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NCT03101007: ALKNEE
RSA RCT: Attune RP TKA Versus LCS RP TKA
NA trial testing ATTUNE Knee Prosthesis by DePuy in Osteoarthritis Arthritis in 61 participants. Completed in 5 June 2021.
5 June 2021
Quick facts
| Lead sponsor | Spaarne Gasthuis |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 61 |
| Start date | 25 July 2017 |
| Primary completion | 5 June 2021 |
| Estimated completion | 5 June 2021 |
| Sites | 2 locations across Netherlands |
Drugs / interventions tested
- ATTUNE Knee Prosthesis by DePuy
- LCS Knee Prosthesis by DePuy
Conditions studied
- Osteoarthritis Arthritis — all drugs for Osteoarthritis Arthritis →
- Joint Disease — all drugs for Joint Disease →
- Musculoskeletal Disease — all drugs for Musculoskeletal Disease →
Sponsor
Spaarne Gasthuis — full company profile →
Who can join
Adults 21 to 90, any sex, with Osteoarthritis Arthritis or Joint Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The LCS Complete Cementless Knee by DePuy Synthes is a rotating platform knee replacement with a good clinical track record and good survival rates. The cementless ATTUNE Cruciate Sacrificing (CS) Rotating Platform Knee by DePuy Synthes has been designed to provide better range of motion and address the unstable feeling some patients experience during everyday activities, such as stair descent and bending. It is expected that the cementless ATTUNE Rotating Platform Knee will have regulatory approval early 2016. Patient inclusion will start after regular approval has been obtained. The objective of this study is to accurately assess and compare migration, clinical and radiological outcome and patient reported outcomes (PROMS) of two TKR prostheses: the Cementless ATTUNE Rotating Platform Cruciate Sacrificing Knee System and the LCS Complete Cementless Cruciate Sacrificing Knee System (rotating platform design), both by DePuy Synthes, Warsaw, Indiana, USA. In this single-blind, randomized non-inferiority trial, 32 patients with the ATTUNE Knee System and 32 patients with LCS Knee System will be included. The study population will consist of patients with symptomatic osteoarthritis of the knee scheduled for TKR surgery at the Department of Orthopaedics, Spaarne Gasthuis, Hoofddorp, The Netherlands. Annually 300 TKA procedures are performed in this department, of which about 95% is Osteo Arthritis (OA). The investigator anticipates that inclusion can be accomplished within a 1 year period and that the total study duration is 3 years. Main study parameters/endpoints are: * Migration, measured by means of RSA. * Patient Reported Outcome Measures by means of questionnaires.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03101007
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Osteoarthritis Arthritis
Currently open trials in the same condition.
- NCT04037735 — RSA-RCT: Attune S+ TKA Versus Sigma TKA · NA · recruiting
Other Spaarne Gasthuis trials
Trials by the same sponsor.
- NCT06235957 — Three Weeks of Cast Immobilisation Versus One Week of Brace Immobilisation in Distal Radius Fractures · NA · not yet recruiting
- NCT06157229 — Multifactorial Approach Training for Anterior Shoulder Instability in Patients Undergoing Arthroscopic Bankart Repair · NA · not yet recruiting
- NCT06016244 — Safe, Effective and Cost-Effective Oxygen Saturation Targets for Children and Adolescents With Respiratory Distress: a R · NA · unknown
- NCT05906186 — Study Intestinal Complaints During Chemotherapy. · unknown
- NCT05926921 — Musical Intervention During IV-line Placement in Neonates · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03101007 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Spaarne Gasthuis
- Last refreshed: 27 April 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03101007.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing