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Stress Analysis of Hip Dysplasia

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: NCT01575977
Recruitment Status : Completed
First Posted : April 12, 2012
Last Update Posted : November 4, 2019
Sponsor:
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
Change History
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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
Removed Location Countries  
 
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