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Clinical Trials/NCT03677518
NCT03677518
Completed
Not Applicable

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

Centre Hospitalier Universitaire, Amiens0 sites71 target enrollmentJanuary 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Arthroplasty Complications
Sponsor
Centre Hospitalier Universitaire, Amiens
Enrollment
71
Primary Endpoint
Flexion with an Advance® Medial-Pivot knee
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2017
End Date
October 2, 2017
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • patients \< 18 years

Outcomes

Primary Outcomes

Flexion with an Advance® Medial-Pivot knee

Time Frame: 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.

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