NCT03077022

Brief Summary

The treatment of femoroacetabular impingement has evolved over the last several years. As the number of arthroscopic hip operations has risen over the last few years, so has the level controversy in regards to the appropriate initial management. There have been many recent advances in clinical diagnosis, advanced imaging techniques, improved indications for surgery and improved arthroscopic techniques which have led to improved clinical outcomes, but the effectiveness of physical therapy remains unknown.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2016

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 6, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 10, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

July 2, 2019

Status Verified

June 1, 2019

Enrollment Period

2 years

First QC Date

March 6, 2017

Last Update Submit

June 28, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in sub spine impingement associated with physical therapy

    The investigators plan to prospectively collect data and monitor the outcome of each hip patient. Subjects will complete a number of assessments utilizing iPads with an electronic data collection system. The data will be collected during each visit or done remotely via the internet, at which time the adjusted means from this longitudinal model will be compared.

    Baseline, 6 weeks, 12 weeks, 3 months, 6 months, 1 year, and 2 years.

Study Arms (1)

Femoracetabular impingent (FAI)

Subjects will be given a prescription for physical therapy specifically for Femoracetabular impingent (FAI). They will then be followed clinically per the investigator's normal routine and the gold standard.

Eligibility Criteria

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

Subjects will be included if they are 18-65 years old. Patients with hip pain are routinely seen in our clinic. Patients who meet the inclusion/exclusion criteria will be offered the opportunity to participate in the study.

You may qualify if:

  • symptoms consistent with femoroacetabular impingement (FAI)
  • a physical exam consistent with FAI
  • radiographic measurements consistent with the diagnosis including an anterior pincer lesion and/or a alpha angle greater than 55 degrees

You may not qualify if:

  • subjects do not have FAI by physical exam and radiographic parameters
  • joint space \<2mm
  • have had prior physical therapy for FAI
  • have had prior hip surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado School of Medicine

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Femoracetabular Impingement

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • James Genuario, MD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR
0

Study Design

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

Study Record Dates

First Submitted

March 6, 2017

First Posted

March 10, 2017

Study Start

February 1, 2016

Primary Completion

February 1, 2018

Study Completion

February 1, 2018

Last Updated

July 2, 2019

Record last verified: 2019-06

Locations