NCT01550263

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
217

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 8, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 9, 2012

Completed
10.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
Last Updated

February 8, 2023

Status Verified

February 1, 2023

Enrollment Period

10.8 years

First QC Date

February 8, 2012

Last Update Submit

February 6, 2023

Conditions

Psychological Distress

Keywords

Hip PreservationHip ArthroscopyHip PainPsychological distress

Outcome Measures

Primary Outcomes (1)

  • Distress and Risk Assessment Method (DRAM) questionaire

    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).

    1 year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients are selected by Dr. Aoki

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Orthopaedic Center

Salt Lake City, Utah, 84108, United States

Location

Study Officials

  • Stephen K Aoki, MD

    Orthopaedic Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

February 8, 2012

First Posted

March 9, 2012

Study Start

January 1, 2012

Primary Completion

November 1, 2022

Study Completion

November 1, 2022

Last Updated

February 8, 2023

Record last verified: 2023-02

Locations

US(1)