Clinical trial NCT01993615: A Physical Therapy Program Versus Surgery for Femoroacetabular Impingement: Randomized Clinical Trial
Official title: A Supervised Physical Therapy Program vs. Arthroscopic Surgery for Femoroacetabular Impingement: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Femoroacetabular Impingement
Keywords: FAI
femoroacetabular impingement
hip pain
hip arthroscopy
physical therapy
Lead sponsor: Madigan Army Medical Center
Sponsor class: FED
First posted: 2013-11-25
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the outcomes for patients that receive two different treatments used for FAI (Femoroacetabular Impingement). The programs are 1) a 6-week supervised physical therapy program and 2) arthroscopic surgery. Enrollment is limited to patients that have already been determined surgical candidates. The study is following patients for a 2-year period.

Detailed description: This study plans to enroll a total of 60 Tricare beneficiaries primarily from the Madigan Healthcare System with a diagnosis of FAI that are surgical candidates and have already failed at least six weeks of conservative treatment.

This is a randomized controlled study comparing outcomes for the standard treatment for FAI and/or acetabular labral pathology (arthroscopy with or without labral repair) versus physical therapy. For subjects in the arthroscopy group, the surgery will be performed by the Orthopedic Surgical Service at Madigan Army Medical Center.

Subjects randomized to the physical therapy group will follow a treatment plan implemented by a physical therapist within the Madigan Army Healthcare System.

After consent, subjects will be randomized into one of two arms (Group I = hip arthroscopy, Group II = physical therapy). Group I will undergo hip arthroscopy with or without labral repair. Group II will follow a FAI-based physical therapy program x 12 sessions (6 weeks).

The arthroscopy group will complete outcome measures at time of consent and following surgery at 6 months, 1 year and 2 year time periods. Subjects in this group will follow a standardized post-operative rehabilitation protocol.

The physical therapy group will complete outcomes measures at time of consent and at 6 month, 1 year and 2 year time periods following the initial physical therapy evaluation. Subjects in this group will complete 6 weeks of an impairment-based physical therapy program.

In addition to the outcome measures taken, healthcare utilization and associated costs for hip-related care during this 2-year period will also calculated for comparison between the 2 groups.

Eligibility criteria: Inclusion Criteria:

* Tricare beneficiaries between the ages of 18 and 65
* Diagnosis of FAI and/or labral pathology confirmed by a combination of the following:

  * Pain at the anterior hip or groin
  * Pain with hip flexion
  * Positive FADIR test
  * Patient report relief of pain after intra-articular injection
* Surgical candidate for hip arthroscopy defined by (must have both):

  * No less than 2 mm of joint space based on imaging (CT scan, radiographs and MR arthrogram)
  * Positive crossover sign and/or alpha angle \>50 deg based on imaging (CT scan, radiographs and MR arthrogram)
* Failed 6 weeks of conservative management

Exclusion Criteria:

* Pregnancy
* Has other concurrent systemic disease that may affect the condition (cancer, rheumatoid arthritis, or other systemic arthralgia/arthritis)
* Has had surgery on the same hip that will be analyzed in the study
* Diagnosis of hip osteoarthritis is more likely
* Clearing the lumbar spine reproduces the patient's hip symptoms
* Plans to move/relocate out of the local area within 6 months
* Pending litigation for their hip condition
* Unable to give informed consent to participate in the study
* Unable to speak or read or write in English (due to inability to fill out outcome measures)

Primary outcomes:
measure: Hip Outcome Score - ADL Subscale at 24 Months
timeFrame: 24 months
measure: Hip Outcome Score - Sport Subscale at 24 Months
timeFrame: 24 months
Secondary outcomes:
measure: Group Differences in International Hip Outcome Score (IHOT33) to 24 Months
timeFrame: 24 months
measure: Global Rating of Change Score of 3+ or Higher (Minimum Clinically Important Change)
timeFrame: 24 months
Other outcomes:
measure: Self-Motivation Inventory
timeFrame: Baseline
measure: Changes From Baseline Pain Catastrophizing Scale at 24 Months
timeFrame: 24 months
Locations:
city: Tacoma
country: United States
facility: Madigan Army Medical Center
state: Washington
Study officials:
affiliation: Madigan Army Medical Center
name: Nancy Mansell, PT, DPT
role: PRINCIPAL_INVESTIGATOR
affiliation: Madigan Army Medical Center
name: Daniel Rhon, DPT, DSc
role: STUDY_CHAIR
References:
citation: Mansell NS, Rhon DI, Meyer J, Slevin JM, Marchant BG. Arthroscopic Surgery or Physical Therapy for Patients With Femoroacetabular Impingement Syndrome: A Randomized Controlled Trial With 2-Year Follow-up. Am J Sports Med. 2018 May;46(6):1306-1314. doi: 10.1177/0363546517751912. Epub 2018 Feb 14.
citation: Mansell NS, Rhon DI, Marchant BG, Slevin JM, Meyer JL. Two-year outcomes after arthroscopic surgery compared to physical therapy for femoracetabular impingement: A protocol for a randomized clinical trial. BMC Musculoskelet Disord. 2016 Feb 4;17:60. doi: 10.1186/s12891-016-0914-1.