Femoroacetabular ImpingementNCT01993615

A Physical Therapy Program Versus Surgery for Femoroacetabular Impingement: Randomized Clinical Trial

A study testing Arthroscopic Surgery and Physical Therapy in people with Femoroacetabular Impingement, run by Madigan Army Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Femoroacetabular Impingement
What is being tested?: Arthroscopic Surgery and Physical Therapy
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: 1 siteUnited States
Study dates: Mar 2013to Oct 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Show all 10Show fewer

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

Who cannot join

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

Show all 9Show fewer

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)

Trial locations and contacts

1 site in 1 country.

United States1 site

Madigan Army Medical Center
Tacoma, Washington, 98431

Other trials in United States

About this study

Official title: A Supervised Physical Therapy Program vs. Arthroscopic Surgery for Femoroacetabular Impingement: A Randomized Clinical Trial

Read the 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.

Conditions: Femoroacetabular Impingement
Being tested: Arthroscopic Surgery, Physical Therapy
Keywords: FAI, femoroacetabular impingement, hip pain, hip arthroscopy, physical therapy
Medical subject headings: Femoracetabular Impingement

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Arthroscopic SurgeryProcedure or 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.
Physical TherapyProcedure or surgery
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.

Study groups in NCT01993615
Study group	Role	What they receive
Arthroscopic Surgery	Active comparator	Arthroscopic surgery at the femoroacetabular joint, followed by a standardized post-operative rehabilitation protocol in physical therapy. Receives: Procedure: Arthroscopic Surgery
Physical Therapy	Active comparator	An impairment-based supervised in-clinic physical therapy program. Receives: Procedure: Physical Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 24 months
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.
Measured: 24 months

Secondary outcomes (2)

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.
Measured: 24 months
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.
Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2013Oct 2016

First posted25 Nov 2013 (estimated)
Study startMar 2013
Primary completionJul 2016
Study completionOct 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Femoroacetabular ImpingementStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01993615
Sponsor's protocol ID: 213011
Status last verified: Jul 2020
First submitted: 30 Oct 2013
Last updated: 14 Aug 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Yes: Any data sharing must go through a Data Sharing Agreement approved by the US Defense Health Agency

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.
PubMed 29443538
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.
PubMed 26846934

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Comparison of Surgery With Prehabilitation, Direct Surgery and Rehabilitation for Patients With Femoroacetabular Impingement
Femoroacetabular Impingement Syndrome
Not yet recruitingObservational study
Mapping Joint Damage Patterns in Femoroacetabular Impingement
Femoro-acetabular Impingement (FAI)
Active, not recruiting
Early Feasibility Study of Cartilage Defect Repair
Osteoarthritis, Hip, Femoroacetabular Impingement
Not yet recruiting
Labral Repair vs Reconstruction
Femoral Acetabular Impingement
Not yet recruiting
3D MRI Assessment of Femoroacetabular Impingement in Patients With ACL Rupture - Exploratory Study
Femoroacetabular Impingement

All Femoroacetabular Impingement trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Supervised Physical Therapy Program vs. Arthroscopic Surgery for Femoroacetabular Impingement: A Randomized Clinical Trial
ClinicalTrials.gov ID: NCT01993615
Acronym / sponsor ID: 213011
Conditions: Femoroacetabular Impingement
Keywords: FAI, femoroacetabular impingement, hip pain, hip arthroscopy, physical therapy
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: Madigan Army Medical CenterUS federal agency
Study start: Mar 2013 (actual)
Primary completion: Jul 2016 (actual)
Study completion: Oct 2016 (actual)
First posted: 25 Nov 2013 (estimated)
Results: Posted 14 Aug 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Arthroscopic Surgery	Active comparator	Procedure: Arthroscopic SurgeryArthroscopic surgery at the femoroacetabular joint, followed by a standardized post-operative rehabilitation protocol in physical therapy.
Physical Therapy	Active comparator	Procedure: Physical TherapyAn impairment-based supervised in-clinic physical therapy program.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Tricare beneficiaries between the ages of 18 and 65
Diagnosis of FAI and/or labral pathology confirmed by a combination of the following:
Surgical candidate for hip arthroscopy defined by (must have both):
Failed 6 weeks of conservative management

Key exclusion criteria (9 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Arthroscopic SurgeryThe 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.	Procedure or surgery	Arthroscopic Surgery
Physical TherapySubjects 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.	Procedure or surgery	Physical Therapy

Primary outcome

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).
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.

2 secondary outcomes

Group Differences in International Hip Outcome Score (IHOT33) to 24 Months
Time frame: 24 months
Global Rating of Change Score of 3+ or Higher (Minimum Clinically Important Change)
Time frame: 24 months

Results and safety

Results posted to the registry on 14 Aug 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arthroscopic Surgery	40	39
Physical Therapy	40	40

Primary outcome: Hip Outcome Score - ADL Subscale at 24 Months

Time frame: 24 months. Least squares mean (95% Confidence Interval). Unit: score on a scale

Measure	Arthroscopic Surgery n = 37	Physical Therapy n = 37
Value	69.3 (62.5 to 76.2)	73.1 (66.1 to 80.3)

Population analysed: Intention to treat analysis including only participants that received any treatment (6 participants that were enrolled never returned for treatment)

Primary outcome: Hip Outcome Score - Sport Subscale at 24 Months

Time frame: 24 months. Least squares mean (95% Confidence Interval). Unit: score on a scale

Measure	Arthroscopic Surgery n = 37	Physical Therapy n = 37
Value	55.3 (46.2 to 64.4)	57.1 (47.8 to 66.3)

Population analysed: Intention to treat analysis including only participants that received any treatment (6 participants that were enrolled never returned for treatment)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 2 years. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arthroscopic Surgery	0 of 40 (0%)	2 of 40 (5%)	1 of 40
Physical Therapy	0 of 40 (0%)	2 of 40 (5%)	0 of 40

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 29443538Mansell 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.
Derived from this study: PubMed 26846934Mansell 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.
Individual participant dataSharing planned: Yes. Any data sharing must go through a Data Sharing Agreement approved by the US Defense Health Agency

Related trials for Femoroacetabular Impingement

Recruiting
Comparison of Surgery With Prehabilitation, Direct Surgery and Rehabilitation for Patients With Femoroacetabular Impingement
Femoroacetabular Impingement Syndrome
Not yet recruitingObservational study
Mapping Joint Damage Patterns in Femoroacetabular Impingement
Femoro-acetabular Impingement (FAI)
Active, not recruiting
Early Feasibility Study of Cartilage Defect Repair
Osteoarthritis, Hip, Femoroacetabular Impingement
Not yet recruiting
Labral Repair vs Reconstruction
Femoral Acetabular Impingement
Not yet recruiting
3D MRI Assessment of Femoroacetabular Impingement in Patients With ACL Rupture - Exploratory Study
Femoroacetabular Impingement

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Nancy Mansell, PT, DPT principal investigator

Madigan Army Medical Center

Daniel Rhon, DPT, DSc study chair

Madigan Army Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Arthroscopic Surgery and Physical Therapy in people with Femoroacetabular Impingement, run by Madigan Army Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hip Outcome Score - ADL Subscale at 24 Months (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01993615, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2020.