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NCT03683992 · ClinicalTrials.gov registry record
Cemented vs Cementless TKA
A clinical trial, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- 147
- Enrollment target
NCT03683992 is a clinical trial that has completed, run by Washington University School of Medicine. The registered enrollment target is 147 participants.
The verdict
NCT03683992 has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- 147 participants
- Enrollment target
Study Summary
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.
Interventions
- DEVICE Triathlon total knee system
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 147 participants |
| Start Date | 2013-01-01 |
| Est. Completion | 2023-12-01 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03683992
The ClinicalTrials.gov registry entry for NCT03683992 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 147 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Triathlon total knee system is the first listed.
NCT03683992 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03683992 about?
NCT03683992 is a clinical study titled "Cemented vs Cementless TKA". 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 ...
What is the current status of trial NCT03683992?
This trial is currently completed. The enrollment target is 147 participants. The study started on 2013-01-01. Estimated completion is 2023-12-01.
What interventions are being tested in trial NCT03683992?
The interventions under investigation include: Triathlon total knee system (DEVICE).
Who is sponsoring clinical trial NCT03683992?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
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