Comparison of the in Vivo Stability of 2 Cementless TKA Designs

Sex: All

Ages: 50 Years – 75 Years

Healthy volunteers: No

Phase: NA

Enrollment: 50

Sponsor: Helse Møre og Romsdal HF

Location: Kristiansund Hospital, Møre and Romsdal Hospital Trust Kristiansund Møre and Romsdal

Summary

The goal of this randomized controlled trial is to analyze the stability of a cementless Total Knee Arthroplasty (TKA) over time and compare it to a well-documented implant in patients with knee osteoarthritis. The main aim is to answer if there is a difference in stability over time as a measure of long time survivorship in these 2 implants. 50 participants will be randomly allocated to receive either the Triathlon Tritanium (Stryker) or the Global Medacta Knee Sphere (GMK Sphere, Medacta) 3D printed cementless TKAs.

Eligibility Criteria

Inclusion Criteria: • Patients referred to Kristiansund Hospital for primary total knee replacement surgery for osteoarthritis with Kellgren \& Lawrence grade 3 or 4 Exclusion Criteria: * Preoperative severe deformity (Hip-Knee-Ankle angle of \>5 (valgus) or \35 g/m2 * Lateral collateral ligament deficient knee * Previous knee joint infection * Cognitive dysfunction or severe psychiatric disorders.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05651009). StuddyBuddy aggregates publicly available trial information.