Clinical trial NCT03077022: Femoroacetabular Impingement (FAI): The Effectiveness of Physical Therapy
Official title: Effectiveness of Physical Therapy (PT) Alone vs PT Followed by Surgery to Alleviate the Symptoms of Femoroacetabular Impingement (FAI)
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Femoroacetabular Impingement
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Stryker Orthopaedics
First posted: 2017-03-10
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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 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.

Eligibility 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.

Primary outcomes:
measure: Change in sub spine impingement associated with physical therapy
timeFrame: Baseline, 6 weeks, 12 weeks, 3 months, 6 months, 1 year, and 2 years.
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado School of Medicine
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: James Genuario, MD
role: PRINCIPAL_INVESTIGATOR
References: