- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01993615
A Physical Therapy Program Versus Surgery for Femoroacetabular Impingement: Randomized Clinical Trial
A Supervised Physical Therapy Program vs. Arthroscopic Surgery for Femoroacetabular Impingement: A Randomized Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Washington
-
Tacoma, Washington, United States, 98431
- Madigan Army Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Arthroscopic Surgery
Arthroscopic surgery at the femoroacetabular joint, followed by a standardized post-operative rehabilitation protocol in physical therapy.
|
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.
|
ACTIVE_COMPARATOR: Physical Therapy
An impairment-based supervised in-clinic physical therapy program.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hip Outcome Score - ADL Subscale at 24 Months
Time Frame: 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).
|
24 months
|
Hip Outcome Score - Sport Subscale at 24 Months
Time Frame: 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.
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Group Differences in International Hip Outcome Score (IHOT33) to 24 Months
Time Frame: 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.
|
24 months
|
Global Rating of Change Score of 3+ or Higher (Minimum Clinically Important Change)
Time Frame: 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.
|
24 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self-Motivation Inventory
Time Frame: 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
|
Baseline
|
Changes From Baseline Pain Catastrophizing Scale at 24 Months
Time Frame: 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.
|
24 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nancy Mansell, PT, DPT, Madigan Army Medical Center
- Study Chair: Daniel Rhon, DPT, DSc, Madigan Army Medical Center
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 213011
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Femoroacetabular Impingement
-
Ottawa Hospital Research InstituteCompleted
-
Schulthess KlinikCompletedSymptomatic Femoroacetabular ImpingementSwitzerland
-
Ottawa Hospital Research InstituteCompletedFemoroacetabular Hip Impingement SyndromeCanada
-
NYU Langone HealthCompletedFemoroacetabular ImpingementUnited States
-
Peking University Third HospitalEnrolling by invitationFemoroacetabular ImpingementChina
-
Hvidovre University HospitalDuke University; La Trobe UniversityUnknownFemoroacetabular ImpingementDenmark
-
University of MichiganTerminatedFemoroacetabular ImpingementUnited States
-
University of Missouri-ColumbiaWithdrawn
-
University of Western Ontario, CanadaUnknownFemoroacetabular ImpingementCanada
-
Ramsay Générale de SantéRamsay santéRecruiting
Clinical Trials on Arthroscopic Surgery
-
University of Southern DenmarkOdense University Hospital; Lillebaelt Hospital, Kolding and Vejle, DenmarkCompletedKnee Osteoarthritis | Meniscus InjuryDenmark
-
University of AarhusHorsens HospitalTerminatedFemoracetabular Impingement | Hip PathologyDenmark
-
University of AarhusAarhus University Hospital; Horsens HospitalCompletedFemoracetabular ImpingementDenmark
-
Tego Science, Inc.CompletedRotator Cuff InjuriesKorea, Republic of
-
Royal National Orthopaedic Hospital NHS TrustUniversity of SydneyCompletedAtraumatic Shoulder InstabilityUnited Kingdom
-
University of Western Ontario, CanadaCanadian Institutes of Health Research (CIHR)CompletedOsteoarthritis of the KneeCanada
-
Fondren Orthopedic Group L.L.P.InGeneron, Inc.CompletedArticular Cartilage Defect Grade III or IV of the KneeUnited States
-
Smith & Nephew, Inc.TerminatedRotator Cuff InjuriesUnited States, Hong Kong, United Kingdom, France, Singapore, Switzerland, Australia, Canada
-
University Hospital, GhentWithdrawn