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Femoroacetabular Impingement (FAI): The Effectiveness of Physical Therapy

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ClinicalTrials.gov Identifier: NCT03077022
Recruitment Status : Withdrawn
First Posted : March 10, 2017
Last Update Posted : July 2, 2019
Sponsor:
Collaborator:
Stryker Orthopaedics
Information provided by (Responsible Party):
University of Colorado, Denver

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.

Condition or disease
Femoroacetabular Impingement

Detailed Description:

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.

A paucity of evidence exists in regards to the non-operative treatment of FAI.

Several insurance companies are now requiring three to six months of physical therapy prior to approval for surgery. There is not a single study that has objectively evaluated the effectiveness of physical therapy in the avoidance of surgical intervention. The investigators plan to evaluate this using an electronic outcomes data collection system. The hypothesis is that the majority of patients will not see a significant enough improvement with physical therapy to avoid surgery, especially in a subset of patients such as those with sub spine impingement. The investigators plan to prospectively collect data for three years and monitor the outcome of each hip patient, especially those treated with physical therapy as an initial treatment and there potential avoidance of surgery.


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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effectiveness of Physical Therapy (PT) Alone vs PT Followed by Surgery to Alleviate the Symptoms of Femoroacetabular Impingement (FAI)
Study Start Date : February 2016
Actual Primary Completion Date : February 2018
Actual Study Completion Date : February 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Group/Cohort
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.



Primary Outcome Measures :
  1. Change in sub spine impingement associated with physical therapy [ Time Frame: Baseline, 6 weeks, 12 weeks, 3 months, 6 months, 1 year, and 2 years. ]
    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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03077022


Locations
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United States, Colorado
University of Colorado School of Medicine
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Stryker Orthopaedics
Investigators
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Principal Investigator: James Genuario, MD University of Colorado, Denver

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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT03077022     History of Changes
Other Study ID Numbers: 17-0244
First Posted: March 10, 2017    Key Record Dates
Last Update Posted: July 2, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Femoracetabular Impingement
Joint Diseases
Musculoskeletal Diseases
Pathologic Processes