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NCT02839850 · ClinicalTrials.gov registry record · NA
14022 ATTUNE Cementless RP Clinical Performance Evaluation
A NA study of Osteoarthritis, sponsored by DePuy Orthopaedics.
- Active
- Registry status
- NA
- Development phase
- 540
- Enrollment target
- 20
- Study locations
NCT02839850: Active NA study of Osteoarthritis, sponsored by DePuy Orthopaedics.
NCT02839850 is a NA study of Osteoarthritis that is active but no longer recruiting, run by DePuy Orthopaedics. The registered enrollment target is 540 participants, below the 814-participant average among 135 other Osteoarthritis trials with a reported enrollment target (34% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02839850, a NA study of Osteoarthritis, is active but no longer recruiting, sponsored by DePuy Orthopaedics.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 540 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary objective of this study is to examine the change from pre-operative baseline to two year postoperative functional performance improvement for the ATTUNE primary, cementless TKA RP system as measured with the KOOS questionnaire (KOOS-ADL sub-score). This will be carried out for two configurations: cruciate retaining rotating platform (ATTUNE Cementless CR RP) and posterior stabilized rotating platform (ATTUNE Cementless PS RP).
Primary Outcome
The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient self-administered questionnaire that consists of 42 questions and include the WOMAC Osteoarthritis index. 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.
Conditions Studied
Interventions
- DEVICE Cementless Total Knee Arthroplasty
Study Locations (20)
Other
- Sevice de Chirurgie Orthoedique et Traumatologique - Salouël
- Klinikum Garmisch-Partenkirchen GmbH - Garmisch-Partenkirchen
- South Infirmary Victoria University Hospital - Cork
- University of Otago - Christchurch
- Nottingham University Hospitals NHS Trust - Nottingham
New Hampshire
- Dartmouth-Hitchcock Medical Center - Lebanon
- New London Hospital - New London
Colorado
- Colorado Joint Replacement - Denver
Florida
- Florida Research Associates - DeLand
New Jersey
- Rothman Institute - Egg Harbor
New York
- SUNY downstate Medical Center - Brooklyn
North Carolina
- UNC Chapel Hill - Chapel Hill
Tennessee
- Associated Orthopaedics of Kingsport - Kingsport
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 540 participants |
| Start Date | 2016-09-01 |
| Est. Completion | 2027-09-01 |
| Phase | NA |
What the registry record for NCT02839850 still lists
NCT02839850 is an interventional study that assigns participants to a tested intervention. The registered 540 participants enrollment target is mid-sized for trials with a published cap, below the 814-participant average among 135 other Osteoarthritis trials with a reported enrollment target (34% lower).
The record links to 1 condition, with Osteoarthritis appearing as the primary indexed condition, and to 1 intervention - of which Cementless Total Knee Arthroplasty is the first listed.
NCT02839850 names 20 study sites across 15 states, led by Other, New Hampshire, Colorado.
Frequently Asked Questions
What is clinical trial NCT02839850 about?
NCT02839850 is a clinical study titled "14022 ATTUNE Cementless RP Clinical Performance Evaluation". The primary objective of this study is to examine the change from pre-operative baseline to two year postoperative functional performance improvement for the ATTUNE primary, cementless TKA RP system as measured with the KOOS questionnaire (KOOS-ADL sub-score). This will be carried out for two config...
What is the current status of trial NCT02839850?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 540 participants. The study started on 2016-09-01. Estimated completion is 2027-09-01.
What conditions does trial NCT02839850 study?
This clinical trial studies the following conditions: Osteoarthritis.
What interventions are being tested in trial NCT02839850?
The interventions under investigation include: Cementless Total Knee Arthroplasty (DEVICE).
Who is sponsoring clinical trial NCT02839850?
This trial is sponsored by DePuy Orthopaedics, which has 38 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02839850 being conducted?
This trial has 20 study locations across Colorado, Florida, New Hampshire, New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02839850's enrollment target sits among peer trials
540 26th of 135 higher than 110 of 135 other Osteoarthritis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Osteoarthritis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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