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Clinical Trials in Norway / NCT05651009
Active, not recruiting Not applicable

Comparison of the in Vivo Stability of 2 Cementless TKA Designs

NCT05651009 · tracked via the Priya Life Science Norway tracker
Sponsor
Helse Møre og Romsdal HF
Phase
Not applicable
Started
2022-12-06
Last updated
2026-08-17

Condition(s) studied

Knee Osteoarthritis

Investigational drug(s) / intervention(s)

TKA

TKA: Total knee artroplasty with medial parapatellar incision and mechanical alignment without navigation

Study 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

Sex
ALL
Min age
50 Years
Max age
75 Years
Healthy volunteers
No
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 \<-15 degrees (varus) on a full-length leg image at weight bearing * Preoperative flexion contracture more than 15° * Less than 50 and more than 75 years of age at the time of surgery * Use of walking aids because of other musculoskeletal and neuromuscular problems * Preoperative diagnosis other than osteoarthritis or avascular necrosis (e.g. rheumatoid arthritis, tumours) * Revision arthroplasty * Obesity with BMI\>35 g/m2 * Lateral collateral ligament deficient knee * Previous knee joint infection * Cognitive dysfunction or severe psychiatric disorders.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Kristiansund Hospital, Møre and Romsdal Hospital Trust Kristiansund Møre and Romsdal

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Other trials for the same condition

Prehabilitation Effect on Function and Patient Satisfaction Following Total Knee Arthroplasty Recruiting
Ligament Balancing in Total Knee Arthroplasty Recruiting
The personalKNEE Trial Recruiting
Daycase Hip and Knee Arthroplasty in Møre and Romsdal Trial Starting soon
Effect of an Information- and Self-management App for People With Knee Osteoarthritis Recruiting
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 NCT05651009 on ClinicalTrials.gov ↗ ← All trials in Norway