment of lower limb, slope of lateral and medial tibial plateau, femoral slope.	imaging with 3D software (MIMICS)	6 months after total knee prosthesis

External Links

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