Clinical Trial: Femoroacetabular Impingement (FAI): The Effectiveness of Physical Therapy

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational

Official Title: Effectiveness of Physical Therapy (PT) Alone vs PT Followed by Surgery to Alleviate the Symptoms of Femoroacetabular Impingement (FAI)

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.

Detailed 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.

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.


Sponsor: University of Colorado, Denver

Current Primary Outcome: 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.


Original Primary Outcome: Walking pain change from baseline at 26 weeks (WOMAC A1). [ Time Frame: Baseline, 2 weeks through 26 weeks ]

The primary endpoint analysis will be based upon a longitudinal model of all primary endpoint (WOMAC A1 change from baseline) data from 2 weeks through 26 weeks; the adjusted means at 26 weeks from this longitudinal model will be compared.


Current Secondary Outcome:

Original Secondary Outcome: Walking pain change from baseline at the 2, 4, 8, 16 and 26 week time points [ Time Frame: Baseline 2, 4, 8, 16 and 26 weeks ]

The primary endpoint will be assessed after 74 MONOVISC and 37 Saline Subjects have completed their 26 week visit as measured by WOMAC A1 score..


Information By: University of Colorado, Denver

Dates:
Date Received: March 6, 2017
Date Started: February 1, 2016
Date Completion: February 2019
Last Updated: March 24, 2017
Last Verified: March 2017