Outcome in Hip Preservation Patients
| Tracking Information | |||||
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| First Received Date ICMJE | February 8, 2012 | ||||
| Last Updated Date | March 6, 2012 | ||||
| Start Date ICMJE | January 2012 | ||||
| Estimated Primary Completion Date | January 2018 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT01550263 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Outcome in Hip Preservation Patients | ||||
| Official Title ICMJE | Pre-Operative Psychological Distress and Post-Operative Outcomes in Hip Preservation Patients | ||||
| Brief Summary | 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 |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | Patients are selected by Dr. Aoki |
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| Condition ICMJE | Hip Pain | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Enrolling by invitation | ||||
| Estimated Enrollment ICMJE | 200 | ||||
| Estimated Completion Date | January 2018 | ||||
| Estimated Primary Completion Date | January 2018 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01550263 | ||||
| Other Study ID Numbers ICMJE | 48948 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | University of Utah | ||||
| Study Sponsor ICMJE | University of Utah | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University of Utah | ||||
| Verification Date | March 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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