Retrospective Assessment of the Morphology of Acetabular... | NCT04638140

Studies
Retrospective Assessment of the Morphology of Acetabular Defects: A 3D Reconstruction Approach

NCT04638140

Sponsor

Universitaire Ziekenhuizen KU Leuven

Status

Terminated

Last Update Posted

Jul 3, 2024Actual

Enrollment

200Actual

Phase

Not provided

Conditions

Hip Arthrosis
Hip Injuries

Interventions

Not provided

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2024

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Inactive

Expanded Access Info

Start Date

Aug 31, 2018Actual

Primary Completion Date

May 11, 2023Actual

Completion Date

May 11, 2023Actual

First Submitted Date

Nov 16, 2020

First Submission Date that Met QC Criteria

Nov 16, 2020

First Posted Date

Nov 20, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 2, 2024

Last Update Posted Date

Jul 3, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospitals of Leuven		Pellenberg	Vlaams-Brabant		Belgium

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015207	Osteoarthritis, Hip
D025981	Hip Injuries

Ancestor Terms

ID	Term
D010003	Osteoarthritis
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Label	Type	Description	Intervention Names
Healthy hip population
Hip defect population