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NCT05651009: ClessTKA

Comparison of the in Vivo Stability of 2 Cementless TKA Designs

Active, enrolled NA Last updated 27 August 2024
What this trial tests

NA trial testing TKA in Knee Osteoarthritis in 50 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline
6 December 2022
Primary endpoint
25 June 2028
1 January 2033

Quick facts

Lead sponsorHelse Møre og Romsdal HF
PhaseNA
StatusActive, enrolled
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment50
Start date6 December 2022
Primary completion25 June 2028
Estimated completion1 January 2033
Sites1 location across Norway

Drugs / interventions tested

Conditions studied

Sponsor

Helse Møre og Romsdal HF — full company profile →

Who can join

Adults 50 to 75, any sex, with Knee Osteoarthritis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Computed tomography-based radiostereometric analysis achieves sufficient precision for femoral implants in total knee arthroplasty: a randomized controlled trial.
    Øhrn FD, Engseth LHW, Pripp AH, Frøseth Aae T, et al · · 2025 · cited 1× · PMID 41316419 · DOI 10.1186/s13018-025-06517-1
  2. Dose reduction does not impact precision of CT-RSA in tibial components in total knee arthroplasty: a randomized controlled trial.
    Bru F, Engseth LHW, Pripp AH, Schulz A, et al · · 2026 · PMID 41840645 · DOI 10.1186/s13018-026-06801-8

Verify or expand the search:

Other trials of TKA

Trials testing the same drug.

Other recruiting trials for Knee Osteoarthritis

Currently open trials in the same condition.

Other Helse Møre og Romsdal HF trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05651009.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing