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Completed

NCT Number: NCT01550263

Psychological Distress and 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

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Key information

Conditions

Psychological Distress

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Orthopaedic Center

Salt Lake City, Utah, 84108, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Unable to complete the DRAM questionnaire
  • Patients who do not undergo surgery

Treatment and study plan

Primary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Official study title

Pre-Operative Psychological Distress and Post-Operative Outcomes in Hip Preservation Patients

Acronym: Hip

Important dates

Study start
2012
Primary completion
2022
Study completion
2022
First posted
Mar 9, 2012
Registry last updated
Feb 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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