Femoroacetabular Impingement Clinical Trial
Official title:
A Supervised Physical Therapy Program vs. Arthroscopic Surgery for Femoroacetabular Impingement: A Randomized Clinical Trial
NCT number | NCT01993615 |
Other study ID # | 213011 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 2013 |
Est. completion date | October 2016 |
Verified date | July 2020 |
Source | Madigan Army Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 80 |
Est. completion date | October 2016 |
Est. primary completion date | July 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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) |
Country | Name | City | State |
---|---|---|---|
United States | Madigan Army Medical Center | Tacoma | Washington |
Lead Sponsor | Collaborator |
---|---|
Madigan Army Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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 (a = 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 | |
Other | 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. | 24 months | |
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). | 24 months | |
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. | 24 months | |
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. | 24 months | |
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. | 24 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01623843 -
Femoroacetabular Impingement RandomiSed Controlled Trial
|
N/A | |
Completed |
NCT03669471 -
Muscular and Functional Performance in FAIS Patients
|
||
Not yet recruiting |
NCT05031390 -
the Horsens Aarhus FemoroAcetabular Impingement Syndrome Training Pilot Study
|
N/A | |
Active, not recruiting |
NCT05025956 -
Senolytic Agent Improve the Benefit of Platelet-Rich Plasma and Losartan
|
Phase 1/Phase 2 | |
Withdrawn |
NCT02674113 -
Regional Anesthesia in Hip Arthroscopy
|
N/A | |
Withdrawn |
NCT02260726 -
Evaluation of Ultrasound for Detecting Hip Impingement
|
N/A | |
Recruiting |
NCT05391204 -
Reproducibility of Strength Testing and Functional Testing of the Hip for the Return to Sport of Patients Activated by a Femoroacetabular Impingement: Comparison Between a Group of Patients and a Group of Healthy Controls
|
N/A | |
Active, not recruiting |
NCT03891563 -
Prospective Evaluation of Sport Activity and the Development of Femoroacetabular Impingement in the Adolescent Hip
|
||
Active, not recruiting |
NCT04069507 -
Healthy Hip Study: Conservative Management for Pre-arthritic Hip Disorders
|
||
Terminated |
NCT03278353 -
Fulfillment of Expectations for Patients With FAI Syndrome
|
N/A | |
Terminated |
NCT03995290 -
3D Modeling to Improve Hip Arthroscopy Outcomes
|
||
Completed |
NCT06082271 -
Comparative, Randomized Study on the Anti-inflammatory and Regenerative Efficacy of a New Medical Device (DM) Based on Hydrolyzed Collagen Peptides in Patients With Femoro-acetabular Impingement Undergoing Hip Arthroscopy
|
N/A | |
Recruiting |
NCT01621360 -
Hip Arthroscopy Versus Conservative Management of Femoroacetabular Impingement
|
N/A | |
Completed |
NCT04980209 -
The Feasibility and Application of Intraoperative Ultrasound to Evaluate Femoral Head Shaping
|
||
Enrolling by invitation |
NCT04988659 -
Analysis of Gene Expression in Femoroacetabular Impingement (FAI)
|
||
Active, not recruiting |
NCT03494660 -
SCP Hip Outcomes Study
|
||
Active, not recruiting |
NCT04822571 -
Investigating the Reliability of Highly Dynamic 3D Motion Analysis Protocol in Adolescence and Adult Males
|
N/A | |
Withdrawn |
NCT02706756 -
Conservative Intervention of Femoroacetabular Impingement Syndrome
|
N/A | |
Completed |
NCT02702661 -
PRCT of FICB vs LAI for Hip Arthroscopy
|
N/A | |
Completed |
NCT01814124 -
Conservative Management of Femoroacetabular Impingement
|
N/A |