NCT05510011

Brief Summary

A new surgical technique of reconstruction for bone loss in TKA revision using tantalum cone and allograft. Study of radiological and clinical outcomes.

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
76

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2022

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

Study Start

First participant enrolled

January 1, 2022

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

January 25, 2022

Completed
7 months until next milestone

First Posted

Study publicly available on registry

August 22, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2023

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 21, 2023

Completed
Last Updated

August 22, 2022

Status Verified

January 1, 2022

Enrollment Period

1.1 years

First QC Date

January 25, 2022

Last Update Submit

August 16, 2022

Conditions

TantalumBone LossAllograft

Keywords

TantalumAllograftTKA revision using tantalum cone and/or allograft

Outcome Measures

Primary Outcomes (1)

  • Rate of Survivorship of the implant

    Survivorship of the implant

    day 1

Eligibility Criteria

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

Pregnant women attending for 3rd timester scan

You may qualify if:

  • \> 18 years old
  • TKA revision using tantalum cone or allograft

You may not qualify if:

  • \<18 years old
  • no reconstruction used in TKA revision

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

RECRUITING

MeSH Terms

Conditions

Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Louis DAGNEAUX, PHU

    University Hospital, Montpellier

    STUDY DIRECTOR

Central Study Contacts

Louis DAGNEAUX, PHU

CONTACT

04 67 33 09 80f-fuchs@chu-montpellier.fr

Elias BOUGAUD, Resident

CONTACT

682500767e-bougaud@chu-montpellier.fr

Study Design

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

Study Record Dates

First Submitted

January 25, 2022

First Posted

August 22, 2022

Study Start

January 1, 2022

Primary Completion

February 20, 2023

Study Completion

February 21, 2023

Last Updated

August 22, 2022

Record last verified: 2022-01

Locations

FR(1)