Early Versus Delayed Weightbearing in Femoroacetabular Impingement Syndrome Patients

NCT05256628 | Unknown DMC

• 1 other identifier: 2020-0154-B
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

Femoroacetabular impingement syndrome (FAIS) is a condition caused by an abnormal bone structure that causes the bones on either side of the hip joint to impinge on each other during certain movements, thus causing pain. This condition can be surgically treated with hip arthroscopy. For patients undergoing hip arthroscopy, there are currently two protocols related to how they may bear their weight after surgery: 1) Delayed Weightbearing: Patients use crutches and put very little weight on the surgical side. After 6 weeks, they are able to bear weight, 2) Immediate Weightbearing: Patients bear weight on the affected side, as tolerated, immediately after surgery with crutches for additional support. They are then permitted to stop using the crutches in the weeks after surgery as they feel comfortable and are stable on the operative leg. The purpose of this study is to determine whether immediate or delayed weightbearing protocols following hip arthroscopy impact patient outcomes and complication rates. Participants will be randomly allocated into one of the two aforementioned groups, and followed up for 2 years to assess function and patient-reported outcomes.

Conditions

Femoroacetabular Impingement Syndrome

Keywords

Femoroacetabular Impingement; Femoroacetabular Impingement Syndrome; FAI; Hip Arthroscopy; Osteochondroplasty; Orthopaedics; Sports Medicine; Hip; Weight Bearing; Surgery; Arthroscopy

Outcome Measures

Primary Outcomes (1)

• International Hip Outcome Tool (iHOT-33)

  The primary outcome is the difference between the two interventions in their iHOT-33 scores at 1 year post-surgery. The iHOT-33 questionnaire consists of 33 questions evaluating hip symptoms, functional impairments, sporting activities, job concerns, as well as social and emotional wellbeing. Participants will rate their pain and impairment levels on a scale of 0 to 10, 0 being severe pain/impairment, and 10 being no pain or trouble at all.

  Administered at baseline, 6 months, 1 year, and 2 years post-operatively

Secondary Outcomes (4)

• Hip Outcome Score, Activities of Daily Living (HOS-ADL)

  Administered at baseline, 6 months, 1 year, and 2 years post-operatively

• European Quality of Life Five Dimension Five Level (EQ-5D-5L)

  Administered at baseline, 6 months, 1 year, and 2 years post-operatively

• Pain Visual Analog Scale (VAS)

  Administered at baseline, 2 weeks, 6 weeks, 3 months, 6 months, 1 year, and 2 years post-operatively

• Post-Operative Complications

  Recorded at 2 weeks, 6 weeks, 3 months, 6 months, 1 year, and 2 years post-operatively.

Study Arms (2)

Early Weightbearing

OTHER

Patients randomized to early weightbearing will be permitted to begin immediate postoperative weightbearing as tolerated with crutches for additional stability.

Other: Early Weightbearing

Protected Weightbearing

OTHER

Patients in the protected weightbearing group will be instructed to be touch weightbearing for a period of 6-weeks postoperatively before commencing to be weightbearing as tolerated.

Other: Protected Weightbearing

Interventions

Early Weightbearing OTHER

Patients randomized to undergo this study intervention will bear weight, as tolerated, on the affected side straight after surgery, with crutches for additional support and stability. They will be allowed to stop using crutches in the weeks after surgery as they feel more comfortable and stable on their surgical leg.

Early Weightbearing

Protected Weightbearing OTHER

Patients randomized to undergo this study intervention will be instructed to be touch weightbearing for 6 weeks after surgery. They will use crutches and put no more weight on the surgical side than what it takes to crack an egg. After the 6-week mark, they will be able to bear weight.

Protected Weightbearing

Eligibility Criteria

• Age: 16 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Diagnosis of femoroacetabular impingement syndrome (FAIS)
• Booked for hip arthroscopy surgery and osteochondroplasty for FAIS at a participating site
• English literate

You may not qualify if:

• Prior hip surgery, arthroscopic or otherwise
• Workplace Safety and Insurance Board/medicolegal claim, complex regional pain syndrome, fibromyalgia, pain syndrome diagnoses, regular opioid use beyond 50mg morphine equivalents per day
• Hip dysplasia, Legg-Calve-Perthes disease or slipped capital femoral epiphysis, Arthritis \> Tonnis 1
• Chondral matrix repair, microfracture/osteoarticular transfer system (OATS)

Sponsors & Collaborators

• Women's College Hospital: lead
• University of Toronto Orthopaedic Sports Medicine: collaborator

Study Sites (1)

Women's College Hospital

Toronto, Ontario, M5S 1B2, Canada

Location

Related Publications (40)

• Colvin AC, Harrast J, Harner C. Trends in hip arthroscopy. J Bone Joint Surg Am. 2012 Feb 15;94(4):e23. doi: 10.2106/JBJS.J.01886.

  PMID: 22336982 BACKGROUND

• Bozic KJ, Chan V, Valone FH 3rd, Feeley BT, Vail TP. Trends in hip arthroscopy utilization in the United States. J Arthroplasty. 2013 Sep;28(8 Suppl):140-3. doi: 10.1016/j.arth.2013.02.039. Epub 2013 Aug 1.

  PMID: 23916639 BACKGROUND

• Montgomery SR, Ngo SS, Hobson T, Nguyen S, Alluri R, Wang JC, Hame SL. Trends and demographics in hip arthroscopy in the United States. Arthroscopy. 2013 Apr;29(4):661-5. doi: 10.1016/j.arthro.2012.11.005. Epub 2013 Feb 1.

  PMID: 23375668 BACKGROUND

• Ross JR, Larson CM, Bedi A. Indications for Hip Arthroscopy. Sports Health. 2017 Sep/Oct;9(5):402-413. doi: 10.1177/1941738117712675. Epub 2017 Jul 5.

  PMID: 28678628 BACKGROUND

• Ricciardi BF, Fabricant PD, Fields KG, Poultsides L, Zaltz I, Sink EL. What are the demographic and radiographic characteristics of patients with symptomatic extraarticular femoroacetabular impingement? Clin Orthop Relat Res. 2015 Apr;473(4):1299-308. doi: 10.1007/s11999-014-4001-3.

  PMID: 25344401 BACKGROUND

• Petrera M, Yanez-Siller F, Whelan D, Hoit G, Mahjoob M, Chahal J, Dwyer T. Analysis of the referral pattern and wait time for hip arthroscopy in a single payer publicly funded health care system. J Eval Clin Pract. 2020 Feb;26(1):81-85. doi: 10.1111/jep.13192. Epub 2019 May 29.

  PMID: 31144433 BACKGROUND

• Wylie JD, Peters CL, Aoki SK. Natural History of Structural Hip Abnormalities and the Potential for Hip Preservation. J Am Acad Orthop Surg. 2018 Aug 1;26(15):515-525. doi: 10.5435/JAAOS-D-16-00532.

  PMID: 29939866 BACKGROUND

• McCarthy JC, Lee JA. History of hip arthroscopy: challenges and opportunities. Clin Sports Med. 2011 Apr;30(2):217-24. doi: 10.1016/j.csm.2010.12.001.

  PMID: 21419953 BACKGROUND

• Collins JA, Ward JP, Youm T. Is prophylactic surgery for femoroacetabular impingement indicated? A systematic review. Am J Sports Med. 2014 Dec;42(12):3009-15. doi: 10.1177/0363546513499227. Epub 2013 Aug 21.

  PMID: 23966568 BACKGROUND

• 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

• Agricola R, Heijboer MP, Bierma-Zeinstra SM, Verhaar JA, Weinans H, Waarsing JH. Cam impingement causes osteoarthritis of the hip: a nationwide prospective cohort study (CHECK). Ann Rheum Dis. 2013 Jun;72(6):918-23. doi: 10.1136/annrheumdis-2012-201643. Epub 2012 Jun 23.

  PMID: 22730371 BACKGROUND

• Cvetanovich GL, Lizzio V, Meta F, Chan D, Zaltz I, Nho SJ, Makhni EC. Variability and Comprehensiveness of North American Online Available Physical Therapy Protocols Following Hip Arthroscopy for Femoroacetabular Impingement and Labral Repair. Arthroscopy. 2017 Nov;33(11):1998-2005. doi: 10.1016/j.arthro.2017.06.045. Epub 2017 Sep 29.

  PMID: 28969949 BACKGROUND

• Avnieli IB, Vidra M, Factor S, Atzmon R, Persitz J, Safran N, Rath E, Amar E. Postoperative Weightbearing Protocols After Arthroscopic Surgery for Femoroacetabular Impingement Does Not Affect Patient Outcome: A Comparative Study With Minimum 2-Year Follow-up. Arthroscopy. 2020 Jan;36(1):159-164. doi: 10.1016/j.arthro.2019.08.012.

  PMID: 31864571 BACKGROUND

• Ayeni OR, Bedi A, Lorich DG, Kelly BT. Femoral neck fracture after arthroscopic management of femoroacetabular impingement: a case report. J Bone Joint Surg Am. 2011 May 4;93(9):e47. doi: 10.2106/JBJS.J.00792. No abstract available.

  PMID: 21543668 BACKGROUND

• Weber AE, Harris JD, Nho SJ. Complications in Hip Arthroscopy: A Systematic Review and Strategies for Prevention. Sports Med Arthrosc Rev. 2015 Dec;23(4):187-93. doi: 10.1097/JSA.0000000000000084.

  PMID: 26524553 BACKGROUND

• Mardones RM, Gonzalez C, Chen Q, Zobitz M, Kaufman KR, Trousdale RT. Surgical treatment of femoroacetabular impingement: evaluation of the effect of the size of the resection. J Bone Joint Surg Am. 2005 Feb;87(2):273-9. doi: 10.2106/JBJS.D.01793.

  PMID: 15687147 BACKGROUND

• Alonso-Rasgado T, Jimenez-Cruz D, Bailey CG, Mandal P, Board T. Changes in the stress in the femoral head neck junction after osteochondroplasty for hip impingement: a finite element study. J Orthop Res. 2012 Dec;30(12):1999-2006. doi: 10.1002/jor.22164. Epub 2012 Jun 15.

  PMID: 22707347 BACKGROUND

• Suchak AA, Bostick GP, Beaupre LA, Durand DC, Jomha NM. The influence of early weight-bearing compared with non-weight-bearing after surgical repair of the Achilles tendon. J Bone Joint Surg Am. 2008 Sep;90(9):1876-83. doi: 10.2106/JBJS.G.01242.

  PMID: 18762647 BACKGROUND

• Tyler TF, McHugh MP, Gleim GW, Nicholas SJ. The effect of immediate weightbearing after anterior cruciate ligament reconstruction. Clin Orthop Relat Res. 1998 Dec;(357):141-8. doi: 10.1097/00003086-199812000-00019.

  PMID: 9917711 BACKGROUND

• Smeeing DPJ, Houwert RM, Briet JP, Groenwold RHH, Lansink KWW, Leenen LPH, van der Zwaal P, Hoogendoorn JM, van Heijl M, Verleisdonk EJ, Segers MJM, Hietbrink F. Weight-bearing or non-weight-bearing after surgical treatment of ankle fractures: a multicenter randomized controlled trial. Eur J Trauma Emerg Surg. 2020 Feb;46(1):121-130. doi: 10.1007/s00068-018-1016-6. Epub 2018 Sep 24.

  PMID: 30251154 BACKGROUND

• Andersson L, Wesslau A, Boden H, Dalen N. Immediate or late weight bearing after uncemented total hip arthroplasty: a study of functional recovery. J Arthroplasty. 2001 Dec;16(8):1063-5. doi: 10.1054/arth.2001.27253.

  PMID: 11740764 BACKGROUND

• Rath E, Sharfman ZT, Paret M, Amar E, Drexler M, Bonin N. Hip arthroscopy protocol: expert opinions on post-operative weight bearing and return to sports guidelines. J Hip Preserv Surg. 2017 Feb 23;4(1):60-66. doi: 10.1093/jhps/hnw045. eCollection 2017 Jan.

  PMID: 28630722 BACKGROUND

• Koh JL, Gupta K. Evaluation of repair of the hip labrum under simulated full weight-bearing. Hip Int. 2017 Feb 21;27(1):104-109. doi: 10.5301/hipint.5000472. Epub 2017 Jan 24.

  PMID: 28127741 BACKGROUND

• Griffin DR, Dickenson EJ, O'Donnell J, Agricola R, Awan T, Beck M, Clohisy JC, Dijkstra HP, Falvey E, Gimpel M, Hinman RS, Holmich P, Kassarjian A, Martin HD, Martin R, Mather RC, Philippon MJ, Reiman MP, Takla A, Thorborg K, Walker S, Weir A, Bennell KL. The Warwick Agreement on femoroacetabular impingement syndrome (FAI syndrome): an international consensus statement. Br J Sports Med. 2016 Oct;50(19):1169-76. doi: 10.1136/bjsports-2016-096743.

  PMID: 27629403 BACKGROUND

• Gwathmey FW, Jones KS, Thomas Byrd JW. Revision hip arthroscopy: findings and outcomes. J Hip Preserv Surg. 2017 May 11;4(4):318-323. doi: 10.1093/jhps/hnx014. eCollection 2017 Dec.

  PMID: 29250340 BACKGROUND

• Palmer S, Bailey J, Brown C, Jones A, McCabe CS. Sensory Function and Pain Experience in Arthritis, Complex Regional Pain Syndrome, Fibromyalgia Syndrome, and Pain-Free Volunteers: A Cross-Sectional Study. Clin J Pain. 2019 Nov;35(11):894-900. doi: 10.1097/AJP.0000000000000751.

  PMID: 31408010 BACKGROUND

• Murgatroyd DF, Casey PP, Cameron ID, Harris IA. The effect of financial compensation on health outcomes following musculoskeletal injury: systematic review. PLoS One. 2015 Feb 13;10(2):e0117597. doi: 10.1371/journal.pone.0117597. eCollection 2015.

  PMID: 25680118 BACKGROUND

• Nabavi A, Olwill CM, Harris IA. Preoperative predictors of outcome in the arthroscopic treatment of femoroacetabular impingement. Hip Int. 2015 Sep-Oct;25(5):402-5. doi: 10.5301/hipint.5000261. Epub 2015 May 27.

  PMID: 26044534 BACKGROUND

• Kemp JL, MacDonald D, Collins NJ, Hatton AL, Crossley KM. Hip arthroscopy in the setting of hip osteoarthritis: systematic review of outcomes and progression to hip arthroplasty. Clin Orthop Relat Res. 2015 Mar;473(3):1055-73. doi: 10.1007/s11999-014-3943-9. Epub 2014 Sep 18.

  PMID: 25231154 BACKGROUND

• Philippon MJ, Briggs KK, Carlisle JC, Patterson DC. Joint space predicts THA after hip arthroscopy in patients 50 years and older. Clin Orthop Relat Res. 2013 Aug;471(8):2492-6. doi: 10.1007/s11999-012-2779-4.

  PMID: 23292888 BACKGROUND

• Mohtadi NG, Griffin DR, Pedersen ME, Chan D, Safran MR, Parsons N, Sekiya JK, Kelly BT, Werle JR, Leunig M, McCarthy JC, Martin HD, Byrd JW, Philippon MJ, Martin RL, Guanche CA, Clohisy JC, Sampson TG, Kocher MS, Larson CM; Multicenter Arthroscopy of the Hip Outcomes Research Network. The Development and validation of a self-administered quality-of-life outcome measure for young, active patients with symptomatic hip disease: the International Hip Outcome Tool (iHOT-33). Arthroscopy. 2012 May;28(5):595-605; quiz 606-10.e1. doi: 10.1016/j.arthro.2012.03.013.

  PMID: 22542433 BACKGROUND

• Griffin DR, Parsons N, Mohtadi NG, Safran MR; Multicenter Arthroscopy of the Hip Outcomes Research Network. A short version of the International Hip Outcome Tool (iHOT-12) for use in routine clinical practice. Arthroscopy. 2012 May;28(5):611-6; quiz 616-8. doi: 10.1016/j.arthro.2012.02.027.

  PMID: 22542434 BACKGROUND

• Kemp JL, Collins NJ, Roos EM, Crossley KM. Psychometric properties of patient-reported outcome measures for hip arthroscopic surgery. Am J Sports Med. 2013 Sep;41(9):2065-73. doi: 10.1177/0363546513494173. Epub 2013 Jul 8.

  PMID: 23835268 BACKGROUND

• 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: 27117505 BACKGROUND

• Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011 Dec;20(10):1727-36. doi: 10.1007/s11136-011-9903-x. Epub 2011 Apr 9.

  PMID: 21479777 BACKGROUND

• Devlin NJ, Shah KK, Feng Y, Mulhern B, van Hout B. Valuing health-related quality of life: An EQ-5D-5L value set for England. Health Econ. 2018 Jan;27(1):7-22. doi: 10.1002/hec.3564. Epub 2017 Aug 22.

  PMID: 28833869 BACKGROUND

• Delgado DA, Lambert BS, Boutris N, McCulloch PC, Robbins AB, Moreno MR, Harris JD. Validation of Digital Visual Analog Scale Pain Scoring With a Traditional Paper-based Visual Analog Scale in Adults. J Am Acad Orthop Surg Glob Res Rev. 2018 Mar 23;2(3):e088. doi: 10.5435/JAAOSGlobal-D-17-00088. eCollection 2018 Mar.

  PMID: 30211382 BACKGROUND

• Cvetanovich GL, Chalmers PN, Levy DM, Mather RC 3rd, Harris JD, Bush-Joseph CA, Nho SJ. Hip Arthroscopy Surgical Volume Trends and 30-Day Postoperative Complications. Arthroscopy. 2016 Jul;32(7):1286-92. doi: 10.1016/j.arthro.2016.01.042. Epub 2016 Apr 9.

  PMID: 27067059 BACKGROUND

• Nakano N, Khanduja V. Complications in Hip Arthroscopy. Muscles Ligaments Tendons J. 2016 Dec 21;6(3):402-409. doi: 10.11138/mltj/2016.6.3.402. eCollection 2016 Jul-Sep.

  PMID: 28066747 BACKGROUND

• Julious SA. Sample sizes for clinical trials with normal data. Stat Med. 2004 Jun 30;23(12):1921-86. doi: 10.1002/sim.1783.

  PMID: 15195324 BACKGROUND

MeSH Terms

Conditions

Femoracetabular Impingement

Condition Hierarchy (Ancestors)

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

Study Officials

• Tim Dwyer

  Women's College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tim Dwyer

CONTACT

416-323-6482; tim.dwyer@wchospital.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Neither the patient nor their surgeon will be blinded. However, outcome assessors will be blinded throughout the duration of the study. Assessors will screen for complications at follow-up visits.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Tim Dwyer, Orthopaedic Surgeon, Principal Investigator

Study Record Dates

• First Submitted: February 15, 2022
• First Posted: February 25, 2022
• Study Start: September 1, 2022
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: July 15, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)