Total Knee Arthroplasty With the Medial-Pivot Knee System

Total Knee Arthroplasty With the Medial-Pivot Knee System: Clinicaland Radiological Outcomes at 9.5 Years' Mean Follow-up

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03677518

Acronym

MEDIAL-PIVOT

Enrollment

Registered

2018-09-19

Start date

2017-01-01

Completion date

2017-10-02

Last updated

2026-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthroplasty Complications

Keywords

total knee arthroplasty, medial-pivot knee system, kinematics, survivorship

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* patients \> 18 years * patienst must be operated * patient with mid-line skin incision

Exclusion criteria

* patients \< 18 years

Design outcomes

Primary

Measure	Time frame	Description
Flexion with an Advance® Medial-Pivot knee	2years	The objective of this study was to evaluate the flexion in patients with an Advance® Medial-Pivot knee after an average follow-upof 10 years. Knee flexion was measured with a goniometer in the office; thegreater trochanter, knee centre and lateral malleolus were used asreference points.

Countries

France

Contacts

PRINCIPAL_INVESTIGATORFabrice Mertl, PU-PH

CHU Amiens-Picardie

Outcome results