NCT01396694

Brief Summary

All patients undergoing arthroscopy or arthroplasty for temporomandibular joint dysfunction will complete a psychological questionnaire prior to surgery. The 3 month outcomes including pain and function will be examined using regression analysis to identify psychological variables that may predict outcomes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
105

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2009

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

June 1, 2009

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

July 8, 2011

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 19, 2011

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

February 17, 2016

Status Verified

February 1, 2016

Enrollment Period

3.5 years

First QC Date

July 8, 2011

Last Update Submit

February 16, 2016

Conditions

Psychological Predictors

Outcome Measures

Primary Outcomes (1)

  • Pain

    Pain will be recorded in a site specific matter (left and right TMJ) using a visual analogue scale

    3 months

Secondary Outcomes (1)

  • Function

    3 months

Study Arms (1)

all

All patients requiring arthroscopy or arthroplasty

Other: Questionnaire

Interventions

QuestionnaireOTHER

Questionnaire

all

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

18 yrs

You may qualify if:

  • require arthroscopy or arthroplasty

You may not qualify if:

  • age less than 18 yrs
  • prior surgery
  • unable to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emory University

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

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

Study Record Dates

First Submitted

July 8, 2011

First Posted

July 19, 2011

Study Start

June 1, 2009

Primary Completion

December 1, 2012

Study Completion

December 1, 2015

Last Updated

February 17, 2016

Record last verified: 2016-02

Locations

US(1)