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NCT05749965 Clinical Trial

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

Knee Disease Clinical Trial

— PUCIL  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05749965
Other study ID # 2022PI091
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date March 2023
Est. completion date March 2023

Study information
Verified date March 2023
Source Central Hospital, Nancy, France
Contact Grégoire Vaz
Phone 0649852557
Email gregoire.vaz@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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)

Description:

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

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 522
Est. completion date March 2023
Est. primary completion date March 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - medial UKA implanted between 2009 and 2015 at the CCEG Exclusion Criteria: - no other UKA - lost to follow up - patient refuses

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Unicompartmental knee arthroplasty
medial unicompartmental knee arthroplasty

Locations
Country Name City State
France Centre Chirurgical Emile Gallé Nancy

Sponsors (1)
Lead Sponsor Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

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