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NCT03683992

Cemented vs Cementless TKA

Completed Last updated 24 July 2024
What this trial tests

trial testing Triathlon total knee system in Knee Osteoarthritis in 147 participants. Completed in 1 December 2023.

Timeline
1 January 2013
Primary endpoint
1 December 2023
1 December 2023

Quick facts

Lead sponsorWashington University School of Medicine
StatusCompleted
Study typeOBSERVATIONAL
Enrollment147
Start date1 January 2013
Primary completion1 December 2023
Estimated completion1 December 2023
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Washington University School of Medicine

Who can join

Adults 18 to 75, any sex, with Knee Osteoarthritis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to compare cemented and cementless versions of the Triathlon total knee arthroplasty/replacement (TKA) in terms of clinical outcomes, perioperative course, and outcome scores including function and patient satisfaction. Patients who present to the clinical practices of Dr. Ryan Nunley, Dr. Robert Barrack, or Dr. Denis Nam and are suitable candidates for primary TKA will be screened for eligibility and invited to participate. Once enrolled participants will be randomized (1:1) to either receive a cemented or cementless Triathlon TKA. Data collected for the study will include standard of care clinical and radiographic evaluations collected during office visits and surgery, as well as study-specific patient questionnaires. Clinical, radiographic and questionnaire data will be collected pre-operatively, at the time of surgery, and at 6 weeks, 6 months, 1 year and beyond, and 2 years and beyond post-operatively. Patients will complete the following outcomes questionnaires preoperatively: New Knee Society Score, Oxford Knee Score, UCLA Activity Score, SF-12, and EQ-5D. The following questionnaires will be collected at four to six weeks, six months, one year and beyond, and two years and beyond postoperatively: New Knee Society Score, Forgotten Joint Score, Washington University Knee Satisfaction and Function Questionnaire, Oxford Knee Score, UCLA Activity Score, SF-12, and EQ-5D, and a Pain Drawing. In addition, a Pain Diary with a pain Visual Analog Scale (VAS) will be assessed once daily at home for 6 weeks after surgery.

Publications & conference data

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

  1. Cemented Versus Cementless Total Knee Arthroplasty of the Same Modern Design: A Prospective, Randomized Trial.
    Nam D, Lawrie CM, Salih R, Nahhas CR, et al · · 2019 · cited 110× · PMID 31274720 · DOI 10.2106/jbjs.18.01162
  2. A Systematic Review and Network Meta-Analysis of the Outcomes of Patients With Total Knee Arthroplasty Using Cemented, Uncemented, or Hybrid Techniques.
    Fozo ZA, Hussein Ghazal A, Kamal I, Muhe Eldeen Eshag M, et al · · 2023 · cited 9× · PMID 37869049 · DOI 10.7759/cureus.47299

Verify or expand the search:

Other recruiting trials for Knee Osteoarthritis

Currently open trials in the same condition.

Other Washington University School of Medicine 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/NCT03683992.

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