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Clinical Trials in Germany / NCT04384913
Active, not recruiting Observational

Kinematic Versus Mechanical Alignment in Total Knee Replacement

NCT04384913 · tracked via the Priya Life Science Germany tracker
Sponsor
Hannover Medical School
Phase
Observational
Started
2017-08-01
Last updated
2025-03-25

Condition(s) studied

Total Knee Replacement

Study 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 performed using CT based 3D printed PSI(Patient Specific Instruments) Cutting guides.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 Criteria: * 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

Primary outcome measure(s)

  • Knee Society Score (KSS) — 3 months postoperative
    The Knee Society Scoring System is a validated and responsive method for assessing objective and subjective outcomes after total and partial knee arthroplasty. Minimum: 0 (worst), Maximum: 100 (best)
  • Knee Society Score (KSS) — 12 months postoperative
    The Knee Society Scoring System is a validated and responsive method for assessing objective and subjective outcomes after total and partial knee arthroplasty. Minimum: 0 (worst), Maximum: 100 (best)
  • Knee Society Score (KSS) — 24 months postoperative
    The Knee Society Scoring System is a validated and responsive method for assessing objective and subjective outcomes after total and partial knee arthroplasty. Minimum: 0 (worst), Maximum: 100 (best)

Trial sites (1)

FacilityCityRegionStatus
Orthopädische Klinik der Medizinischen Hochschule Hannover im DIAKOVERE Annastift Hanover Lower Saxony

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Other trials for the same condition

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04384913 on ClinicalTrials.gov ↗ ← All trials in Germany