Results of Unicompartmental Knee Arthroplasties in Patients Beyond Historical Indications (PUCIL) (PUCIL)

March 1, 2023 updated by: FERNANDEZ Andrea, Central Hospital, Nancy, France

Unicompartimental Knee Arthroplasties When Borders Are Crossed : Survival Study at 7 Years

Primary objective:

To compare medial uni compartimental knee arthroplasty between patients who had a limit factor prior to the surgery ans patients who fill thé historical criteria.

Secondary objectives

1 to compare survival of medial UKA between patients with one limit factor and those with multiple limits.

2. To identify the prognosis factors of failure in medial UKA in our center during the time of our analysis (2009-2015)

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

7 year follow up survival if no amputation or no removal of UKA for TKA

Study Type

Observational

Enrollment (Anticipated)

522

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All medial UKA implanted between 2009 and 2015 at the CCEG with follow up at 7 years

Description

Inclusion Criteria:

- medial UKA implanted between 2009 and 2015 at the CCEG

Exclusion Criteria:

  • no other UKA
  • lost to follow up
  • patient refuses

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Limit indications
Obèse (BMI>30), ACL déficiency, HKA > 10°, flessum >10° [HKA : hop knee angle]
Procedure: Unicompartmental knee arthroplasty
medial unicompartmental knee arthroplasty
Historical indications
Patient with a BMI between 18,5 and 30, HKA <10°, functionnal ACL, no flessum or <5°
Procedure: Unicompartmental knee arthroplasty
medial unicompartmental knee arthroplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival of medial UKA
Time Frame: 7 years
UKA changed or replaced by TKA
7 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
to compare UKA survival if multiple limit indication
Time Frame: 7 years
UKA changed or replaced by TKA
7 years
to identify prognostic factors of re operation of patients with a medial UKA implanted between 2009 and 2015 at the CCEG
Time Frame: 7 years
ACL, flessum, HKA, weight
7 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Investigators

  • Study Director: Andre Fernandez, Central Hospital, Nancy, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2023

Primary Completion (Anticipated)

March 1, 2023

Study Completion (Anticipated)

March 1, 2023

Study Registration Dates

First Submitted

February 8, 2023

First Submitted That Met QC Criteria

February 18, 2023

First Posted (Actual)

March 1, 2023

Study Record Updates

Last Update Posted (Actual)

March 2, 2023

Last Update Submitted That Met QC Criteria

March 1, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 2022PI091

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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