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

NCT01993615 | Completed Results DMC

• 1 other identifier: 213011
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Femoroacetabular Impingement

Keywords

FAI; femoroacetabular impingement; hip pain; hip arthroscopy; physical therapy

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Group Differences in International Hip Outcome Score (IHOT33) to 24 Months

  24 months

• Global Rating of Change Score of 3+ or Higher (Minimum Clinically Important Change)

  24 months

Other Outcomes (2)

• Self-Motivation Inventory

  Baseline

• Changes From Baseline Pain Catastrophizing Scale at 24 Months

  24 months

Study Arms (2)

Arthroscopic Surgery

ACTIVE COMPARATOR

Arthroscopic surgery at the femoroacetabular joint, followed by a standardized post-operative rehabilitation protocol in physical therapy.

Procedure: Arthroscopic Surgery

Physical Therapy

ACTIVE COMPARATOR

An impairment-based supervised in-clinic physical therapy program.

Procedure: Physical Therapy

Interventions

Arthroscopic Surgery PROCEDURE

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.

Arthroscopic Surgery

Physical Therapy PROCEDURE

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.

Physical Therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Madigan Army Medical Center: lead

Study Sites (1)

Madigan Army Medical Center

Tacoma, Washington, 98431, United States

Location

Related Publications (2)

• 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.

  PMID: 29443538 DERIVED

• 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.

  PMID: 26846934 DERIVED

MeSH Terms

Conditions

Femoracetabular Impingement

Interventions

Arthroscopy; Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Orthopedic Procedures; Therapeutics; Rehabilitation

Results Point of Contact

• Title: Daniel Rhon
• Organization: Madigan Army Medical Center

daniel.i.rhon.ctr@mail.mil

253-968-0780

Study Officials

• Nancy Mansell, PT, DPT

  Madigan Army Medical Center

  PRINCIPAL INVESTIGATOR

• Daniel Rhon, DPT, DSc

  Madigan Army Medical Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Physical Therapy, Department of PM&R

Study Record Dates

• First Submitted: October 30, 2013
• First Posted: November 25, 2013
• Study Start: March 1, 2013
• Primary Completion: July 1, 2016
• Study Completion: October 1, 2016
• Last Updated: August 14, 2020
• Results First Posted: August 14, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will share

Locations

US (1)