AzTrials
AzTrials

Femoracetabular ImpingementNCT03949127

Efficacy of an Exercise Program for Patients With Femoro-acetabular Impingement

A study testing Exercise Group in people with Femoracetabular Impingement, run by Ottawa Hospital Research Institute at 1 site in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

The purpose of this study is to examine whether using an exercise regime on people with femoroacetabular impingement (FAI) can help reduce pain and improve function. Also, it examines whether the exercise regime will help prevent the worsening of hip cartilage deterioration. Read more about this study

Who is it for?
Ages 16 to 50 years
Conditions the study is for
Femoracetabular Impingement
What is being tested?
Exercise Group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
95 participants
Where
1 siteCanada
Study dates
6 Sep 2019to Apr 2024
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 16 to 50 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Diagnosed with symptomatic FAI
  • at least 3 months of groin pain
  • increased pain with hip rotation
  • an alpha angle greater than 60 degrees on multiplane imaging
  • labral tear on MRI
  • Tonnis grade of 0 or 1

Who cannot join

  • diagnosed health problems other than FAI interfering with capacity to accomplish the exercise program
  • previous hip surgery on the affected side
  • surgery will happen within 6 months

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • The Ottawa Hospital

    Ottawa, Ontario, K1H 8L6

Other trials in Canada

About this study

Official title: Efficacy of a Non-surgical Treatment Protocol for Patients With Symptomatic Femoro-acetabular Impingement: a Randomized Controlled Trial

The purpose of this study is to examine whether using an exercise regime on people with femoroacetabular impingement (FAI) can help reduce pain and improve function. Also, it examines whether the exercise regime will help prevent the worsening of hip cartilage deterioration.

Read the detailed description

A significant proportion of adults from ages 18 to 50 have a deformity in the neck of their femur. This can be painful and is called a femoroacetabular impingement (FAI), and could lead to ones cartilage being destroyed and possibly lead to osteoarthritis of the hip. People with this deformity in their femur have been found to move their hips differently when doing tasks such as walking, squatting or climbing stairs compared to those without this problem. The investigators are testing whether exercise that targets this difference in movement can help reduce pain, improve function and prevent cartilage damage. There will recruit 84 patients with divided into 2 groups. 42 patients will do a 8 week exercise program on strengthening muscles responsible for extending the hip and stretching muscles that are associated with flexing the hip. The intensity of the program will change with visits to the physiotherapist through the course of their exercise program. This research hopes to develop an innovative, non-surgical, low-cost, highly feasible and accessible intervention for patients with FAI.

Being tested
Exercise Group
Keywords
non-surgical treatment, exercise
Medical subject headings
Femoracetabular Impingement, Motor Activity

What participants receive

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

  • Exercise GroupOther

    The group who will meet a physiotherapist who will show them strengthening and stretching muscles associated with pelvic tilt.

Study groups in NCT03949127
Study groupRoleWhat they receive
Exercise GroupExperimentalThe group who will exercise to manage pain.
Receives: Other: Exercise Group
Control GroupNo interventionThe group who will not take part in any exercises and only have to do assessments.

What is being measured

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

  1. iHOT-33

    International Hip Outcome Tool-33, disease-specific function. Each answer will be measured on a scale of 100mm and the mean of the 33 questions will be taken as a final score. A higher score indicates a better quality of life.

    Measured: Change in Baseline before exercise program and 6 months

Secondary outcomes (3)

  1. EQ-5D-5L

    Generic quality of life, the scores for each question are summed up for a total with a higher score being a better quality of life.

    Measured: Change in Baseline before exercise program and 6 months afterward

  2. Number of participants that receive hip surgery

    If the participant has hip surgery in the time frame

    Measured: Change in Baseline before exercise program and 1 year afterwards

  3. Patient-reported hip pain

    Patient perceived pain on a VAS scale

    Measured: Change in Baseline before exercise program and 6 months

Timeline

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

  1. First posted14 May 2019
  2. Study start6 Sep 2019
  3. Primary completion4 Jul 2023
  4. Study completionApr 2024 (estimated)

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
Model description
There will be two groups, one will be the exercise group and one will be used as a control group.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
95 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03949127
Sponsor's protocol ID
20190091
Status last verified
Jan 2024
First submitted
14 Apr 2019
Last updated
5 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Khanna V, Beaule PE. Defining structural abnormalities of the hip joint at risk of degeneration. J Hip Preserv Surg. 2014 Sep 6;1(1):12-20. doi: 10.1093/jhps/hnu004. eCollection 2014 Jul.

    PubMed 27011797

  • Khanna V, Caragianis A, Diprimio G, Rakhra K, Beaule PE. Incidence of hip pain in a prospective cohort of asymptomatic volunteers: is the cam deformity a risk factor for hip pain? Am J Sports Med. 2014 Apr;42(4):793-7. doi: 10.1177/0363546513518417. Epub 2014 Jan 30.

    PubMed 24481825

  • Diamond LE, Dobson FL, Bennell KL, Wrigley TV, Hodges PW, Hinman RS. Physical impairments and activity limitations in people with femoroacetabular impingement: a systematic review. Br J Sports Med. 2015 Feb;49(4):230-42. doi: 10.1136/bjsports-2013-093340. Epub 2014 Sep 22.

    PubMed 25246442

  • Hack K, Di Primio G, Rakhra K, Beaule PE. Prevalence of cam-type femoroacetabular impingement morphology in asymptomatic volunteers. J Bone Joint Surg Am. 2010 Oct 20;92(14):2436-44. doi: 10.2106/JBJS.J.01280.

    PubMed 20962194

  • Peters CL. Mild to Moderate Hip OA: Joint Preservation or Total Hip Arthroplasty? J Arthroplasty. 2015 Jul;30(7):1109-12. doi: 10.1016/j.arth.2015.02.046. Epub 2015 Mar 25.

    PubMed 25842248

  • Beaule PE, Singh A, Poitras S, Parker G. Surgical Dislocation of the Hip for the Treatment of Pre-Arthritic Hip Disease. J Arthroplasty. 2015 Sep;30(9):1502-5. doi: 10.1016/j.arth.2015.04.009. Epub 2015 Apr 11.

    PubMed 25913231

  • Speirs AD, Beaule PE, Rakhra KS, Schweitzer ME, Frei H. Increased acetabular subchondral bone density is associated with cam-type femoroacetabular impingement. Osteoarthritis Cartilage. 2013 Apr;21(4):551-8. doi: 10.1016/j.joca.2013.01.012. Epub 2013 Jan 26.

    PubMed 23357224

  • Speirs AD, Beaule PE, Huang A, Frei H. Properties of the cartilage layer from the cam-type hip impingement deformity. J Biomech. 2017 Apr 11;55:78-84. doi: 10.1016/j.jbiomech.2017.02.007. Epub 2017 Feb 21.

    PubMed 28259463

  • Carsen S, Moroz PJ, Rakhra K, Ward LM, Dunlap H, Hay JA, Willis RB, Beaule PE. The Otto Aufranc Award. On the etiology of the cam deformity: a cross-sectional pediatric MRI study. Clin Orthop Relat Res. 2014 Feb;472(2):430-6. doi: 10.1007/s11999-013-2990-y.

    PubMed 23604603

  • Gala L, Khanna V, Rakhra KS, Beaule PE. Does the femoral head/neck contour in the skeletally mature change over time? J Hip Preserv Surg. 2016 Aug 3;3(4):333-337. doi: 10.1093/jhps/hnw022. eCollection 2016 Oct.

    PubMed 29632694

  • Li X, Majumdar S. Quantitative MRI of articular cartilage and its clinical applications. J Magn Reson Imaging. 2013 Nov;38(5):991-1008. doi: 10.1002/jmri.24313. Epub 2013 Oct 2.

    PubMed 24115571

  • Anwander H, Melkus G, Rakhra KS, Beaule PE. T1rho MRI detects cartilage damage in asymptomatic individuals with a cam deformity. J Orthop Res. 2016 Jun;34(6):1004-9. doi: 10.1002/jor.23101. Epub 2015 Dec 2.

    PubMed 26573964

  • Beaule PE, Speirs AD, Anwander H, Melkus G, Rakhra K, Frei H, Lamontagne M. Surgical Correction of Cam Deformity in Association with Femoroacetabular Impingement and Its Impact on the Degenerative Process within the Hip Joint. J Bone Joint Surg Am. 2017 Aug 16;99(16):1373-1381. doi: 10.2106/JBJS.16.00415.

    PubMed 28816897

  • Fairley J, Wang Y, Teichtahl AJ, Seneviwickrama M, Wluka AE, Brady SRE, Hussain SM, Liew S, Cicuttini FM. Management options for femoroacetabular impingement: a systematic review of symptom and structural outcomes. Osteoarthritis Cartilage. 2016 Oct;24(10):1682-1696. doi: 10.1016/j.joca.2016.04.014. Epub 2016 Apr 20.

    PubMed 27107630

  • Wall PD, Fernandez M, Griffin DR, Foster NE. Nonoperative treatment for femoroacetabular impingement: a systematic review of the literature. PM R. 2013 May;5(5):418-26. doi: 10.1016/j.pmrj.2013.02.005. Epub 2013 Feb 16.

    PubMed 23419746

Questions about this trial

What is this clinical trial studying?

A study testing Exercise Group in people with Femoracetabular Impingement, run by Ottawa Hospital Research Institute 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 6 inclusion and 3 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 5 Jan 2024. 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?

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?

iHOT-33 (time frame: Change in Baseline before exercise program and 6 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 NCT03949127, which also lists 27 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 5 Jan 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in