Total Knee Arthroplasty With the Medial-Pivot Knee System

NCT03677518 | Completed

• 1 other identifier: PI2017_843_0052
• Study Type: observational
• Target: 71
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Arthroplasty Complications

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Flexion with an Advance® Medial-Pivot knee

  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.

  2years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The patients were operated by four experienced surgeons usingthe same protocol. A mid-line skin incision was made in all patientsexcept one who had previously undergone a lateral osteotomy. The parapatellar arthrotomy was medial in all cases. Independent tibialand femoral cuts were made with an intramedullary femoral aim-ing device targeting 7◦valgus in 48 cases and 5◦in 2 cases. Femoral component external rotation of 3◦relative to the posterior condy-lar plane was applied in all patients. All implants were fixed usingPalacos®bone cement with gentamicin (Haeraus, Warsaw, USA).The patella was resurfaced in 40 knees.

You may qualify if:

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

You may not qualify if:

• patients \< 18 years

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Officials

• Fabrice Mertl, MD, PhD

  CHU AMIENS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2018
• First Posted: September 19, 2018
• Study Start: January 1, 2017
• Primary Completion: October 2, 2017
• Study Completion: October 2, 2017
• Last Updated: May 17, 2023

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share