Joint Diseases Clinical Trial
Official title:
Post Market Clinical Follow-Up Study for EVOLUTION® Revision Tibial System and EVOLUTION® Stemmed CS Femur With the EVOLUTION® MP CS Tibial Insert
MicroPort (MPO) is conducting this PMCF study to evaluate the safety and effectiveness of its EVOLUTION® Revision Tibial System and EVOLUTION® Revision STEMMED CS Femur with the EVOLUTION® MP CS Tibial Insert. This type of study is required by regulatory authorities for all devices that have been approved in Europe to evaluate the medium and long-term clinical evidence.
The primary objective of this study is to estimate individual component survivorship for tibial base, femoral component, and tibial insert at specified intervals out to 10 years follow-up. The secondary objectives include: - Determine the cumulative incidence of individual component revision at specified intervals out to 10 years follow-up; - Characterize functional scores for subjects, as assessed by KOOS Scores and EQ-5D-5L Scores, out to 10 years follow-up; - To assess subject satisfaction with their TKA procedure using the Forgotten Joint Score and a Satisfaction Survey; - To assess the presence, zone, and the size of radiolucencies surrounding implanted components out to 10 years follow-up; - To assess safety and characterize protocol defined adverse events and adverse device effects. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Withdrawn |
NCT04976972 -
A Comparison of Patients Receiving a Total Knee Replacement With Robotic Assistance or With Conventional Instrumentation
|
N/A | |
| Not yet recruiting |
NCT03726788 -
Intra Articular Injection of Botulinum Toxin Versus Corticoids in Gonarthrosis
|
Phase 2 | |
| Completed |
NCT02944448 -
A Study Evaluating Pain Relief and Safety of Orally Administered CR845 in Patients With Osteoarthritis of Hip or Knee
|
Phase 2 | |
| Completed |
NCT02604446 -
Depot-opioids for Pre- and Postoperative Pain Relief After Primary Knee Arthroplasty.Tapentadol vs Oxycodone vs Placebo
|
Phase 3 | |
| Completed |
NCT02256098 -
RSA RCT: ATTUNE™ TKA Versus PFC Sigma TKA
|
N/A | |
| Completed |
NCT02269254 -
Persona Versus NexGen
|
N/A | |
| Completed |
NCT00815243 -
Telemedicine Consultation in Trauma and Orthopedic
|
N/A | |
| Recruiting |
NCT05564182 -
High Intensity Laser Therapy in the Treatment of Hemiplegic Shoulder Pain
|
N/A | |
| Enrolling by invitation |
NCT04147559 -
Post Market Clinical Follow-Up Study for PROFEMUR® Preserve Classic Femoral Stem
|
||
| Terminated |
NCT02591368 -
MiniTightRope Suspensionplasty Compared With LRTI for the Treatment of Basilar Thumb Arthritis
|
N/A | |
| Completed |
NCT01227694 -
Adult Stem Cell Therapy for Repairing Articular Cartilage in Gonarthrosis
|
Phase 1/Phase 2 | |
| Completed |
NCT00784277 -
A Study to Compare the Frequency of Constipation Symptoms With Tapentadol Immediate Release (IR) Treatment Versus Oxycodone IR Treatment in Patients With End-stage Joint Disease
|
Phase 3 | |
| Active, not recruiting |
NCT05618782 -
Clinical Trial to Evaluate the Efficacy and Safety of LEVI-04 in Patients With Osteoarthritis of the Knee
|
Phase 2 | |
| Recruiting |
NCT04029792 -
Evaluation of a Combination of Plant Extracts (BSL_EP028) on Joint Mobility
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT06404346 -
Comparative Effectiveness of HVT and Bowen Technique in Patients of SI Joint Dysfunction With Upslipped Innominates
|
N/A | |
| Terminated |
NCT04712019 -
Evaluating Edema and Range of Motion Using Negative Pressure Therapy vs. Standard Surgical Dressing in Bilateral TKA
|
N/A | |
| Completed |
NCT05650970 -
Radial Nerve Mobilization in Hand Thumb Osteoarthritis Patients
|
N/A | |
| Recruiting |
NCT06074744 -
Subsartorial Nerve Block and Femoral Nerve Block in Total Knee Arthroplasty
|
N/A | |
| Completed |
NCT02315664 -
MONITOR-OA: Using Wearable Activity Trackers to Improve Physical Activity in Knee Osteoarthritis
|
N/A | |
| Completed |
NCT05241691 -
Retrospective Evaluation of GGPSP's Safety and Clinical Performance for the Treatment of Lower Limbs Deformities.
|