MedTrace Logo

Comparison of the in Vivo Stability of 2 Cementless TKA Designs

NCT05651009 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-08-27

No results posted yet for this 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.

Conditions

Interventions

PROCEDURE

TKA

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

Sponsors & Collaborators

  • Oslo University Hospital

    collaborator OTHER

  • Medacta International SA

    collaborator INDUSTRY

  • Helse Møre og Romsdal HF

    lead OTHER_GOV

Principal Investigators

  • Frank-David Øhrn, MD, PhD · Møre og Romsdal Hospital Trust

  • Stephan M Röhrl, MD, PhD · Oslo University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-06
Primary Completion
2028-06-25
Completion
2033-01-01

Countries

  • Norway

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05651009 on ClinicalTrials.gov