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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04638140
Other study ID # S61746
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date August 31, 2018
Est. completion date December 2021

Study information

Verified date November 2020
Source Universitaire Ziekenhuizen Leuven
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

In this study, we aim to develop a statistical shape model and use it to reconstruct the shape of acetabula with severe defects (Paprosky 3a-3b). This will allow us to visualise and assess the morphology of the missing bone. In future studies we will use the obtained results to improve the design of acetabular implants for revision surgery.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 200
Est. completion date December 2021
Est. primary completion date December 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Trainings dataset for statistical shape model: - Patients where a bilateral CT of the hip was performed with unilateral pathologies. - We aim to include an equal amount of scans from each gender and varying ages. Dataset of defect acetabula used for reconstruction: - Patients who received a CT scan of the hip after removal of a primary/revision implant (e.g. patients where debridement was performed due to infection.) - Patients where the defect can be classified as a Paprosky 3a or 3b defect.

Study Design


Locations

Country Name City State
Belgium University Hospitals of Leuven Pellenberg Vlaams-Brabant

Sponsors (1)

Lead Sponsor Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary 3D morphology Compare the 3D morphology of acetabular defects (missing bone) with traditional 2D classifications using CT images of patients with various degrees of bone defects. 2 years
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