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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04638140
Recruitment Status : Active, not recruiting
First Posted : November 20, 2020
Last Update Posted : November 20, 2020
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

Study Description
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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.

Condition or disease
Hip Arthrosis Hip Injuries

Study Design
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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Retrospective Assessment of the Morphology of Acetabular Defects: A 3D Reconstruction Approach
Actual Study Start Date : August 31, 2018
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

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Groups and Cohorts
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Group/Cohort
Healthy hip population
Hip defect population


Outcome Measures
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Primary Outcome Measures :
  1. 3D morphology [ Time Frame: 2 years ]
    Compare the 3D morphology of acetabular defects (missing bone) with traditional 2D classifications using CT images of patients with various degrees of bone defects.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-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.

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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04638140


Locations
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Belgium
University Hospitals of Leuven
Pellenberg, Vlaams-Brabant, Belgium
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
More Information
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Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT04638140    
Other Study ID Numbers: S61746
First Posted: November 20, 2020    Key Record Dates
Last Update Posted: November 20, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Universitaire Ziekenhuizen Leuven:
Hip revision surgery
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Hip
Hip Injuries
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Wounds and Injuries