NCT03949127

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
95

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 14, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 14, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

September 6, 2019

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 4, 2023

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

January 5, 2024

Status Verified

January 1, 2024

Enrollment Period

3.8 years

First QC Date

April 14, 2019

Last Update Submit

January 2, 2024

Conditions

Keywords

non-surgical treatmentexercise

Outcome Measures

Primary Outcomes (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.

    Change in Baseline before exercise program and 6 months

Secondary Outcomes (3)

  • EQ-5D-5L

    Change in Baseline before exercise program and 6 months afterward

  • Number of participants that receive hip surgery

    Change in Baseline before exercise program and 1 year afterwards

  • Patient-reported hip pain

    Change in Baseline before exercise program and 6 months

Study Arms (2)

Exercise Group

EXPERIMENTAL

The group who will exercise to manage pain.

Other: Exercise Group

Control Group

NO INTERVENTION

The group who will not take part in any exercises and only have to do assessments.

Interventions

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

Exercise Group

Eligibility Criteria

Age16 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

Location

Related Publications (27)

  • 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.

    PMID: 27011797BACKGROUND
  • 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.

    PMID: 24481825BACKGROUND
  • 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.

    PMID: 25246442BACKGROUND
  • 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.

    PMID: 20962194BACKGROUND
  • 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.

    PMID: 25842248BACKGROUND
  • 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.

    PMID: 25913231BACKGROUND
  • 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.

    PMID: 23357224BACKGROUND
  • 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.

    PMID: 28259463BACKGROUND
  • 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.

    PMID: 23604603BACKGROUND
  • 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.

    PMID: 29632694BACKGROUND
  • 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.

    PMID: 24115571BACKGROUND
  • 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.

    PMID: 26573964BACKGROUND
  • 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.

    PMID: 28816897BACKGROUND
  • 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.

    PMID: 27107630BACKGROUND
  • 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.

    PMID: 23419746BACKGROUND
  • Lamontagne M, Kennedy MJ, Beaule PE. The effect of cam FAI on hip and pelvic motion during maximum squat. Clin Orthop Relat Res. 2009 Mar;467(3):645-50. doi: 10.1007/s11999-008-0620-x. Epub 2008 Nov 26.

    PMID: 19034598BACKGROUND
  • Seijas R, Alentorn-Geli E, Alvarez-Diaz P, Marin M, Ares O, Sallent A, Cusco X, Cugat R. Gluteus maximus impairment in femoroacetabular impingement: a tensiomyographic evaluation of a clinical fact. Arch Orthop Trauma Surg. 2016 Jun;136(6):785-9. doi: 10.1007/s00402-016-2428-6. Epub 2016 Feb 25.

    PMID: 26914331BACKGROUND
  • Ross JR, Nepple JJ, Philippon MJ, Kelly BT, Larson CM, Bedi A. Effect of changes in pelvic tilt on range of motion to impingement and radiographic parameters of acetabular morphologic characteristics. Am J Sports Med. 2014 Oct;42(10):2402-9. doi: 10.1177/0363546514541229. Epub 2014 Jul 24.

    PMID: 25060073BACKGROUND
  • Nepple JJ, Prather H, Trousdale RT, Clohisy JC, Beaule PE, Glyn-Jones S, Kim YJ. Clinical diagnosis of femoroacetabular impingement. J Am Acad Orthop Surg. 2013;21 Suppl 1:S16-9. doi: 10.5435/JAAOS-21-07-S16.

    PMID: 23818186BACKGROUND
  • Nwachukwu BU, Fields K, Chang B, Nawabi DH, Kelly BT, Ranawat AS. Preoperative Outcome Scores Are Predictive of Achieving the Minimal Clinically Important Difference After Arthroscopic Treatment of Femoroacetabular Impingement. Am J Sports Med. 2017 Mar;45(3):612-619. doi: 10.1177/0363546516669325. Epub 2016 Oct 23.

    PMID: 27765733BACKGROUND
  • Wright AA, Hegedus EJ, Taylor JB, Dischiavi SL, Stubbs AJ. Non-operative management of femoroacetabular impingement: A prospective, randomized controlled clinical trial pilot study. J Sci Med Sport. 2016 Sep;19(9):716-21. doi: 10.1016/j.jsams.2015.11.008. Epub 2016 Jan 6.

    PMID: 26795448BACKGROUND
  • Coppack RJ, Bilzon JL, Wills AK, McCurdie IM, Partridge LK, Nicol AM, Bennett AN. Physical and functional outcomes following multidisciplinary residential rehabilitation for prearthritic hip pain among young active UK military personnel. BMJ Open Sport Exerc Med. 2016 Apr 1;2(1):e000107. doi: 10.1136/bmjsem-2015-000107. eCollection 2016.

    PMID: 27900174BACKGROUND
  • Griffin D, Wall P, Realpe A, Adams A, Parsons N, Hobson R, Achten J, Fry J, Costa M, Petrou S, Foster N, Donovan J. UK FASHIoN: feasibility study of a randomised controlled trial of arthroscopic surgery for hip impingement compared with best conservative care. Health Technol Assess. 2016 Apr;20(32):1-172. doi: 10.3310/hta20320.

    PMID: 27117505BACKGROUND
  • Crawford MJ, Dy CJ, Alexander JW, Thompson M, Schroder SJ, Vega CE, Patel RV, Miller AR, McCarthy JC, Lowe WR, Noble PC. The 2007 Frank Stinchfield Award. The biomechanics of the hip labrum and the stability of the hip. Clin Orthop Relat Res. 2007 Dec;465:16-22. doi: 10.1097/BLO.0b013e31815b181f.

    PMID: 17906586BACKGROUND
  • Kapron AL, Aoki SK, Peters CL, Anderson AE. Subject-specific patterns of femur-labrum contact are complex and vary in asymptomatic hips and hips with femoroacetabular impingement. Clin Orthop Relat Res. 2014 Dec;472(12):3912-22. doi: 10.1007/s11999-014-3919-9. Epub 2014 Sep 6.

    PMID: 25193693BACKGROUND
  • Savic D, Pedoia V, Seo Y, Yang J, Bucknor M, Franc BL, Majumdar S. Imaging Bone-Cartilage Interactions in Osteoarthritis Using [18F]-NaF PET-MRI. Mol Imaging. 2016 Jan 1;15:1-12. doi: 10.1177/1536012116683597.

    PMID: 28654417BACKGROUND
  • Pierannunzii L. Pelvic posture and kinematics in femoroacetabular impingement: a systematic review. J Orthop Traumatol. 2017 Sep;18(3):187-196. doi: 10.1007/s10195-016-0439-2. Epub 2017 Feb 1.

    PMID: 28150180BACKGROUND

MeSH Terms

Conditions

Femoracetabular ImpingementMotor Activity

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Paul Beaule, MD, FRCSC

    Ottawa Hospital Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: There will be two groups, one will be the exercise group and one will be used as a control group.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2019

First Posted

May 14, 2019

Study Start

September 6, 2019

Primary Completion

July 4, 2023

Study Completion

April 1, 2024

Last Updated

January 5, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations