Psychological Distress and Outcomes in Hip Preservation Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Stephen Aoki, University of Utah
ClinicalTrials.gov Identifier:
NCT01550263
First received: February 8, 2012
Last updated: July 11, 2014
Last verified: July 2014
  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 University of Utah:

Primary Outcome Measures:
  • Distress and Risk Assessment Method (DRAM) questionaire [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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 2018
Estimated Primary Completion Date: January 2018 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01550263

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

No publications provided

Responsible Party: Stephen Aoki, M.D., University of Utah
ClinicalTrials.gov Identifier: NCT01550263     History of Changes
Other Study ID Numbers: 48948
Study First Received: February 8, 2012
Last Updated: July 11, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 28, 2014