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Psychological Distress and Outcomes in Hip Preservation Patients (Hip)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01550263
First Posted: March 9, 2012
Last Update Posted: October 5, 2017
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.
Information provided by (Responsible Party):
Stephen Aoki, University of Utah
  Purpose
This is an investigatory study to determine whether high levels of pre-operative psychological distress predict worse outcomes after hip preservation. This is a low risk study and does not alter the treatment or course of care for patients undergoing this procedure

Condition
Psychological Distress

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pre-Operative Psychological Distress and Post-Operative Outcomes in Hip Preservation Patients

Further study details as provided by Stephen Aoki, University of Utah:

Primary Outcome Measures:
  • Distress and Risk Assessment Method (DRAM) questionaire [ Time Frame: 1 year ]
    Distress and Risk Assessment Method (DRAM) questionaire to screen for psychological distress. The instrument defines four categories based on patients responses: Type N (normal; lower scores, no evidence of distress); Type R (at risk; higher scores, primarily in symptoms of depression); Type DD (distressed-depressive; higher scores on all variables, but very high on depressive symptomatology); and Type DS (distressed-somatic; higher scores on all variables, but very high on somatic awareness).


Estimated Enrollment: 200
Study Start Date: January 2012
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: January 2019 (Final data collection date for primary outcome measure)
Detailed Description:
The correlation between increasing psychological distress and worsening surgical outcomes has been extensively documented in patients undergoing spine surgery. However, we have no reason to believe that patients with hip pathology are uniquely exempt from the influence of psychosocial factors. To our knowledge, no study has been done to evaluate the effect of pre-operative psychological distress on outcomes after hip preservation surgery. We therefore propose to use the DRAM to measure pre-operative distress in patients undergoing open or arthroscopic hip preservation surgery and to compare these pre-operative distress scores with post-operative outcomes. We hope the information we gain will allow clinicians to comprehensively evaluate the patient with hip pain and to make more informed choices about operative treatment.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients are selected by Dr. Aoki
Criteria

Inclusion Criteria:

  1. Primary presenting complaint of hip pain
  2. Hip arthroscopy, surgical dislocation and debridement, and/or periacetabular osteotomy performed by Dr. Aoki or Dr. Peters for hip pathology diagnosed by history, clinical examination and/or imaging

Exclusion Criteria:

  1. Unable to complete the DRAM questionnaire
  2. Patients who do not undergo surgery
  Contacts and Locations
Information from the National Library of Medicine

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): NCT01550263


Locations
United States, Utah
Orthopaedic Center
Salt Lake City, Utah, United States, 84108
Sponsors and Collaborators
University of Utah
Investigators
Principal Investigator: Stephen K Aoki, MD Orthopaedic Center
  More Information

Responsible Party: Stephen Aoki, M.D., University of Utah
ClinicalTrials.gov Identifier: NCT01550263     History of Changes
Other Study ID Numbers: 48948
First Submitted: February 8, 2012
First Posted: March 9, 2012
Last Update Posted: October 5, 2017
Last Verified: October 2017

Keywords provided by Stephen Aoki, University of Utah:
Hip Preservation
Hip Arthroscopy
Hip Pain
Psychological distress