NCT02651571

Brief Summary

The total knee replacement has become a routine procedure. Survival rate of over 90% after 10 years are generally reported. However, complications and reoperation may still occur for many reasons, and some of them may be related to component design: loosening (tibial above), polyethylene wear, knee stiffness, ligamentous instability, etc ... . Therefore, new designs can, at least in theory, improve the results of conventional models. In this study, the investigators want to compare retrospectively data concerning survival rates of patients wearing total knee prosthesis with mobile plate for over 10 years, with the ones published in the literature for conventional fixed-bearing prostheses.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2016

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 4, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 11, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

June 17, 2016

Status Verified

January 1, 2016

Enrollment Period

1 year

First QC Date

January 4, 2016

Last Update Submit

June 16, 2016

Conditions

Knee Replacement

Keywords

KneeReplacementProsthesisMobile-bearing

Outcome Measures

Primary Outcomes (1)

  • Compare retrospectively data concerning survival rates of patients wearing total knee prosthesis with mobile plate for over 10 years, with the ones published in the literature for conventional fixed-bearing prostheses.

    10 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients wearing total knee prosthesis with mobile plate for over 10 years

You may qualify if:

  • Patients over 18 years
  • Patients wearing total knee prosthesis with mobile plate for over 10 years

You may not qualify if:

  • Patients under 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Jean-Yves JENNY, MD

    University Hospital, Strasbourg, France

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean-Yves JENNY, MD

CONTACT

33.3.88.55.21.45jean-yves.jenny@chru-strasbourg.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2016

First Posted

January 11, 2016

Study Start

March 1, 2016

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

June 17, 2016

Record last verified: 2016-01

Data Sharing

IPD Sharing
Will not share