Joint Disease Clinical Trial
Official title:
A CLINICAL RANDOMIZED CONTROLLED RSA TRIAL COMPARING THE CEMENTLESS ATTUNE ROTATING PLATFORM KNEE SYSTEM TO THE CEMENTLESS LCS ROTATING PLATFORM KNEE SYSTEM
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.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT02314702 -
Post Market Clinical Follow-Up Study Protocol for PROFEMUR® L Revision Femoral Stems
|
||
| Completed |
NCT03272139 -
Interscalene Block Versus Superior Trunk Block
|
Phase 4 | |
| Completed |
NCT03271151 -
Effect of Duloxetine on Opioid Use After Total Knee Arthroplasty
|
Phase 4 | |
| Completed |
NCT01407874 -
A Randomized, Double-Blind, Dose-Response Study of the Safety and Uric Acid Effects of Oral Ulodesine Added to Allopurinol in Subjects With Gout and Concomitant Moderate Renal Insufficiency
|
Phase 2 | |
| Completed |
NCT01256216 -
Signature Versus Computer Assisted Surgery Study
|
N/A | |
| Completed |
NCT03337243 -
Effect of Implanting Allogenic Cytokines Derived From Human Amniotic Membrane (HAM) and Mesenchymal Stem Cells Derived From Human Umbilical Cord Wharton's Jelly (HUMCWJ) on Pain and Functioning of Knee Osteoarthritis
|
N/A | |
| Active, not recruiting |
NCT03294408 -
Multimodal Imaging of Subchondral Bone in Knee Osteoarthritis : Predictive Model
|
N/A | |
| Withdrawn |
NCT02668211 -
Radiostereometric Analysis (RSA) of the PROFEMUR® Preserve Classic Femoral Components
|
N/A | |
| Active, not recruiting |
NCT02239783 -
Post Market Clinical Follow-Up Study Protocol for PROFEMUR® TL Modular Femoral Stems
|
||
| Terminated |
NCT00698347 -
A Clinical Investigation of the M2a-Magnum™ Hip System
|
N/A | |
| Completed |
NCT00223353 -
Quantitative Gait Analysis for Clinical Decision Making
|
N/A | |
| Recruiting |
NCT04037735 -
RSA-RCT: Attune S+ TKA Versus Sigma TKA
|
N/A | |
| Terminated |
NCT03575975 -
3D X-ray Motion Analysis of Ankle-foot Motion After Total Ankle Arthroplasty
|
||
| Completed |
NCT03894514 -
Multi-variable Prediction Model of Total Knee Replacement Outcome
|
||
| Completed |
NCT02865447 -
Evaluation of Bone Mineral Density Changes After Total Hip Replacement: A Two-Year Clinical and DXA Analysis
|
||
| Enrolling by invitation |
NCT03576573 -
Post Market Clinical Follow-Up Study Protocol for PROCOTYL® C Acetabular Components
|
||
| Completed |
NCT02967874 -
Autologous Adipose-Derived Stromal Vascular Fraction Cells for Osteoarthritis Treatment
|
Phase 1/Phase 2 | |
| Completed |
NCT02390336 -
Mobilization With Movement in Patients With Osteoarthritis of the Hip
|
N/A | |
| Terminated |
NCT03293719 -
Post-market Follow up Study of the 'BPK-S Integration' UC as Primary Implant in the Variants CoCr or Ceramic
|
||
| Active, not recruiting |
NCT02823834 -
PMCF Study Protocol for PROFEMUR® Gladiator Plasma Femoral Stems and PROCOTYL® L Beaded Acetabular Components
|