Femoroacetabular ImpingementNCT01621360
Hip Arthroscopy Versus Conservative Management of Femoroacetabular Impingement
A study testing Arthroscopic hip surgery and Physical therapy in people with Femoroacetabular Impingement, run by University of Western Ontario, Canada at 1 site in Canada.
Trial summary
The objective of this study is to determine if patients with femoroacetabular impingement (FAI) who undergo arthroscopic hip surgery experience similar outcomes at 2 years post-operative with respect to physical function, pain, and health related quality of life, compared to similar patients who receive conservative… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Femoroacetabular Impingement
- What is being tested?
- Arthroscopic hip surgery and Physical therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteCanada
- Study dates
- May 2011to May 2014
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients with femoroacetabular impingement of the hip
- 18 years of age or older
- grade 1, 2 or 3 radiographic severity of osteoarthritis as defined by the Tonnis classification scale.
Who cannot join
- identified isolated labral tear
- inflammatory or post-infectious arthritis
- previous arthroscopic treatment for hip osteoarthritis
- previous major hip trauma
- Tönnis grade 4 osteoarthritis in two compartments in persons over 60 years of age.
- patients with a major neurologic deficit, serious medical illness (life expectancy less than 2 years or high intraoperative risk) or those who are unable to provide informed consent or who are deemed unlikely to comply with follow-up.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
London Health Sciences Center, University Hospital
London, Ontario, N6G 2K3
About this study
Official title: A Randomized Controlled Trial Comparing Arthroscopic Surgery to Conservative Management of Femoroacetabular Impingement
The objective of this study is to determine if patients with femoroacetabular impingement (FAI) who undergo arthroscopic hip surgery experience similar outcomes at 2 years post-operative with respect to physical function, pain, and health related quality of life, compared to similar patients who receive conservative management, including medication and physiotherapy.
Read the detailed description
Arthroscopic surgery is now commonly used to treat patients with femoroacetabular impingement (FAI) however there is a lack of scientific evidence to support its efficacy. Two distinct types of FAI have been defined: cam impingement and pincer impingement. Cam impingement is described as an abnormally prominent anterolateral femoral head-neck junction that rubs against the acetabular rim during flexion resulting in impingement of the acetabular labrum. Pincer impingement is described as an anatomical overcoverage of the femoral head by the acetabulum that impinges the labrum leading to proliferation, or an increase in the prominence of the acetabular rim, further exacerbating the impingement. Previous studies investigating the efficacy of arthroscopic surgery of the knee and shoulder have shown no benefit compared to sham surgery and non-surgical management, therefore strong scientific evidence is needed to support its use in the treatment of hip pathology.
- Conditions
- Femoroacetabular Impingement
- Being tested
- Arthroscopic hip surgery, Physical therapy
- Keywords
- Randomized controlled trial, Intention to treat
- 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 hip surgeryProcedure or surgery
Hip arthroscopy
Physical therapyOther
Physical therapy aimed at strengthening and stabilization of the hip and appropriate analgesic and anti-inflammatory medication.
| Study group | Role | What they receive |
|---|---|---|
| Arthroscopic surgery | Active comparator | Arthroscopic surgery of the hip plus optimized medical management Receives: Procedure: Arthroscopic hip surgery |
| Conservative management | Active comparator | Physical therapy aimed at strengthening and stabilization of the hip and appropriate analgesic and anti-inflammatory medication. Receives: Other: Physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hip Outcome Score (HOS)
The HOS is a disease-specific questionnaire with high reliability and internal consistency. The index has 2 subscales: Activities of Daily Living (ADL) and Sports. Items are scored from 0-4, or N/A which removes item from scoring. The highest potential score is the total number of items with a response multiplied by 4. The item score divided by the highest potential score, multiplied by 100, generates a percentage. A higher score represents a higher level of physical function. The minimal clinically important difference is 9 points for the ADL subscale and 6 points for the Sports subscale.
Measured: 24 months
Secondary outcomes (4)
Non-Arthritic Hip Score
The Non-Arthritic Hip Score (NAHS) is a validated disease-specific questionnaire, consisting of 20 questions, divided into four domains: Pain, Symptoms, Physical Function, and Participation. Items are scored from 0-4, and added together for an overall total score. A higher score represents a higher level of physical function and less pain and symptoms. The NAHS has demonstrated good validity and has high internal consistency.
Measured: 2 weeks, and at months 3, 6, 12, 18, and 24.
Modified Harris Hip Score
The Modified Harris Hip Score is a modification of the Harris Hip Score which was originally developed for use in total hip arthroplasty patients. The modified version includes only the pain and function domains (range of motion and deformity domains from original version are removed) for a total score out of 100 points, with a higher score indicating greater function and less pain.
Measured: 2 weeks, and at months 3, 6, 12, 18, and 24.
SF-12
The SF-12 is a 12-item generic general health instrument that evaluates eight domains including restrictions or limitations on physical and social activities, normal activities and responsibilities of daily living, pain, mental health and well-being, and perceptions of health. The SF-12 has been extensively used, and has been shown to be valid, reliable, and responsive in a wide variety of populations and contexts including patients with orthopedic conditions. It is generally accepted that the minimally important difference for the SF-12 ranges from 3-5 points.
Measured: 2 weeks, and at months 3, 6, 12, 18, and 24.
Range of Motion
Measured: 2 weeks, and at months 3, 6, 12, 18, and 24.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2012 (estimated)
- Study startMay 2011
- Primary completionMay 2014 (estimated)
- Study completionMay 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Femoroacetabular ImpingementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Western Ontario, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Douglas Naudie, MD, FRCSC, Principal investigator, Western University, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01621360
- Sponsor's protocol ID
- FKSMC-2011-01
- Status last verified
- Feb 2013
- First submitted
- 19 Dec 2011
- Last updated
- 8 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Moseley JB, O'Malley K, Petersen NJ, Menke TJ, Brody BA, Kuykendall DH, Hollingsworth JC, Ashton CM, Wray NP. A controlled trial of arthroscopic surgery for osteoarthritis of the knee. N Engl J Med. 2002 Jul 11;347(2):81-8. doi: 10.1056/NEJMoa013259.
PubMed 12110735Kirkley A, Birmingham TB, Litchfield RB, Giffin JR, Willits KR, Wong CJ, Feagan BG, Donner A, Griffin SH, D'Ascanio LM, Pope JE, Fowler PJ. A randomized trial of arthroscopic surgery for osteoarthritis of the knee. N Engl J Med. 2008 Sep 11;359(11):1097-107. doi: 10.1056/NEJMoa0708333.
PubMed 18784099Neer CS 2nd. Anterior acromioplasty for the chronic impingement syndrome in the shoulder: a preliminary report. J Bone Joint Surg Am. 1972 Jan;54(1):41-50. No abstract available.
PubMed 5054450Liotard JP, Cochard P, Walch G. Critical analysis of the supraspinatus outlet view: rationale for a standard scapular Y-view. J Shoulder Elbow Surg. 1998 Mar-Apr;7(2):134-9. doi: 10.1016/s1058-2746(98)90223-3.
PubMed 9593091Gerber C, Terrier F, Ganz R. The role of the coracoid process in the chronic impingement syndrome. J Bone Joint Surg Br. 1985 Nov;67(5):703-8. doi: 10.1302/0301-620X.67B5.4055864.
PubMed 4055864Anderson K, Bowen MK. Spur reformation after arthroscopic acromioplasty. Arthroscopy. 1999 Oct;15(7):788-91. doi: 10.1016/s0749-8063(99)70018-6.
PubMed 10524832Thompson WO, Debski RE, Boardman ND 3rd, Taskiran E, Warner JJ, Fu FH, Woo SL. A biomechanical analysis of rotator cuff deficiency in a cadaveric model. Am J Sports Med. 1996 May-Jun;24(3):286-92. doi: 10.1177/036354659602400307.
PubMed 8734877Wuelker N, Plitz W, Roetman B, Wirth CJ. Function of the supraspinatus muscle. Abduction of the humerus studied in cadavers. Acta Orthop Scand. 1994 Aug;65(4):442-6. doi: 10.3109/17453679408995490.
PubMed 7976295Gosvig KK, Jacobsen S, Sonne-Holm S, Gebuhr P. The prevalence of cam-type deformity of the hip joint: a survey of 4151 subjects of the Copenhagen Osteoarthritis Study. Acta Radiol. 2008 May;49(4):436-41. doi: 10.1080/02841850801935567.
PubMed 18415788Kassarjian A, Yoon LS, Belzile E, Connolly SA, Millis MB, Palmer WE. Triad of MR arthrographic findings in patients with cam-type femoroacetabular impingement. Radiology. 2005 Aug;236(2):588-92. doi: 10.1148/radiol.2362041987. Epub 2005 Jun 21.
PubMed 15972331Martin RL, Sekiya JK. The interrater reliability of 4 clinical tests used to assess individuals with musculoskeletal hip pain. J Orthop Sports Phys Ther. 2008 Feb;38(2):71-7. doi: 10.2519/jospt.2008.2677. Epub 2007 Sep 21.
PubMed 18560194Notzli 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 12043778Pfirrmann CW, Mengiardi B, Dora C, Kalberer F, Zanetti M, Hodler J. Cam and pincer femoroacetabular impingement: characteristic MR arthrographic findings in 50 patients. Radiology. 2006 Sep;240(3):778-85. doi: 10.1148/radiol.2403050767. Epub 2006 Jul 20.
PubMed 16857978Peters CL, Erickson JA. Treatment of femoro-acetabular impingement with surgical dislocation and debridement in young adults. J Bone Joint Surg Am. 2006 Aug;88(8):1735-41. doi: 10.2106/JBJS.E.00514.
PubMed 16882895Reynolds D, Lucas J, Klaue K. Retroversion of the acetabulum. A cause of hip pain. J Bone Joint Surg Br. 1999 Mar;81(2):281-8. doi: 10.1302/0301-620x.81b2.8291.
PubMed 10204935
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing Arthroscopic Surgery to Conservative Management of Femoroacetabular Impingement
- ClinicalTrials.gov ID
- NCT01621360
- Acronym / sponsor ID
- FKSMC-2011-01
- Conditions
- Femoroacetabular Impingement
- Keywords
- Randomized controlled trial, Intention to treat
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- University of Western Ontario, CanadaUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- May 2014 (estimated)
- Study completion
- May 2014 (estimated)
- First posted
- 18 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to determine if patients with femoroacetabular impingement (FAI) who undergo arthroscopic hip surgery experience similar outcomes at 2 years post-operative with respect to physical function, pain, and health related quality of life, compared to similar patients who receive conservative management, including medication and physiotherapy.
Detailed description
Arthroscopic surgery is now commonly used to treat patients with femoroacetabular impingement (FAI) however there is a lack of scientific evidence to support its efficacy. Two distinct types of FAI have been defined: cam impingement and pincer impingement. Cam impingement is described as an abnormally prominent anterolateral femoral head-neck junction that rubs against the acetabular rim during flexion resulting in impingement of the acetabular labrum. Pincer impingement is described as an anatomical overcoverage of the femoral head by the acetabulum that impinges the labrum leading to proliferation, or an increase in the prominence of the acetabular rim, further exacerbating the impingement. Previous studies investigating the efficacy of arthroscopic surgery of the knee and shoulder have shown no benefit compared to sham surgery and non-surgical management, therefore strong scientific evidence is needed to support its use in the treatment of hip pathology.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arthroscopic surgery | Active comparator | Procedure: Arthroscopic hip surgeryArthroscopic surgery of the hip plus optimized medical management |
| Conservative management | Active comparator | Other: Physical therapyPhysical therapy aimed at strengthening and stabilization of the hip and appropriate analgesic and anti-inflammatory medication. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- patients with femoroacetabular impingement of the hip
- 18 years of age or older
- grade 1, 2 or 3 radiographic severity of osteoarthritis as defined by the Tonnis classification scale.
Key exclusion criteria (6 listed)
- identified isolated labral tear
- inflammatory or post-infectious arthritis
- previous arthroscopic treatment for hip osteoarthritis
- previous major hip trauma
- Tönnis grade 4 osteoarthritis in two compartments in persons over 60 years of age.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arthroscopic hip surgeryHip arthroscopy | Procedure or surgery | Arthroscopic surgery |
| Physical therapyPhysical therapy aimed at strengthening and stabilization of the hip and appropriate analgesic and anti-inflammatory medication. | Other | Conservative management |
Primary outcome
Hip Outcome Score (HOS)
Time frame: 24 months
The HOS is a disease-specific questionnaire with high reliability and internal consistency. The index has 2 subscales: Activities of Daily Living (ADL) and Sports. Items are scored from 0-4, or N/A which removes item from scoring. The highest potential score is the total number of items with a response multiplied by 4. The item score divided by the highest potential score, multiplied by 100, generates a percentage. A higher score represents a higher level of physical function. The minimal clinically important difference is 9 points for the ADL subscale and 6 points for the Sports subscale.
4 secondary outcomes
Non-Arthritic Hip Score
Time frame: 2 weeks, and at months 3, 6, 12, 18, and 24.
Modified Harris Hip Score
Time frame: 2 weeks, and at months 3, 6, 12, 18, and 24.
SF-12
Time frame: 2 weeks, and at months 3, 6, 12, 18, and 24.
Range of Motion
Time frame: 2 weeks, and at months 3, 6, 12, 18, and 24.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2013.
- Background: PubMed 12110735Moseley JB, O'Malley K, Petersen NJ, Menke TJ, Brody BA, Kuykendall DH, Hollingsworth JC, Ashton CM, Wray NP. A controlled trial of arthroscopic surgery for osteoarthritis of the knee. N Engl J Med. 2002 Jul 11;347(2):81-8. doi: 10.1056/NEJMoa013259.
- Background: PubMed 18784099Kirkley A, Birmingham TB, Litchfield RB, Giffin JR, Willits KR, Wong CJ, Feagan BG, Donner A, Griffin SH, D'Ascanio LM, Pope JE, Fowler PJ. A randomized trial of arthroscopic surgery for osteoarthritis of the knee. N Engl J Med. 2008 Sep 11;359(11):1097-107. doi: 10.1056/NEJMoa0708333.
- Background: PubMed 5054450Neer CS 2nd. Anterior acromioplasty for the chronic impingement syndrome in the shoulder: a preliminary report. J Bone Joint Surg Am. 1972 Jan;54(1):41-50. No abstract available.
- Background: PubMed 9593091Liotard JP, Cochard P, Walch G. Critical analysis of the supraspinatus outlet view: rationale for a standard scapular Y-view. J Shoulder Elbow Surg. 1998 Mar-Apr;7(2):134-9. doi: 10.1016/s1058-2746(98)90223-3.
- Background: PubMed 4055864Gerber C, Terrier F, Ganz R. The role of the coracoid process in the chronic impingement syndrome. J Bone Joint Surg Br. 1985 Nov;67(5):703-8. doi: 10.1302/0301-620X.67B5.4055864.
- Background: PubMed 10524832Anderson K, Bowen MK. Spur reformation after arthroscopic acromioplasty. Arthroscopy. 1999 Oct;15(7):788-91. doi: 10.1016/s0749-8063(99)70018-6.
- Background: PubMed 8734877Thompson WO, Debski RE, Boardman ND 3rd, Taskiran E, Warner JJ, Fu FH, Woo SL. A biomechanical analysis of rotator cuff deficiency in a cadaveric model. Am J Sports Med. 1996 May-Jun;24(3):286-92. doi: 10.1177/036354659602400307.
- Background: PubMed 7976295Wuelker N, Plitz W, Roetman B, Wirth CJ. Function of the supraspinatus muscle. Abduction of the humerus studied in cadavers. Acta Orthop Scand. 1994 Aug;65(4):442-6. doi: 10.3109/17453679408995490.
- Background: PubMed 18415788Gosvig KK, Jacobsen S, Sonne-Holm S, Gebuhr P. The prevalence of cam-type deformity of the hip joint: a survey of 4151 subjects of the Copenhagen Osteoarthritis Study. Acta Radiol. 2008 May;49(4):436-41. doi: 10.1080/02841850801935567.
- Background: PubMed 15972331Kassarjian A, Yoon LS, Belzile E, Connolly SA, Millis MB, Palmer WE. Triad of MR arthrographic findings in patients with cam-type femoroacetabular impingement. Radiology. 2005 Aug;236(2):588-92. doi: 10.1148/radiol.2362041987. Epub 2005 Jun 21.
- Background: PubMed 18560194Martin RL, Sekiya JK. The interrater reliability of 4 clinical tests used to assess individuals with musculoskeletal hip pain. J Orthop Sports Phys Ther. 2008 Feb;38(2):71-7. doi: 10.2519/jospt.2008.2677. Epub 2007 Sep 21.
- Background: PubMed 12043778Notzli 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Douglas Naudie, MD, FRCSC principal investigator
Western University, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arthroscopic hip surgery and Physical therapy in people with Femoroacetabular Impingement, run by University of Western Ontario, Canada at 1 site in Canada.
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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 8 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stacey Wanlin (519-661-2111 ext. 80946, swanlin@uwo.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hip Outcome Score (HOS) (time frame: 24 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 NCT01621360, which also lists 16 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 8 Feb 2013.