Ignite Creation Date:
2025-12-25 @ 4:36 AM
Ignite Modification Date:
2026-03-05 @ 9:00 PM
Study NCT ID:
NCT03677518
Status:
COMPLETED
Last Update Posted:
2023-05-17
First Post:
2018-09-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Total Knee Arthroplasty With the Medial-Pivot Knee System
Sponsor:
Centre Hospitalier Universitaire, Amiens
Organization:
Study Overview
Official Title:
Total Knee Arthroplasty With the Medial-Pivot Knee System: Clinicaland Radiological Outcomes at 9.5 Years' Mean Follow-up
Status:
COMPLETED
Status Verified Date:
2018-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MEDIAL-PIVOT
Brief Summary:
The "ball-in-socket" design of the Medial-Pivot knee system (MicroPort Orthopedics, Arling-ton, Tennessee, USA) aims to reproduce normal knee kinematics by medializing its rotational axis. Thegoal of this study was to measure knee range of motion (ROM) with this implant after a mean follow-up of 10 years and to report the survivorship and long-term clinical and radiological outcomes. Wehypothesized the prosthetic knee would have at least 120◦flexion at 10 years. This was retrospective, single-centre study of 74 Medial-Pivot knees implanted in71 patients (average age of 69 years) between May 2005 and November 2007. All patients who receiveda Medial-Pivot knee were included consecutively. The mean follow-up was 10 years. Clinical and radio-logical assessments were performed using the Knee Society Score (KSS) and Ewald's score. Kaplan-Meirsurvival analysis was used to calculate survivorship.
Detailed Description:
methodsThis was retrospective, single-centre study of 74 Medial-Pivotknees implanted in 71 patients between May 2005 and Novem-ber 2007. During this period, several types of semi-constrainedprimary TKA implants were used.The "ball-in-socket" design of the Medial-Pivot knee system (MicroPort Orthopedics, Arling-ton, Tennessee, USA) aims to reproduce normal knee kinematics by medializing its rotational axis. Thegoal of this study was to measure knee range of motion (ROM) with this implant after a mean follow-up of 10 years and to report the survivorship and long-term clinical and radiological outcomes. Wehypothesized the prosthetic knee would have at least 120◦flexion at 10 years. This was retrospective, single-centre study of 74 Medial-Pivot knees implanted in71 patients (average age of 69 years) between May 2005 and November 2007. All patients who receiveda Medial-Pivot knee were included consecutively. The mean follow-up was 10 years. Clinical and radio-logical assessments were performed using the Knee Society Score (KSS) and Ewald's score. Kaplan-Meirsurvival analysis was used to calculate survivorship.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: