Clinical Trial: Femoroacetabular Impingement RandomiSed Controlled Trial

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Femoroacetabular Impingement RandomiSed Controlled Trial (FIRST)

Brief Summary: The purpose of this study is to determine whether surgical correction of hip impingement morphology via arthroscopic osteochondroplasty (shaving of bone) will provide improved clinical results (decreased pain and improved function) in adult patients with femoroacetabular impingement (FAI) compared to arthroscopic lavage (washing out of painful inflammation debris) and treating obvious damage of the hip joint.

Detailed Summary: Femoroacetabular impingement (FAI) is a condition of the hip where there is a mismatch of the ball and socket in the hip joint. This mismatch creates abnormal contact in the hip which can cause patients to experience hip pain. This can eventually lead to hip damage and osteoarthritis. Hip arthroscopy, a form of minimally invasive surgery has become a popular treatment option. The investigators are conducting a definitive randomized controlled trial (RCT) to determine whether surgical correction of the impingement morphology via arthroscopic osteochondroplasty (shaving of bone) will provide improved clinical results (decreased pain and improved function) in adult FAI patients compared to arthroscopic lavage (washing out of painful inflammation debris) and treating obvious damage of the hip joint.
Sponsor: McMaster University

Current Primary Outcome: Pain (measured using a Visual Analog Scale) [ Time Frame: 12 months ]

The VAS is one of the most frequently used pain rating scales in clinical practice and research. The VAS is a validated unidimensional scale that is easy to use, requires no verbal or reading skills, and is sufficiently versatile to be employed in a variety of settings. The VAS will be administered during routine follow up visits at baseline, 2 weeks, 6 weeks, 3 months, 6 months, and 12 months.


Original Primary Outcome: Feasibility of definitive trial [ Time Frame: 2 years ]

Complete patient recruitment by 1 year, 100 % patient follow up at 1 year and study completion by 2 years, documentation of compliance with protocol and finalization of data capture manual and system for definitive RCT


Current Secondary Outcome:

  • Health related quality of life (measured using the SF-12) [ Time Frame: 12 months ]
    The SF-12 may be self or interview-administered and will help document general health status as well as the burden of illness that FAI presents. The SF-12 will be administered during routine follow up visits at baseline, 2 weeks, 6 weeks, 3 months, 6 months, and 12 months.
  • Function (measured using the HOS and iHOT-12) [ Time Frame: 12 months ]
    The HOS is a self-administered hip score that was designed to capture hip function and outcomes following surgical therapies such as arthroscopy. The HOS has been shown to have the greatest clinimetric evidence for use in patients with FAI or labral tears. The iHOT-12 is a shorter version of the iHOT-33 designed to be easier to complete in routine clinical practice to measure both health-related quality of life and changes after treatment in young, active patients with hip disorders. The HOS and iHOT-12 will be administered during routine follow up visits at baseline, 2 weeks, 6 weeks, 3 months, 6 months, and 12 months.
  • Health utility (measured using the EQ-5D) [ Time Frame: 12 months ]
    The EQ-5D is a standardized instrument for use as a measure of health outcome. The EQ-5D comprises five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). The EQ-5D has been used in previous studies involving patients with hip pain and has been extensively validated. The questionnaire is validated for use in all countries where our trial centres are located. The EQ-5D will be administered during routine follow up visits at baseline, 2 weeks, 6 weeks, 3 months, 6 months, and 12 months.
  • Sexual and urinary function (measured using the IIEF, FSFI, ICIQ-MLUTS, ICIQ-FLUTS) [ Time Frame: 12 months ]
    The two validated questionnaires selected that pertain to male and female urinary symptoms are gender specific variations of the International Consultation on Continence Questionnaire (ICIQ). These are validated patient-completed questionnaires, which evaluate male and female lower urinary tract symptoms (LUTS), as well as quality of life. The two validated measurement instruments that will assess male and female sexual function are: The Female Sexual Function Index (FSFI), and the International Index of Erectile Function (IIEF). These questionnaires will be administered during routine follow up visits at baseline, 2 weeks, 6 weeks, 3 months, 6 months, and 12 months.
  • Complications/adverse events [ Time Frame: 12 months ]
    Complications, including additional surgery, infection, reduced range of motion, and other adverse events will be recorded throughout the 12 month follow-up.


Original Secondary Outcome:

  • Change in pain scores at 6 months using visual rating scale [ Time Frame: 6 months ]
  • Change in Heath Status and Function using SF-12, NAHS and HOS questionnaires [ Time Frame: 1 year ]


Information By: McMaster University

Dates:
Date Received: June 17, 2012
Date Started: September 2012
Date Completion: June 2017
Last Updated: September 13, 2016
Last Verified: September 2016