Femoroacetabular Impingement
Conditions
Keywords
FAI, femoroacetabular impingement, hip pain, hip arthroscopy, physical therapy
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.
Interventions
PROCEDUREArthroscopic Surgery
The hip arthroscopy will consist of acetabular rim trimming, labral repair or debridement and femoroplasty, all as indicated based on the surgeon's clinical judgment with input from pre-operative imaging, exam findings and intra-operative findings.
PROCEDUREPhysical Therapy
Subjects will participate in two 45-minute sessions for six weeks (total of 12 sessions). The physical therapy treatment plan will be based on individual impairments identified during the initial evaluation, and include manual therapy to the hip, lumbar spine, and pelvis, as well as therapeutic exercise all tailored to individual patient impairments.
Sponsors
Madigan Army Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hip Outcome Score - ADL Subscale at 24 Months | 24 months | The Hip Outcome Score is designed to assess higher-level activities (i.e. those required in athletics) and has demonstrated validity in a study of patients at a mean of three years following hip arthroscopy. Additionally, a 2011 study states that the HOS has the greatest amount of clinimetric evidence (rigor of rating scales and indexes for the description of clinical phenomena). Only three published patient-reported outcome instruments utilized to assess FAI and labral pathology use clinimetric evidence and the HOS was identified as the most proven instrument. The HOS ADL Subscale consisted of 19 questions, each scored on a 5-point scale from 0 (unable to do) to 4 (no difficulty). The final score is calculated by taking the raw score, dividing it by the number of total questions answered multipled by 4 x 100 for a final score that ranges from 0 to 100%, with lower scores associated with greater limitation in Activities of Daily Living (ADL). |
| Hip Outcome Score - Sport Subscale at 24 Months | 24 months | The Hip Outcome Score is designed to assess higher level activities (i.e. those required in athletics) and has demonstrated validity in a study of patients at a mean of three years following hip arthroscopy. Additionally, a 2011 study states that the HOS has the greatest amount of clinimetric evidence (rigor of rating scales and indexes for the description of clinical phenomena). Only three published patient-reported outcome instruments utilized to assess FAI and labral pathology use clinimetric evidence and the HOS was identified as the most proven instrument. The HOS Sport Subscale consists of 9 questions, each scored on a 5-point scale from 0 (unable to do) to 4 (no difficulty). The final score is calculated by taking the raw score, dividing it by the number of total questions answered multipled by 4 x 100 for a final score that ranges from 0 to 100%, with lower scores associated with greater limitations in Sports-related activities. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Group Differences in International Hip Outcome Score (IHOT33) to 24 Months | 24 months | The iHOT33 is a quality-of-life patient-reported outcome measure that uses a visual analog scale response format for young, active patients with hip pathology. This 33-item questionnaire includes four sections: symptoms and functional limitations, sports and recreational activities, job related concerns and social, emotional and lifestyle concerns. This outcome measure has shown to be reliable; shows face, content and contrast validity and is highly responsive to clinical change. It uses a visual analog scale with the verbal anchors no problems at all on the far right and significantly impaired on the left. The total score is calculated as a simple mean of the responses ranging from 0 to 100, with 100 representing the best possible quality-of-life score. |
| Global Rating of Change Score of 3+ or Higher (Minimum Clinically Important Change) | 24 months | The GROC will be administered to patients at the 6 months, one year and two year time points. The GROC questionnaire is a common, feasible, and useful method for assessing short term outcomes and overall changes in quality of life and is a valid measurement of change in patient status in a variety of pain populations. The GROC has a 15-point scale with a change of positive three points or higher (3+) demonstrating clinically significant improvement in a patient's perception of quality of life. Scores of -1 to -7 indicate negative perception of improvement (worsening of condition), a 0 indicates no change, and scores of +1 through +7 indicate a positive perceived improvement in the patients condition. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Self-Motivation Inventory | Baseline | The Self-Motivation Inventory is an outcome measure that was developed to determine level of motivation. The Self-Motivation Inventory is a 40-item tool that has been found to measure an individual's tendency to persevere independent of situational reinforcement. It has also been used to predict successful weight loss and may correlate with number of sessions attended in weight loss program \[29\]. This tool underwent refinement in 1980 with the original 60-item tool being tested in undergraduate male and females. Items correlating less than 0.30 were deleted. The final 40-item scale yielded an exceptionally high internal reliability (α = 0.91) suggesting that a unitary common concept is evident for the obtained factor structure. The tool is widely used and has been tested in weight loss and therapeutic exercise studies |
| Changes From Baseline Pain Catastrophizing Scale at 24 Months | 24 months | The PCS is a 13-item patient-report scale developed to measure the extent to which people catastrophize in response to pain. Each item is scored from 0 ('not at all') to 4 ('all the time'). The PCS is reported as a total score, with higher scores indicating greater catastrophizing, and is composed of three sub-scales: Rumination (four items; e.g. 'When I am in pain, I keep thinking about how badly I want the pain to stop'), Magnification (three items; e.g. 'When I am in pain, I become afraid that the pain will get worse'), and Helplessness (six items; e.g. 'When I am in pain, I feel I can't go on'). The PCS has been shown to have high levels of internal consistency and construct validity. |
Countries
United States
Participant flow
Recruitment details
Recruitment occurred from the orthopaedic clinic at Madigan Army Medical Center
Participants by arm
| Arm | Count |
|---|---|
| Arthroscopic Surgery Arthroscopic surgery at the femoroacetabular joint, followed by a standardized post-operative rehabilitation protocol in physical therapy.
Arthroscopic Surgery: The hip arthroscopy will consist of acetabular rim trimming, labral repair or debridement and femoroplasty, all as indicated based on the surgeon's clinical judgment with input from pre-operative imaging, exam findings and intra-operative findings. | 40 |
| Physical Therapy An impairment-based supervised in-clinic physical therapy program.
Physical Therapy: Subjects will participate in two 45-minute sessions for six weeks (total of 12 sessions). The physical therapy treatment plan will be based on individual impairments identified during the initial evaluation, and include manual therapy to the hip, lumbar spine, and pelvis, as well as therapeutic exercise all tailored to individual patient impairments. | 40 |
| Total | 80 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 0 |
Baseline characteristics
| Characteristic | Physical Therapy | Total | Arthroscopic Surgery |
|---|---|---|---|
| Age, Continuous | 30.6 years STANDARD_DEVIATION 7.4 | 30.1 years STANDARD_DEVIATION 7.4 | 29.7 years STANDARD_DEVIATION 7.4 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 6 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 9 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) White | 28 Participants | 58 Participants | 30 Participants |
| Sex: Female, Male Female | 14 Participants | 33 Participants | 19 Participants |
| Sex: Female, Male Male | 26 Participants | 47 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 40 | 0 / 40 |
| other Total, other adverse events | 2 / 40 | 2 / 40 |
| serious Total, serious adverse events | 0 / 40 | 0 / 40 |
Outcome results
Primary
Hip Outcome Score - ADL Subscale at 24 Months
The Hip Outcome Score is designed to assess higher-level activities (i.e. those required in athletics) and has demonstrated validity in a study of patients at a mean of three years following hip arthroscopy. Additionally, a 2011 study states that the HOS has the greatest amount of clinimetric evidence (rigor of rating scales and indexes for the description of clinical phenomena). Only three published patient-reported outcome instruments utilized to assess FAI and labral pathology use clinimetric evidence and the HOS was identified as the most proven instrument. The HOS ADL Subscale consisted of 19 questions, each scored on a 5-point scale from 0 (unable to do) to 4 (no difficulty). The final score is calculated by taking the raw score, dividing it by the number of total questions answered multipled by 4 x 100 for a final score that ranges from 0 to 100%, with lower scores associated with greater limitation in Activities of Daily Living (ADL).
Time frame: 24 months
Population: Intention to treat analysis including only participants that received any treatment (6 participants that were enrolled never returned for treatment)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Arthroscopic Surgery | Hip Outcome Score - ADL Subscale at 24 Months | 69.3 score on a scale |
| Physical Therapy | Hip Outcome Score - ADL Subscale at 24 Months | 73.1 score on a scale |
Primary
Hip Outcome Score - Sport Subscale at 24 Months
The Hip Outcome Score is designed to assess higher level activities (i.e. those required in athletics) and has demonstrated validity in a study of patients at a mean of three years following hip arthroscopy. Additionally, a 2011 study states that the HOS has the greatest amount of clinimetric evidence (rigor of rating scales and indexes for the description of clinical phenomena). Only three published patient-reported outcome instruments utilized to assess FAI and labral pathology use clinimetric evidence and the HOS was identified as the most proven instrument. The HOS Sport Subscale consists of 9 questions, each scored on a 5-point scale from 0 (unable to do) to 4 (no difficulty). The final score is calculated by taking the raw score, dividing it by the number of total questions answered multipled by 4 x 100 for a final score that ranges from 0 to 100%, with lower scores associated with greater limitations in Sports-related activities.
Time frame: 24 months
Population: Intention to treat analysis including only participants that received any treatment (6 participants that were enrolled never returned for treatment)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Arthroscopic Surgery | Hip Outcome Score - Sport Subscale at 24 Months | 55.3 score on a scale |
| Physical Therapy | Hip Outcome Score - Sport Subscale at 24 Months | 57.1 score on a scale |
Secondary
Global Rating of Change Score of 3+ or Higher (Minimum Clinically Important Change)
The GROC will be administered to patients at the 6 months, one year and two year time points. The GROC questionnaire is a common, feasible, and useful method for assessing short term outcomes and overall changes in quality of life and is a valid measurement of change in patient status in a variety of pain populations. The GROC has a 15-point scale with a change of positive three points or higher (3+) demonstrating clinically significant improvement in a patient's perception of quality of life. Scores of -1 to -7 indicate negative perception of improvement (worsening of condition), a 0 indicates no change, and scores of +1 through +7 indicate a positive perceived improvement in the patients condition.
Time frame: 24 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arthroscopic Surgery | Global Rating of Change Score of 3+ or Higher (Minimum Clinically Important Change) | 16 Participants |
| Physical Therapy | Global Rating of Change Score of 3+ or Higher (Minimum Clinically Important Change) | 15 Participants |
Secondary
Group Differences in International Hip Outcome Score (IHOT33) to 24 Months
The iHOT33 is a quality-of-life patient-reported outcome measure that uses a visual analog scale response format for young, active patients with hip pathology. This 33-item questionnaire includes four sections: symptoms and functional limitations, sports and recreational activities, job related concerns and social, emotional and lifestyle concerns. This outcome measure has shown to be reliable; shows face, content and contrast validity and is highly responsive to clinical change. It uses a visual analog scale with the verbal anchors no problems at all on the far right and significantly impaired on the left. The total score is calculated as a simple mean of the responses ranging from 0 to 100, with 100 representing the best possible quality-of-life score.
Time frame: 24 months
Population: Intention to treat analysis including only participants that received any treatment (6 participants that were enrolled never returned for treatment)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Arthroscopic Surgery | Group Differences in International Hip Outcome Score (IHOT33) to 24 Months | 51.2 score on a scale |
| Physical Therapy | Group Differences in International Hip Outcome Score (IHOT33) to 24 Months | 44.9 score on a scale |
Other Pre-specified
Changes From Baseline Pain Catastrophizing Scale at 24 Months
The PCS is a 13-item patient-report scale developed to measure the extent to which people catastrophize in response to pain. Each item is scored from 0 ('not at all') to 4 ('all the time'). The PCS is reported as a total score, with higher scores indicating greater catastrophizing, and is composed of three sub-scales: Rumination (four items; e.g. 'When I am in pain, I keep thinking about how badly I want the pain to stop'), Magnification (three items; e.g. 'When I am in pain, I become afraid that the pain will get worse'), and Helplessness (six items; e.g. 'When I am in pain, I feel I can't go on'). The PCS has been shown to have high levels of internal consistency and construct validity.
Time frame: 24 months
Other Pre-specified
Self-Motivation Inventory
The Self-Motivation Inventory is an outcome measure that was developed to determine level of motivation. The Self-Motivation Inventory is a 40-item tool that has been found to measure an individual's tendency to persevere independent of situational reinforcement. It has also been used to predict successful weight loss and may correlate with number of sessions attended in weight loss program \[29\]. This tool underwent refinement in 1980 with the original 60-item tool being tested in undergraduate male and females. Items correlating less than 0.30 were deleted. The final 40-item scale yielded an exceptionally high internal reliability (α = 0.91) suggesting that a unitary common concept is evident for the obtained factor structure. The tool is widely used and has been tested in weight loss and therapeutic exercise studies
Time frame: Baseline