A Physical Therapy Program Versus Surgery for Femoroacetabular

Status Completed

Clinical 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. Enrollment is limited to patients that have already been determined surgical candidates. The study is following patients for a 2-year period.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01993615
Study type	Interventional
Source	Madigan Army Medical Center
Contact
Status	Completed
Phase	N/A
Start date	March 2013
Completion date	October 2016

View Details

See also
Status	Clinical Trial	Phase
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Active, not recruiting	`NCT03891563` - Prospective Evaluation of Sport Activity and the Development of Femoroacetabular Impingement in the Adolescent Hip
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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
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms