Kinematic versus mechanical alignment in knee replacement: randomized controlled double-blinded trial.

Not Applicable

Conditions: M17.1
Other primary gonarthrosis

Registration Number: DRKS00024567

Lead Sponsor: Medizinische Hochschule Hannover

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 130

Inclusion Criteria

1. Symptomatic osteoarthritis of the knee
2. Primary TKA
3. UCLA >=4
4. mMPTA: 85°-90°
5. Sum of mMPTA and mLDFA between 3° varus and 2° valgus from neutral

Exclusion Criteria

1. Pregnant or breast feeding woman
2. Difference in the radius of medial and lateral condyles >2mm
3. Previous osteotomy around the knee
4. BMI > 40
5. Ligament instability likely to require higher level of constraint
6. Previous infection or inflammatory disease
7. Any patient who cannot or will not provide informed consent for participation in the study

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The aim of this study is to compare clinical outcomes in patients receiving total knee arthroplasty with mechanical or kinematic alignment. Our hypothesis is that, two years after surgery, the outcome of the KA technique, as measured with the Knee Society Score (KSS), is different to the MA technique by more than 7.5%.

Secondary Outcome Measures

Name	Time	Method
Secondary objectives are:<br>• Evaluate functional recovery in critical motor tasks like walking downhill<br>• Evaluate patient’s ability to forget the artificial joint during activities of daily living<br>• Evaluate the perceptions of patients about total knee replacement<br>• Evaluate patient’s perception of the knee during higher levels of activity and social participation<br>• Evaluate long term knee stability and alignment by use of adduction moment in gait analysis<br>• Evaluate the effect of both therapies with reference to the pre-operative status.<br>