NCT05749965

Brief Summary

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)

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
522

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2023

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

February 8, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 1, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

March 2, 2023

Status Verified

March 1, 2023

Enrollment Period

Same day

First QC Date

February 8, 2023

Last Update Submit

March 1, 2023

Conditions

Knee Disease

Outcome Measures

Primary Outcomes (1)

  • Survival of medial UKA

    UKA changed or replaced by TKA

    7 years

Secondary Outcomes (2)

  • to compare UKA survival if multiple limit indication

    7 years

  • to identify prognostic factors of re operation of patients with a medial UKA implanted between 2009 and 2015 at the CCEG

    7 years

Study Arms (2)

Limit indications

Obèse (BMI\>30), ACL déficiency, HKA \> 10°, flessum \>10° \[HKA : hop knee angle\]

Procedure: 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

Interventions

Unicompartmental knee arthroplastyPROCEDURE

medial unicompartmental knee arthroplasty

Historical indicationsLimit indications

Eligibility Criteria

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

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

You may qualify if:

  • \- medial UKA implanted between 2009 and 2015 at the CCEG

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Chirurgical Emile Gallé

Nancy, 54000, France

Location

MeSH Terms

Interventions

Arthroplasty, Replacement, Knee

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Officials

  • Andre Fernandez

    Central Hospital, Nancy, France

    STUDY DIRECTOR

Central Study Contacts

Grégoire Vaz

CONTACT

0649852557gregoire.vaz@gmail.com

Andrea Fernandez, Dr

CONTACT

650506979a.fernandez@chru-nancy.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 8, 2023

First Posted

March 1, 2023

Study Start

March 1, 2023

Primary Completion

March 1, 2023

Study Completion

March 1, 2023

Last Updated

March 2, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)