NCT01390103

Brief Summary

The purpose of this project is to determine the effect of hip injections on hip biomechanics in patients with hip pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
29

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2011

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

March 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 5, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 8, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

April 22, 2013

Status Verified

April 1, 2013

Enrollment Period

1.6 years

First QC Date

July 5, 2011

Last Update Submit

April 18, 2013

Conditions

Keywords

hip pain

Outcome Measures

Primary Outcomes (1)

  • Determine the immediate biomechanical effect in patients that receive a hip injection.

    The biomechanical assessment of gait will consist of walking on a gait mat. The mat is a specialized pressure sensor system. Prior to data collection, each participant will walk across the mat three times for acclimation. The first assessment will include a walk at a self-selected, comfortable pace across the mat, repeated three times. The second assessment will include walking as quickly as possible, also repeated three times.

    The short-term biomechanical effects of the hip will be evaluated within 1 hour of the patient receiving the injection.

Secondary Outcomes (4)

  • Oswestry Hip Pain Disability Questionnaire

    Baseline, Within 1 hour of hip injection, 2 weeks post-injection

  • Medical Outcomes Study (MOS) Short-Form Health Survey (SF-12)

    Baseline, Within 1 hour of injection, 2 weeks post-injection

  • 10 centimeter Visual Analog Scale (VAS)

    Baseline, Within 1 hour of injection, 2 weeks post-injection

  • Pain Provocative Maneuvers

    Baseline, Within 1 hour of injection, 2 weeks pos-injection

Study Arms (1)

Assessment following the hip injection

Assessment to evaluate the effect of the hip injection on biomechanics.

Other: Assessment following hip injection

Interventions

Assessment to evaluate the effect of the hip injection on biomechanics.

Assessment following the hip injection

Eligibility Criteria

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

Potential subjects will be all patients receiving a hip injection for hip pain.

You may qualify if:

  • Osteoarthritis patients with hip pain requiring hip injection
  • Receiving hip injection
  • BMI \< 35

You may not qualify if:

  • BMI \> 35
  • severely impaired intellectual capacity
  • dementia, or other neurodegenerative diseases that would preclude appropriate cognitive or physical ability to perform study protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UF&Shands Orthopaedics and Sports Medicine Institute

Gainesville, Florida, 32607, United States

Location

Study Officials

  • MaryBeth Horodyski, PhD

    University of Florida Departmen of Orthopaedics

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2011

First Posted

July 8, 2011

Study Start

March 1, 2011

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

April 22, 2013

Record last verified: 2013-04

Locations