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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: Completed study, sponsored by DePuy Orthopaedics.
NCT01746524 is a clinical trial that has completed, run by DePuy Orthopaedics. The registered enrollment target is 1,138 participants. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
The KOOS ADL will be measured before surgery and at a minimum 1 year after surgery. The KOOS is a patient self-administered questionnaire that consists of 42 questions. The KOOS consists of 5 subscales; pain, other symptoms, activities of daily living (ADL), sport and recreational function and knee-related quality of life. Each question has 5 Likert-like response options. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. The change
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 |
What the finished NCT01746524 record still lists
NCT01746524 is an observational study that tracks outcomes without assigning an intervention. Its 1,138 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 1 intervention - of which ATTUNE Primary Total Knee Arthroplasty is the first listed.
NCT01746524 does not publish any study locations in the registry export this page uses.
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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