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Stress Analysis of Hip Dysplasia

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
University of Utah
ClinicalTrials.gov Identifier:
NCT01575977
First received: March 6, 2012
Last updated: May 24, 2013
Last verified: May 2013
History of Changes
  Purpose

The main objective of this study is to predict cartilage contact pressures in the hip joint during simulated daily activities before and after periacetabular osteotomy (PAO) for correction of traditional dysplasia/retroversion using subject-specific finite element models. The effects of PAO on hip joint mechanics will be analyzed by comparing previously modeled pre-op scans (University of Utah IRB "Comparative Stress Analysis of Hip Dysplasia" #10983) to post-op model predictions in each loading scenario. The investigators study will consist of two key components: 1) CT acquisition- CT arthrogram to obtain post-operative data for generating subject-specific FE models after surgical treatment 2) Gait analysis- motion analysis to obtain subject-specific kinematics and kinetics to drive the FE model simulations post-operatively.


Condition
Hip Dysplasia

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Stress Analysis of Hip Dysplasia After Corrective Surgery

Further study details as provided by University of Utah:

Primary Outcome Measures:
  • To predict cartilage contact pressures in the hip joint during simulated daily activities before and after periacetabular osteotomy (PAO) for correction of traditional dysplasia/retroversion using subject-specific finite element models. [ Time Frame: 1 year post surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: February 2011
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

18-40 years old

Criteria

Inclusion Criteria:

  • Patients aged 18-40 years
  • Patients who have undergone periacetabular osteotomy by Dr. Peters for treatment of hip dysplasia.
  • Patients who have previously participated in IRB #10983 "Comparative Stress Analysis of Hip Dysplasia".

Exclusion Criteria:

  • Persons with a history of allergies to lidocaine or seafood.
  • Children under the age of 18.
  • Persons incarcerated, on trial, or parole.
  • Women who are pregnant.
  • Subjects who do not have high quality pre-operative images available or have not been surgically treated by periacetabular osteotomy.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01575977

Sponsors and Collaborators
University of Utah
Investigators
Principal Investigator: Andrew Anderson Orthopedic Surgery Operations
  More Information

No publications provided

Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT01575977     History of Changes
Other Study ID Numbers: 43600
Study First Received: March 6, 2012
Last Updated: May 24, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hyperplasia
Pathologic Processes

ClinicalTrials.gov processed this record on June 17, 2013