Femoroacetabular Impingement RandomiSed Controlled Trial

Femoroacetabular Impingement Clinical Trial

— FIRST  

Official title:

Femoroacetabular Impingement RandomiSed Controlled Trial (FIRST); Sub-study: Femoroacetabular Impingement RandomiSed Controlled Trial With an Embedded Prospective Cohort (FIRST-EPIC)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01623843
• Other study ID #: FIRST-01
• Status: Completed
• Phase: N/A
• Start date: September 2012
• Est. completion date: March 2020

Study information

• Verified date: August 2020
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Like most RCTs, FIRST is designed to demonstrate efficacy (i.e. that an intervention can work theoretically under optimal conditions). In order to address generalizability and improve external validity of the FIRST trial, we are including an external validation cohort using a "RCT with and Embedded ProspectIve Cohort design" (FIRST-EPIC). This pragmatic cohort will allow us to: 1) safeguard against bias attributable to patients declining to take part in the RCT; 2) corroborate or refute whether our efficacy (RCT) population represents the best case scenario (i.e. those with optimal response to osteochondroplasty); 3) evaluate effectiveness of osteochondroplasty and other standard of care treatments for FAI in patients with potentially distinct prognostic factors; and 4) evaluate the cost-effectiveness of the interventions.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: March 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

1. Adult men or women ages 18 to 50 years

2. Hip pain for greater than 6 months with no relief from non-operative means (physiotherapy, non-steroidal anti-inflammatory medication, rest)

3. Documentation of failed physiotherapy, including core conditioning of the hip, back, and abdomen

4. CAM or Mixed Type FAI as diagnosed on x-rays and magnetic resonance imaging (MRI) or magnetic resonance arthrogram (MRA)

5. Temporary relief from an intra-articular hip injection

6. Informed consent from participant

7. Ability to speak, understand and read in the language of the clinical site

Exclusion Criteria:

1. Previous inclusion in a study involving FAI

2. Evidence of hip dysplasia (centre edge angle less than 20)

3. Presence of advanced hip osteoarthritis (Tonnis Grade 2 or 3)

4. Presence of other hip syndromes (concurrent non-FAI related pathology)

5. Previous trauma to the affected hip

6. Previous surgery on the affected hip or contralateral hip

7. Severe acetabular deformities (e.g. acetabular protrusion, coxa profunda, circumferential labral ossification)

8. Immunosuppressive medication use

9. Chronic pain syndromes

10. Significant medical co-morbidities (requiring daily assistance for ADLs)

11. History of paediatric hip disease (Legg-Calve-Perthes; slipped capital femoral epiphysis)

12. Ongoing litigation or compensation claims secondary to hip problems

13. Any other reasons given to exclude the patient

• If a patient does not meet the eligibility criteria for the FIRST trial, they may be considered eligible for the FIRST-EPIC sub-study.

Related Conditions & MeSH terms

• Femoracetabular Impingement
• Femoroacetabular Impingement

Intervention

Procedure:
• Arthroscopic Lavage
Lavage: inflammation debris caused from continual friction in the hip is washed out.
• Arthroscopic Osteochondroplasty
Osteochondroplasty: reshaping the hip ball and socket ("osteoplasty" or "rim trimming").

Locations

Country	Name	City	State
Canada	Dalhousie University	Halifax	Nova Scotia
Canada	McMaster University	Hamilton	Ontario
Canada	Kingston General Hospital	Kingston	Ontario
Canada	Fowler Kennedy Sports Medicine Clinic	London	Ontario
Canada	London Health Sciences	London	Ontario
Canada	CHU de Québec, L'Hôtel-Dieu de Québec	Quebec City	Quebec
Canada	St. Michael's Hospital	Toronto	Ontario
Denmark	Odense University Hospital	Odense
Finland	Hatanpää Hospital	Tampere
Finland	Turku University Hospital	Turku

Sponsors (5)

Lead Sponsor	Collaborator
McMaster University	American Orthopaedic Society for Sports Medicine, Canadian Institutes of Health Research (CIHR), Canadian Orthopaedic Foundation, McMaster Surgical Associates

Countries where clinical trial is conducted

Canada,  Denmark,  Finland, 

References & Publications (16)

Anderson SE, Siebenrock KA, Mamisch TC, Tannast M. Femoroacetabular impingement magnetic resonance imaging. Top Magn Reson Imaging. 2009 Jun;20(3):123-8. doi: 10.1097/RMR.0b013e3181d99459. Review. — View Citation

Bedi A, Chen N, Robertson W, Kelly BT. The management of labral tears and femoroacetabular impingement of the hip in the young, active patient. Arthroscopy. 2008 Oct;24(10):1135-45. doi: 10.1016/j.arthro.2008.06.001. Review. — View Citation

Botser IB, Smith TW Jr, Nasser R, Domb BG. Open surgical dislocation versus arthroscopy for femoroacetabular impingement: a comparison of clinical outcomes. Arthroscopy. 2011 Feb;27(2):270-8. doi: 10.1016/j.arthro.2010.11.008. Review. — View Citation

Christensen CP, Althausen PL, Mittleman MA, Lee JA, McCarthy JC. The nonarthritic hip score: reliable and validated. Clin Orthop Relat Res. 2003 Jan;(406):75-83. — View Citation

Clohisy JC, Carlisle JC, Beaulé PE, Kim YJ, Trousdale RT, Sierra RJ, Leunig M, Schoenecker PL, Millis MB. A systematic approach to the plain radiographic evaluation of the young adult hip. J Bone Joint Surg Am. 2008 Nov;90 Suppl 4:47-66. doi: 10.2106/JBJS.H.00756. — View Citation

Ganz R, Parvizi J, Beck M, Leunig M, Nötzli H, Siebenrock KA. Femoroacetabular impingement: a cause for osteoarthritis of the hip. Clin Orthop Relat Res. 2003 Dec;(417):112-20. Review. — View Citation

Larson CM, Giveans MR. Arthroscopic management of femoroacetabular impingement: early outcomes measures. Arthroscopy. 2008 May;24(5):540-6. doi: 10.1016/j.arthro.2007.11.007. Epub 2008 Jan 7. — View Citation

Lincoln M, Johnston K, Muldoon M, Santore R. Combined arthroscopic and modified open approach for cam femoroacetabular impingement: a preliminary experience. Arthroscopy. 2009 Apr;25(4):392-9. doi: 10.1016/j.arthro.2008.12.002. — View Citation

Lodhia P, Slobogean GP, Noonan VK, Gilbart MK. Patient-reported outcome instruments for femoroacetabular impingement and hip labral pathology: a systematic review of the clinimetric evidence. Arthroscopy. 2011 Feb;27(2):279-86. doi: 10.1016/j.arthro.2010.08.002. Epub 2010 Oct 29. Review. — View Citation

Ng VY, Arora N, Best TM, Pan X, Ellis TJ. Efficacy of surgery for femoroacetabular impingement: a systematic review. Am J Sports Med. 2010 Nov;38(11):2337-45. doi: 10.1177/0363546510365530. Epub 2010 May 20. Review. — View Citation

Nötzli HP, Wyss TF, Stoecklin CH, Schmid MR, Treiber K, Hodler J. The contour of the femoral head-neck junction as a predictor for the risk of anterior impingement. J Bone Joint Surg Br. 2002 May;84(4):556-60. — View Citation

Philippon MJ, Stubbs AJ, Schenker ML, Maxwell RB, Ganz R, Leunig M. Arthroscopic management of femoroacetabular impingement: osteoplasty technique and literature review. Am J Sports Med. 2007 Sep;35(9):1571-80. Epub 2007 Apr 9. Review. — View Citation

Schenker ML, Martin R, Weiland DE, Philippon MJ. Current trends in hip arthroscopy: a review of injury diagnosis, techniques and outcome scoring. Current opinion in orthopeadics.2005;16:89-94.

Tannast M, Siebenrock KA, Anderson SE. Femoroacetabular impingement: radiographic diagnosis--what the radiologist should know. AJR Am J Roentgenol. 2007 Jun;188(6):1540-52. Review. — View Citation

Thorborg K, Roos EM, Bartels EM, Petersen J, Hölmich P. Validity, reliability and responsiveness of patient-reported outcome questionnaires when assessing hip and groin disability: a systematic review. Br J Sports Med. 2010 Dec;44(16):1186-96. doi: 10.1136/bjsm.2009.060889. Epub 2009 Aug 6. Review. — View Citation

Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain (measured using a Visual Analog Scale)	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.	12 months
Secondary	Function (measured using the Hip Outcome Score)	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.	12 months
Secondary	Health-related quality of life (measured using the Short-Form 12)	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.	12 months
Secondary	Function and lifestyle (measured using the International Hip Outcome Tool)	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. This questionnaire has been shown to be valid, reliable, and responsive to change.	12 months
Secondary	Health utility (measured using the Euro-Quol 5 Dimensions)	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. Our decision to the use EQ-5D was based upon our interest in collecting health utility data for a formal economic analysis.	12 months
Secondary	Urinary function (measured using the Male/Female Lower Urinary Tract Symptoms questionnaires)	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). The ICIQ-MLUTS (male) and ICIQ-FLUTS (female). These are validated patient-completed questionnaires, which evaluate male and female lower urinary tract symptoms (LUTS), as well as quality of life. Both questionnaires have demonstrated validity, reliability and responsiveness internally and externally.	12 months
Secondary	Sexual function (measured using the International Index of Erectile Dysfunction and the Female Sexual Function Index)	The FSFI is a brief psychometrically sound and reliable tool that assesses female sexual function, and has proven ability to discriminate between clinical and nonclinical populations.The FSFI is also designed to measure the impact on quality of life. The IIEF is a brief self-administered questionnaire assessing sexual experience within the previous 4 weeks, consisting of 15 questions designed to address 5 relevant aspects of male sexual function, specifically erectile function, sexual desire, orgasmic function, intercourse satisfaction and overall satisfaction. This instrument is psychometrically sound with high sensitivity and specificity, which has been validated for administration in research and clinical settings, and across cultures with linguistically validated versions.	12 months
Secondary	Complications / Adverse events	Includes additional surgery, infection, reduced range of motion, and other adverse events	12 and 24 months