NCT03130309

Brief Summary

The unicompartmental knee prosthesis 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 unicompartmental knee prosthesis with mobile plate for over 10 years, with the ones published in the literature for conventional fixed-bearing prostheses and mobile-bearing prostheses

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 21, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 26, 2017

Completed
5 days until next milestone

Study Start

First participant enrolled

May 1, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

April 26, 2018

Status Verified

April 1, 2017

Enrollment Period

1 year

First QC Date

April 21, 2017

Last Update Submit

April 25, 2018

Conditions

Knee Replacement

Keywords

KneeReplacementMobile-bearingunicompartmental prosthesis

Outcome Measures

Primary Outcomes (1)

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

    10 years

Eligibility Criteria

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

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

You may qualify if:

  • Patients over 18 years
  • Patients wearing unicompartmental 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 Sites (1)

Centre de Chirurgie Orthopédique et de la Main (CCOM)

Strasbourg, 67091, France

RECRUITING

Study Officials

  • Jean-Yves JENNY, MD, PhD

    University Hospital, Strasbourg, France

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean-Yves JENNY, MD, PhD

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

April 21, 2017

First Posted

April 26, 2017

Study Start

May 1, 2017

Primary Completion

May 1, 2018

Study Completion

May 1, 2018

Last Updated

April 26, 2018

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)