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Femoroacetabular ImpingementFIRSTNCT01623843

Femoroacetabular Impingement RandomiSed Controlled Trial

A study testing Arthroscopic Lavage and Arthroscopic Osteochondroplasty in people with Femoroacetabular Impingement, run by McMaster University at 10 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 50 years
Conditions the study is for
Femoroacetabular Impingement
What is being tested?
Arthroscopic Lavage and Arthroscopic Osteochondroplasty
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
220 participants
Where
10 sitesin 3 countries
Study dates
Sep 2012to Mar 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • Previous inclusion in a study involving FAI
  • 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
Show all 14Show fewer
  • 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.

Trial locations and contacts

10 sites in 3 countries.

10 sites in 3 countries

Canada7 sites

  • Dalhousie University

    Halifax, Nova Scotia

  • McMaster University

    Hamilton, Ontario, L8N 3Z5

  • Kingston General Hospital

    Kingston, Ontario

  • Fowler Kennedy Sports Medicine Clinic

    London, Ontario

  • London Health Sciences

    London, Ontario

  • CHU de Québec, L'Hôtel-Dieu de Québec

    Québec, Quebec

  • St. Michael's Hospital

    Toronto, Ontario

Other trials in Canada

Finland2 sites

  • Hatanpää Hospital

    Tampere, 33900

  • Turku University Hospital

    Turku, 20540

Other trials in Finland

Denmark1 site

  • Odense University Hospital

    Odense

Other trials in Denmark

About this study

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

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.

Read the detailed 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.

Being tested
Arthroscopic Lavage, Arthroscopic Osteochondroplasty
Keywords
FAI, randomized, hip arthroscopy, lavage, osteochondroplasty
Medical subject headings
Femoracetabular Impingement

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Arthroscopic LavageProcedure or surgery

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

  • Arthroscopic OsteochondroplastyProcedure or surgery

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

Study groups in NCT01623843
Study groupRoleWhat they receive
Arthroscopic LavageActive comparatorParticipants 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.
Receives: Procedure: Arthroscopic Lavage
Arthroscopic OsteochondroplastyExperimentalAfter 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.
Receives: Procedure: Arthroscopic Osteochondroplasty

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 months

Secondary outcomes (7)

  1. 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.

    Measured: 12 months

  2. 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.

    Measured: 12 months

  3. 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.

    Measured: 12 months

  4. 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.

    Measured: 12 months

  5. 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.

    Measured: 12 months

  6. 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.

    Measured: 12 months

  7. Complications / Adverse events

    Includes additional surgery, infection, reduced range of motion, and other adverse events

    Measured: 12 and 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jun 2012 (estimated)
  2. Study startSep 2012
  3. Primary completionDec 2019
  4. Study completionMar 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
220 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01623843
Sponsor's protocol ID
FIRST-01
Acronym
FIRST
Status last verified
Aug 2020
First submitted
17 Jun 2012
Last updated
25 Aug 2020
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 14646708

  • 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.

    PubMed 19341926

  • 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.

    PubMed 17420508

  • 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.

    PubMed 18442686

  • 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.

    PubMed 20489213

  • 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.

    PubMed 21266277

  • 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.

    PubMed 19028166

  • 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.

    PubMed 18984718

  • 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.

    PubMed 17515374

  • 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.

    PubMed 20410801

  • 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.

    PubMed 12043778

  • 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.

    PubMed 8628042

  • 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.

    PubMed 12579003

  • 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.

  • 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.

    PubMed 19666629

Questions about this trial

What is this clinical trial studying?

A study testing Arthroscopic Lavage and Arthroscopic Osteochondroplasty in people with Femoroacetabular Impingement, run by McMaster University at 10 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Canada, Finland, Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain (measured using a Visual Analog Scale) (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01623843, which also lists 20 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2020; AzTrials last refreshed its copy on 30 Oct 2026.

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