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NCT01746524 · ClinicalTrials.gov registry record
Prospective, Multiconfiguration Study to Assess Functional Performance of Primary Total Knee Arthroplasty System
A clinical trial, sponsored by DePuy Orthopaedics.
- Completed
- Registry status
- 1,138
- Enrollment target
NCT01746524 is a clinical trial that has completed, run by DePuy Orthopaedics. The registered enrollment target is 1,138 participants.
The verdict
NCT01746524 has completed, sponsored by DePuy Orthopaedics.
- COMPLETED
- Registry status
- 1,138 participants
- Enrollment target
Study Summary
This post-marketing investigation will evaluate the functional knee performance of Subjects who have undergone primary total knee arthroplasty (TKA). Data from Subjects who receive one of four contemporary knee configurations will be pooled to establish a contemporary dataset. The primary objective of this study is to evaluate the pre-operative (approximately -90 to -1 day before surgery) to minimum one year (approximately 304 to 668 days) postoperative functional performance improvement for the Attune™ primary, cemented TKA system as measured by the activities of daily living (ADL)subscore of the Knee Osteoarthritis Outcomes Score (KOOS)questionnaire (KOOS-ADL sub-score). This will be carried out for all four implant configurations: cruciate retaining fixed bearing (Attune™ CR FB), cruciate retaining rotating platform (Attune™ CR RP), posterior stabilized fixed bearing (Attune™ PS FB), and posterior stabilized rotating platform (Attune™ PS RP).
Interventions
- DEVICE ATTUNE Primary Total Knee Arthroplasty
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,138 participants |
| Start Date | 2012-11-01 |
| Est. Completion | 2018-03-05 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01746524
The ClinicalTrials.gov registry entry for NCT01746524 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 1,138 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is DePuy Orthopaedics, which has 38 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which ATTUNE Primary Total Knee Arthroplasty is the first listed.
NCT01746524 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01746524 about?
NCT01746524 is a clinical study titled "Prospective, Multiconfiguration Study to Assess Functional Performance of Primary Total Knee Arthroplasty System". This post-marketing investigation will evaluate the functional knee performance of Subjects who have undergone primary total knee arthroplasty (TKA). Data from Subjects who receive one of four contemporary knee configurations will be pooled to establish a contemporary dataset. The primary objective...
What is the current status of trial NCT01746524?
This trial is currently completed. The enrollment target is 1,138 participants. The study started on 2012-11-01. Estimated completion is 2018-03-05.
What interventions are being tested in trial NCT01746524?
The interventions under investigation include: ATTUNE Primary Total Knee Arthroplasty (DEVICE).
Who is sponsoring clinical trial NCT01746524?
This trial is sponsored by DePuy Orthopaedics, which has 38 total clinical trials registered on ClinicalTrials.gov.
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