Status:

ACTIVE_NOT_RECRUITING

Kinematic Versus Mechanical Alignment in Total Knee Replacement

Lead Sponsor:

Hannover Medical School

Conditions:

Total Knee Replacement

Eligibility:

All Genders

18+ years

Brief Summary

This prospective controlled double-blind randomized study compares kinematic and mechanical alignment in TKA (Total knee arthroplasty). A total of 120 patients will be included and the surgery will be...

Detailed Description

Total knee arthroplasty (TKA) is known, to significantly improve function and satisfaction in arthritic knee patients; nevertheless, a substantial percentage of these patients are not fully satisfied....

Eligibility Criteria

Inclusion

  • Symptomatic osteoarthritis of the knee
  • Primary TKA
  • UCLA Score (University of California, Los Angeles Score)\>/= 4
  • mMPTA: 85°- 90°
  • Sum of mMPTA(mechanical medial proximal tibial angle) and mLDFA(mechanical lateral distal femoral angle) between 3°varus and 2°valgus from neutral

Exclusion

  • Minor Patient
  • Pregnant or breast feeding woman
  • Difference in the radius of medial and lateral condyles \>2mm
  • Previous osteotomy around the knee
  • BMI \>40
  • Ligament instability likely to require higher level of constraint
  • Previous infection or inflammatory disease
  • Any Patient who cannot or will not provide informed consent for participation in the study

Key Trial Info

Start Date :

August 1 2017

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

January 30 2026

Estimated Enrollment :

130 Patients enrolled

Trial Details

Trial ID

NCT04384913

Start Date

August 1 2017

End Date

January 30 2026

Last Update

March 25 2025

Active Locations (1)

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Orthopädische Klinik der Medizinischen Hochschule Hannover im DIAKOVERE Annastift

Hanover, Lower Saxony, Germany, 30625