Femoroacetabular Impingement (FAI): The Effectiveness of Physical Therapy

Femoroacetabular Impingement Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03077022
• Other study ID #: 17-0244
• Status: Withdrawn
• Start date: February 2016
• Est. completion date: February 2018

Study information

• Verified date: June 2019
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Femoracetabular Impingement
• Femoroacetabular Impingement

Locations

Country	Name	City	State
United States	University of Colorado School of Medicine	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	Stryker Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.