NCT04638140

Brief 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.

Trial Health

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Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 31, 2018

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

November 16, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 20, 2020

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 11, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 11, 2023

Completed
Last Updated

July 3, 2024

Status Verified

July 1, 2024

Enrollment Period

4.7 years

First QC Date

November 16, 2020

Last Update Submit

July 2, 2024

Conditions

Keywords

Hip revision surgery

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Healthy hip population

Hip defect population

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Trainings dataset for statistical shape model: * Bones with irregularities, such as fractures or osteophytes * Patients who received radiation therapy in the past. * Patients with bone related diseases Dataset of defect acetabula used for reconstruction: • Patients who received radiation therapy in the past.

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

University Hospitals of Leuven

Pellenberg, Vlaams-Brabant, Belgium

Location

MeSH Terms

Conditions

Osteoarthritis, HipHip Injuries

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesWounds and Injuries

Study Design

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

Study Record Dates

First Submitted

November 16, 2020

First Posted

November 20, 2020

Study Start

August 31, 2018

Primary Completion

May 11, 2023

Study Completion

May 11, 2023

Last Updated

July 3, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations