NCT06559592

Brief Summary

This retrospective, monocentric study is about outcomes concerning patients who benefit from medial unicompartmental knee arthroplasty after previous high tibial osteotomy. This previous high tibial osteotomy was performed because of genu varum. Clinical, funtionnal and radiological outcomes were examined.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

August 5, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 29, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 2, 2021

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 4, 2022

Completed
2 years until next milestone

First Posted

Study publicly available on registry

August 19, 2024

Completed
Last Updated

August 19, 2024

Status Verified

May 1, 2022

Enrollment Period

2 months

First QC Date

August 4, 2022

Last Update Submit

August 14, 2024

Conditions

Keywords

orthopedic surgeryunicompartmental knee arthroplastyhigh tibial osteotomy

Outcome Measures

Primary Outcomes (1)

  • Give the functional results using the Oxford score, for patients who underwent this procedure.

    Oxford Knee Scale (OKS) score results after a mean follow-up of 79 months after unicompartmental internal arthroplasty, and a mean follow-up of 185 months after tibial valgization osteotomy

    from 4 to 185 months

Eligibility Criteria

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

patients aged of at least18 years old, who benefit from medial unicompartmental knee arthroplasty after previous high tibial osteotomy. The high tibial osteotomy was made because of genu varum.

You may qualify if:

  • operated between January 2005 and June 2019
  • HTO followed by implantation of medial UKA (Oxford Partial Knee, Zimmer Biomet, Bridgend, UK) in the same knee
  • medial knee osteoarthritis with healthy lateral compartment
  • patellofemoral pain
  • coronal plane deformity of less than 15°

You may not qualify if:

  • death
  • lost to follow-up
  • medial UKA implant other than the Oxford Partial Knee

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Brest

Brest, 29609, France

Location

Study Design

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

Study Record Dates

First Submitted

August 4, 2022

First Posted

August 19, 2024

Study Start

August 5, 2021

Primary Completion

September 29, 2021

Study Completion

November 2, 2021

Last Updated

August 19, 2024

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will share

All collected data that underlie results in a publication

Shared Documents
STUDY PROTOCOL
Time Frame
Data will be available after the publication of result and ending five years maximum following the last visit of the last patient
Access Criteria
Data access requests will be reviewed by the internal committee of Brest UH. requestors will be required to sign and complete a data access agreement

Locations