Psychological Distress and Outcomes in Hip Preservation Patients

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Stephen Aoki, University of Utah
ClinicalTrials.gov Identifier:
NCT01550263
First received: February 8, 2012
Last updated: January 7, 2014
Last verified: January 2014

February 8, 2012
January 7, 2014
January 2012
January 2018   (final data collection date for primary outcome measure)
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).
Not Provided
Complete list of historical versions of study NCT01550263 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Psychological Distress and Outcomes in Hip Preservation Patients
Pre-Operative Psychological Distress and Post-Operative Outcomes in Hip Preservation Patients

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

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Patients are selected by Dr. Aoki

Psychological Distress
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
200
January 2018
January 2018   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01550263
48948
No
Stephen Aoki, University of Utah
University of Utah
Not Provided
Principal Investigator: Stephen K Aoki, MD Orthopaedic Center
University of Utah
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP