Stress Analysis of Hip Dysplasia

• ClinicalTrials.gov Identifier: NCT01575977
• Recruitment Status: Completed
• First Posted: April 12, 2012
• Last Update Posted: November 4, 2019
• Sponsor: University of Utah
• Information provided by (Responsible Party): Andrew Anderson, University of Utah

Tracking Information

• First Submitted Date: March 6, 2012
• First Posted Date: April 12, 2012
• Last Update Posted Date: November 4, 2019
• Study Start Date: February 2011
• Actual Primary Completion Date: August 2019 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: February 10, 2014): 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. [ Time Frame: 1 year post surgery ]
• Original Primary Outcome Measures: Not Provided
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Stress Analysis of Hip Dysplasia
• Official Title: Stress Analysis of Hip Dysplasia After Corrective Surgery
• Brief Summary: The main objective of this study is to predict cartilage contact pressures in the hip after periacetabular osteotomy (PAO).
• Detailed Description: PAO was designed as a joint preserving surgical procedure to compensate for a shallow acetabulum by re-orienting the acetabulum into a position that provides better coverage of the femoral head. Although the overall theory that increasing load bearing area (improving coverage of the femoral head) results in reduced joint stress is intuitive, the complex bony surface may not behave in this manner. It is possible that joint stress may increase when the acetabulum is reoriented into a position that increases load bearing area if post-operative joint congruency is worse than pre-operative.
• Study Type: Observational
• Study Design: Observational Model: Other; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: 18-40 years old
• Condition: Hip Dysplasia
• Intervention: Not Provided
• Study Groups/Cohorts: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 31, 2019): 12
• Original Estimated Enrollment (submitted: April 11, 2012): 24
• Actual Study Completion Date: August 2019
• Actual Primary Completion Date: August 2019 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 40 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT01575977
• Other Study ID Numbers: 43600
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Andrew Anderson, University of Utah
• Study Sponsor: University of Utah
• Collaborators: Not Provided

Investigators

• Principal Investigator: Andrew Anderson; Orthopedic Surgery Operations

• PRS Account: University of Utah
• Verification Date: October 2019