Prospective, Multiconfiguration Study to Assess Functional Performance of Primary Total Knee Arthroplasty System
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This page only displays public information reproduced from the official ClinicalTrials.gov record NCT01746524. It adds no medical advice, opinions, or eligibility judgments. The official record remains the source of truth for eligibility criteria, enrollment, and contact information.
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Official title
Prospective, Single Arm Multiconfiguration Investigation to Assess Functional Performance of Attune™ Primary Total Knee Arthroplasty System
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT01746524
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 1,138 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 22 Years to 80 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 1, 2012 (Actual)
- Primary completion
- Mar 5, 2018 (Actual)
- Completion
- Mar 5, 2018 (Actual)
- Last update posted
- Apr 11, 2019
2012 – 2018
United States locations
- U.S. sites
- 9
- U.S. states
- 8
- U.S. cities
- 9
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Orthopaedic Specialty Institute | Orange | California | 92868 | — |
| UCSD Medical Center | San Diego | California | 92103 | — |
| Orhopaedic Center of the Rockies | Fort Collins | Colorado | 80525 | — |
| The Arthroplasty Foundation | Louisville | Kentucky | 40215 | — |
| Hip and Knee Research of Nevada | Las Vegas | Nevada | 89128 | — |
| Dartmouth Medical School/Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03765 | — |
| Cardinal Orthopaedic Institute | Columbus | Ohio | 43213 | — |
| Anderson Orthopaedic Research Institute | Alexandria | Virginia | 22307 | — |
| Swedish Orthopedic Institute | Seattle | Washington | 98122 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 11 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01746524, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 11, 2019 · Synced Nov 15, 2026
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