Early Versus Delayed Weightbearing in Femoroacetabular Impingement Syndrome Patients

Femoroacetabular Impingement Syndrome Clinical Trial

— FASTHIP  

Official title:

Early Versus Delayed Weightbearing in FemoroAcetabular Impingement Syndrome Patients Undergoing Treatment With Arthroscopic HIP Osteochondroplasty: a Randomized Controlled Non-inferiority Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05256628
• Other study ID #: 2020-0154-B
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2022
• Est. completion date: April 2024

Study information

• Verified date: July 2022
• Source: Women's College Hospital
• Contact: Tim Dwyer
• Phone: 416-323-6482
• Email: tim.dwyer[@]wchospital.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Hip arthroscopy is used in the surgical treatment of femoroacetabular impingement syndrome (FAIS). There remains debate as to whether patients should be restricted to touch weightbearing post-operatively to prevent complications and improve clinical outcomes. This study aims to assess whether early weightbearing will produce non-inferior patient reported outcomes compared to protected touch weightbearing at 1 year post-operatively. We hypothesize that patients who are allowed to bear weight immediately after surgery will have non-inferior outcomes in comparison to those allowed to bear weight at 6 weeks post-operatively. The FASTHIP trial is a multi-center, non-inferiority randomized controlled trial, looking at patients who are 16-50 years old, undergoing hip arthroscopy and osteochondroplasty for femoroacetabular impingement syndrome. All patients will be under general anesthesia, supine on a traction table. They will then undergo hip arthroscopy and associated procedures according to their respective surgeon's typical practice. This will result in different surgical techniques being represented in this study, with variances in portal placement, bone resection strategy, labral repair strategy and capsular closure technique. This is meant to reflect the true practice variances among hip arthroscopists and is inherent in the pragmatic nature of the trial. Participants will be randomized into one of two groups (immediate weightbearing as tolerated vs. touch weightbearing for 6 weeks following hip arthroscopy) in a 1:1 fashion using a computer-generated randomization schedule. Following surgery, all participants will receive a post-operative prescription of acetaminophen for three days, followed by Celebrex daily, and a conservative number of opioids for pain control. All participants will also receive standardized physiotherapy instructions outlining a phased approach from early joint protection and range of motion, to strengthening and sport specific goals in subsequent months. Initially, patients will be restricted to: hip extension 0, flexion 90, abduction 0, adduction 30 and limited external, internal rotation. At 6 weeks patients progress to full ROM and strengthening exercises. Return to sport targets instructions will be patient and sport specific, but generally recommended at 6 months. Following screening, consent, collection of baseline data, and surgery, patients will be seen post-operatively at 2-weeks, 6-weeks, 3-months, 6-months, 1-year, and 2-years. Patient reported outcomes will be collected at 6 weeks, 3 months, 6-months, 1-year and 2-year appointments.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 240
• Est. completion date: April 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 50 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Femoracetabular Impingement
• Femoroacetabular Impingement Syndrome
• Rotator Cuff Injuries
• Syndrome

Intervention

Other:
• Early Weightbearing
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.
• Protected Weightbearing
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.

Locations

Country	Name	City	State
Canada	Women's College Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Women's College Hospital	University of Toronto Orthopaedic Sports Medicine

Country where clinical trial is conducted

Canada, 

References & Publications (40)

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. — View Citation

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. — View Citation

Andersson L, Wesslau A, Bodén H, Dalén N. Immediate or late weight bearing after uncemented total hip arthroplasty: a study of functional recovery. J Arthroplasty. 2001 Dec;16(8):1063-5. — View Citation

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. Erratum in: Arthroscopy. 2020 Mar;36(3):923. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Ganz R, Parvizi J, Beck M, Leunig M, Nötzli H, Siebenrock KA. Femoroacetabular impingement: a cause for osteoarthritis of the hip. Clin Orthop Relat Res. 2003 Dec;(417):112-20. Review. — View Citation

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. — View Citation

Griffin DR, Dickenson EJ, O'Donnell J, Agricola R, Awan T, Beck M, Clohisy JC, Dijkstra HP, Falvey E, Gimpel M, Hinman RS, Hölmich 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Julious SA. Sample sizes for clinical trials with normal data. Stat Med. 2004 Jun 30;23(12):1921-86. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

Suchak AA, Bostick GP, Beaupré 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. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

* Note: There are 40 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Hip Outcome Score, Activities of Daily Living (HOS-ADL)	The HOS-ADL consists of 17 questions that assess the impact of hip conditions on activities of daily living. Patients are asked to rate the level of difficulty in performing 17 different tasks, on a scale of 0 (unable to perform) to 4 (no difficulty at all).	Administered at baseline, 6 months, 1 year, and 2 years post-operatively
Secondary	European Quality of Life Five Dimension Five Level (EQ-5D-5L)	The EQ-5D-5L assesses patients' overall quality of life and health. This measure asks questions related to mobility, self-care, activity, pain, and anxiety/depression. The measure also includes one 0-100 scale assessing how patients perceive their overall health.	Administered at baseline, 6 months, 1 year, and 2 years post-operatively
Secondary	Pain Visual Analog Scale (VAS)	Participants will indicate their level of pain on a 10cm line that represents a spectrum ranging from no pain (left side), to severe pain (right side)	Administered at baseline, 2 weeks, 6 weeks, 3 months, 6 months, 1 year, and 2 years post-operatively
Secondary	Post-Operative Complications	Incidences of complications such as infection, deep vein thrombosis, restrictions in ROM, adhesive capsulitis, fractures, prolonged opioid use, and early reoperation will be collected and recorded.	Recorded at 2 weeks, 6 weeks, 3 months, 6 months, 1 year, and 2 years post-operatively.