14022 ATTUNE Cementless RP Clinical Performance Evaluation
Condition(s) studied
Investigational drug(s) / intervention(s)
Cementless Total Knee Arthroplasty: Patients will undergo a primary total knee replacement using one of the two configurations of the ATTUNE Cementless knee (CR RP or PS RP)
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).
Eligibility
Primary outcome measure(s)
- Patient-reported Outcome: Knee Injury and Osteoarthritis Outcome Score Activities of Daily Living (KOOS ADL) — Minimum 2 years (670-1033 days after surgery)
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.
Trial sites (20)
| Facility | City | Region | Status |
|---|---|---|---|
| Colorado Joint Replacement | Denver | Colorado | |
| Florida Research Associates | DeLand | Florida | |
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | |
| New London Hospital | New London | New Hampshire | |
| Rothman Institute | Egg Harbor | New Jersey | |
| SUNY downstate Medical Center | Brooklyn | New York | |
| UNC Chapel Hill | Chapel Hill | North Carolina | |
| Associated Orthopaedics of Kingsport | Kingsport | Tennessee | |
| Texas Tech University Heath Science Center | Lubbock | Texas | |
| Hampton Roads Orthopaedics and Sports Medicine | Newport News | Virginia | |
| Krankenhaus der Barmherzigen Schwestern Ried im Innkreis | Ried im Innkreis | Upper Austria | |
| Foothills Medical Centre, University of Calgary | Calgary | Alberta | |
| CHU de la Cavale Blanche | Brest | Cedex | |
| Sevice de Chirurgie Orthoedique et Traumatologique | Salouël | France | |
| Klinikum Garmisch-Partenkirchen GmbH | Garmisch-Partenkirchen | Germany | |
| South Infirmary Victoria University Hospital | Cork | Ireland | |
| Elkerliek Ziekenhuis | Helmond | North Brabant | |
| University of Otago | Christchurch | New Zealand | |
| Wrightington Hospital | Wigan | Lancashire | |
| Nottingham University Hospitals NHS Trust | Nottingham | United Kingdom |
More DePuy Orthopaedics trials in the UK
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT02839850 on ClinicalTrials.gov ↗ ← All trials in the UK