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Total Knee Arthroplasty With the Medial-Pivot Knee System (MEDIAL-PIVOT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03677518
Recruitment Status : Completed
First Posted : September 19, 2018
Last Update Posted : September 19, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

Study Description
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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.

Condition or disease
Arthroplasty Complications

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 Design
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Study Type : Observational
Actual Enrollment : 71 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Total Knee Arthroplasty With the Medial-Pivot Knee System: Clinicaland Radiological Outcomes at 9.5 Years' Mean Follow-up
Actual Study Start Date : January 1, 2017
Actual Primary Completion Date : October 2, 2017
Actual Study Completion Date : October 2, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • patients < 18 years
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03677518


Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
Investigators
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Principal Investigator: Fabrice Mertl, MD, PhD CHU AMIENS
More Information
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Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT03677518    
Other Study ID Numbers: PI2017_843_0052
First Posted: September 19, 2018    Key Record Dates
Last Update Posted: September 19, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire, Amiens:
total knee arthroplasty
medial-pivot knee system
kinematics
survivorship