Psychological Distress and Outcomes in Hip Preservation Patients
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Stephen Aoki, University of Utah
First received: February 8, 2012
Last updated: July 16, 2015
Last verified: July 2015
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
||Observational Model: Cohort
Time Perspective: Prospective
||Pre-Operative Psychological Distress and Post-Operative Outcomes in Hip Preservation Patients
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:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||January 2018 (Final data collection date for primary outcome measure)
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.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Patients are selected by Dr. Aoki
- Primary presenting complaint of hip pain
- 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
- Unable to complete the DRAM questionnaire
- Patients who do not undergo surgery
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
|Salt Lake, Utah, United States, 84108 |
University of Utah
||Stephen K Aoki, MD
No publications provided
||Stephen Aoki, M.D., University of Utah
History of Changes
|Other Study ID Numbers:
|Study First Received:
||February 8, 2012
||July 16, 2015
||United States: Institutional Review Board
Keywords provided by University of Utah:
ClinicalTrials.gov processed this record on August 27, 2015