Femoroacetabular Impingement RandomiSed Controlled Trial

NCT01623843 | Completed DMC

• 1 other identifier: FIRST-01
• Study Type: interventional
• Target: 220
• Locations: 3 countries
• Sites: 10

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.

Conditions

Femoroacetabular Impingement

Keywords

FAI; randomized; hip arthroscopy; lavage; osteochondroplasty

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Function (measured using the Hip Outcome Score)

  12 months

• Health-related quality of life (measured using the Short-Form 12)

  12 months

• Function and lifestyle (measured using the International Hip Outcome Tool)

  12 months

• Health utility (measured using the Euro-Quol 5 Dimensions)

  12 months

• Urinary function (measured using the Male/Female Lower Urinary Tract Symptoms questionnaires)

  12 months

Study Arms (2)

Arthroscopic Lavage

ACTIVE COMPARATOR

Participants have three hip portals (antero-lateral, mid anterior, distal antero-lateral) with limited capsulotomy allowing for a complete assessment of the central and peripheral compartments. The participant has a diagnostic arthroscopy and lavage of the hip joint with three litres of normal saline. No osteochondroplasty or rim resection is completed in this group. No instruments are used to treat minor cartilage or labral damage. The labrum should only be repaired if mechanically unstable once probed with visible displacement or chondrolabral separation. The labrum will be refixated only if the above criteria for labral instability is met.

Procedure: Arthroscopic Lavage

Arthroscopic Osteochondroplasty

EXPERIMENTAL

After establishing standard portals, an inter-portal capsulotomy will be completed to allow for complete evaluation of the central compartment of the hip. Significant and obvious labral tears and cartilage damage will be addressed. The labrum will be repaired if mechanically unstable once probed with visible displacement or chondrolabral separation. The acetabular rim will be evaluated and any evident Pincer lesion will be resected using an arthroscopic burr under fluoroscopic guidance. Following this resection, the labrum will be refixated only if the criteria for labral instability is met. Following this, a limited capsulotomy will be completed along the head-neck junction of the femoral neck to allow for visualization and treatment of the impingement lesion in the peripheral compartment. For the FIRST-EPIC sub-study, participants will receive the osteochondroplasty intervention as per standard of care.

Procedure: Arthroscopic Osteochondroplasty

Interventions

Arthroscopic Lavage PROCEDURE

Lavage: inflammation debris caused from continual friction in the hip is washed out.

Arthroscopic Lavage

Arthroscopic Osteochondroplasty PROCEDURE

Osteochondroplasty: reshaping the hip ball and socket ("osteoplasty" or "rim trimming").

Arthroscopic Osteochondroplasty

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adult men or women ages 18 to 50 years
• Hip pain for greater than 6 months with no relief from non-operative means (physiotherapy, non-steroidal anti-inflammatory medication, rest)
• Documentation of failed physiotherapy, including core conditioning of the hip, back, and abdomen
• CAM or Mixed Type FAI as diagnosed on x-rays and magnetic resonance imaging (MRI) or magnetic resonance arthrogram (MRA)
• Temporary relief from an intra-articular hip injection
• Informed consent from participant
• Ability to speak, understand and read in the language of the clinical site

You may not qualify if:

• Evidence of hip dysplasia (centre edge angle less than 20)
• Presence of advanced hip osteoarthritis (Tonnis Grade 2 or 3)
• Presence of other hip syndromes (concurrent non-FAI related pathology)
• Previous trauma to the affected hip
• Previous surgery on the affected hip or contralateral hip
• Severe acetabular deformities (e.g. acetabular protrusion, coxa profunda, circumferential labral ossification)
• Immunosuppressive medication use
• Chronic pain syndromes
• Significant medical co-morbidities (requiring daily assistance for ADLs)
• History of paediatric hip disease (Legg-Calve-Perthes; slipped capital femoral epiphysis)
• Ongoing litigation or compensation claims secondary to hip problems
• 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.

Sponsors & Collaborators

• McMaster University: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• McMaster Surgical Associates: collaborator
• Canadian Orthopaedic Foundation: collaborator
• American Orthopaedic Society for Sports Medicine: collaborator

Study Sites (10)

Dalhousie University

Halifax, Nova Scotia, Canada

Location

McMaster University

Hamilton, Ontario, L8N 3Z5, Canada

Location

Kingston General Hospital

Kingston, Ontario, Canada

Location

Fowler Kennedy Sports Medicine Clinic

London, Ontario, Canada

Location

London Health Sciences

London, Ontario, Canada

Location

St. Michael's Hospital

Toronto, Ontario, Canada

Location

CHU de Québec, L'Hôtel-Dieu de Québec

Québec, Quebec, Canada

Location

Odense University Hospital

Odense, Denmark

Location

Hatanpää Hospital

Tampere, 33900, Finland

Location

Turku University Hospital

Turku, 20540, Finland

Location

Related Publications (20)

• Ganz R, Parvizi J, Beck M, Leunig M, Notzli H, Siebenrock KA. Femoroacetabular impingement: a cause for osteoarthritis of the hip. Clin Orthop Relat Res. 2003 Dec;(417):112-20. doi: 10.1097/01.blo.0000096804.78689.c2.

  PMID: 14646708 BACKGROUND

• 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.

  PMID: 19341926 BACKGROUND

• 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. doi: 10.1177/0363546507300258. Epub 2007 Apr 9.

  PMID: 17420508 BACKGROUND

• 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.

  PMID: 18442686 BACKGROUND

• 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.

  PMID: 20489213 BACKGROUND

• 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.

  PMID: 21266277 BACKGROUND

• 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.

  PMID: 19028166 BACKGROUND

• Clohisy JC, Carlisle JC, Beaule 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(Suppl 4):47-66. doi: 10.2106/JBJS.H.00756. No abstract available.

  PMID: 18984718 BACKGROUND

• 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. doi: 10.2214/AJR.06.0921.

  PMID: 17515374 BACKGROUND

• 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.

  PMID: 20410801 BACKGROUND

• Notzli 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. doi: 10.1302/0301-620x.84b4.12014.

  PMID: 12043778 BACKGROUND

• 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. doi: 10.1097/00005650-199603000-00003.

  PMID: 8628042 BACKGROUND

• 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. doi: 10.1097/01.blo.0000043047.84315.4b.

  PMID: 12579003 BACKGROUND

• 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.

  BACKGROUND

• Thorborg K, Roos EM, Bartels EM, Petersen J, Holmich 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.

  PMID: 19666629 BACKGROUND

• 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.

  PMID: 21035994 BACKGROUND

• Kay J, Simunovic N, Ayeni OR; FIRST Investigators; Bhandari M, Bedi A, Jarvinen T, Musahl V, Naudie D, Seppanen M, Slobogean G, Thabane L, Duong A, Skelly M, Shanmugaraj A, Crouch S, Sprague S, Heels-Ansdell D, Buckingham L, Ramsay T, Lee J, Kousa P, Carsen S, Choudur H, Sim Y, Johnston K, Wong I, Murphy R, Sparavalo S, Whelan D, Khan R, Wood GCA, Howells F, Grant H, Zomar B, Pollock M, Willits K, Firth A, Wanlin S, Remtulla A, Kaniki N, Belzile EL, Turmel S, Jorgensen U, Gam-Pedersen A, Sihvonen R, Raivio Sihvonen M, Toivonen Sihvonen P, Pirjetta Routapohja M. Effect of Osteochondroplasty on Time to Reoperation After Arthroscopic Management of Femoroacetabular Impingement: Analysis of a Randomized Controlled Trial. Orthop J Sports Med. 2022 Apr 5;10(4):23259671211041400. doi: 10.1177/23259671211041400. eCollection 2022 Apr.

  PMID: 35400136 DERIVED

• Femoroacetabular Impingement Randomized Controlled Trial (FIRST) Investigators; Ayeni OR, Karlsson J, Heels-Ansdell D, Thabane L, Musahl V, Simunovic N, Duong A, Bhandari M, Bedi A, Jarvinen T, Naudie D, Seppanen M, Slobogean G, Skelly M, Shanmugaraj A, Crouch S, Sprague S, Buckingham L, Ramsay T, Lee J, Kousa P, Carsen S, Choudur H, Sim Y, Johnston K, Sprague S, Wong I, Murphy R, Sparavalo S, Whelan D, Khan R, Wood GCA, Howells F, Grant H, Naudie D, Zomar B, Pollock M, Willits K, Firth A, Wanlin S, Remtulla A, Kaniki N, Belzile EL, Turmel S, Jorgensen U, Gam-Pedersen A, Hatanpaa T, Sihvonen R, Raivio M, Toivonen P, Routapohja MP. Osteochondroplasty and Labral Repair for the Treatment of Young Adults With Femoroacetabular Impingement: A Randomized Controlled Trial. Am J Sports Med. 2021 Jan;49(1):25-34. doi: 10.1177/0363546520952804. Epub 2020 Sep 24.

  PMID: 32970955 DERIVED

• Simunovic N, Heels-Ansdell D, Thabane L, Ayeni OR; FIRST Investigators. Femoroacetabular Impingement Randomised controlled Trial (FIRST) - a multi-centre randomized controlled trial comparing arthroscopic lavage and arthroscopic osteochondroplasty on patient important outcomes and quality of life in the treatment of young adult (18-50 years) femoroacetabular impingement: a statistical analysis plan. Trials. 2018 Oct 29;19(1):588. doi: 10.1186/s13063-018-2965-0.

  PMID: 30373659 DERIVED

• FIRST Investigators. A multi-centre randomized controlled trial comparing arthroscopic osteochondroplasty and lavage with arthroscopic lavage alone on patient important outcomes and quality of life in the treatment of young adult (18-50) femoroacetabular impingement. BMC Musculoskelet Disord. 2015 Mar 20;16:64. doi: 10.1186/s12891-015-0500-y.

  PMID: 25886958 DERIVED

MeSH Terms

Conditions

Femoracetabular Impingement

Condition Hierarchy (Ancestors)

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

Study Officials

• Olufemi Ayeni, MD, MSc, FRCSC

  McMaster Univerity

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2012
• First Posted: June 20, 2012
• Study Start: September 1, 2012
• Primary Completion: December 1, 2019
• Study Completion: March 1, 2020
• Last Updated: August 25, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (7); DK (1); FI (2)