Dislocation Precautions

NCT03806114 | Unknown DMC

• 1 other identifier: 20180880
• Study Type: interventional
• Target: 212
• Locations: 1 country
• Sites: 1

Brief Summary

This study is looking at the impact of giving patients precautions, or restrictions for movement, when undergoing a total hip replacement. Have of the participants will receive precautions, while the other half will not receive any precautions.

Conditions

Arthroplasty, Hip Replacement; Arthroplasties, Hip Replacement; Health-Related Quality Of Life

Outcome Measures

Primary Outcomes (1)

• Change in Oxford Hip Score

  Assess function of the hip

  Week before surgery to 6 months after surgery

Secondary Outcomes (4)

• Change in Tampa Scale for Kinesiophobia

  Week before surgery to 6 months after surgery

• Change in Forgotten Joint Score

  6 weeks after surgery to 6 months after surgery

• Change in EQ-5D-5L

  Week before surgery to 6 months after surgery

• Canadian Patient Experience Survey - Inpatient Care (CPES-IC)

  At 2 weeks after surgery

Study Arms (4)

Anterior Approach Precautions

OTHER

This group receives precautions and have a total hip arthroplasty with a posterior approach.

Procedure: Anterior Approach Precautions

Posterior Approach Precautions

OTHER

This group receives precautions and have a total hip arthroplasty with a posterior approach.

Procedure: Posterior Approach Precautions

Anterior Approach No Precautions

OTHER

This group receives does not precautions and have a total hip arthroplasty with an anterior approach.

Procedure: No Precautions

Posterior Approach No Precautions

OTHER

This group receives does not receive precautions and have a total hip arthroplasty with a posterior approach.

Procedure: No Precautions

Interventions

Posterior Approach Precautions PROCEDURE

These patients will be advised not to bend their leg or trunk more than 90 degrees, avoid crossing the leg or crossing midline, and rotating the leg inwards. Patients will also be instructed to put a pillow in between their legs while sleeping for 6 weeks and to avoid bathing for 6 weeks.

Posterior Approach Precautions

Anterior Approach Precautions PROCEDURE

These patients will be advised to avoid extending the leg back, rotating the leg outwards, and lifting their bottom when lying down after their surgery for 6 weeks.

Anterior Approach Precautions

No Precautions PROCEDURE

For the non-precautions group, there will be no mention of precautions by any providers before, during, and after surgery. No equipment will be given, but a list of self-care equipment will be available for 'comfort' purposes. Patients will be instructed to avoid bathing for 4 weeks. All groups will have instructions to use a walking aid and a toilet seat if needed, to weight-bear as tolerated, and to avoid driving for 3 weeks.

Anterior Approach No Precautions; Posterior Approach No Precautions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Receiving a primary total hip arthroplasty (THA) due to osteoarthritis or osteonecrosis
• Over 18
• Willing and able to sign consent

You may not qualify if:

• Receiving a lateral approach hip arthroplasty
• Cannot make follow up visits

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (1)

The Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

RECRUITING

Related Publications (21)

• Seagrave KG, Troelsen A, Malchau H, Husted H, Gromov K. Acetabular cup position and risk of dislocation in primary total hip arthroplasty. Acta Orthop. 2017 Feb;88(1):10-17. doi: 10.1080/17453674.2016.1251255. Epub 2016 Nov 23.

  PMID: 27879150 BACKGROUND

• Smith TO, Jepson P, Beswick A, Sands G, Drummond A, Davis ET, Sackley CM. Assistive devices, hip precautions, environmental modifications and training to prevent dislocation and improve function after hip arthroplasty. Cochrane Database Syst Rev. 2016 Jul 4;7(7):CD010815. doi: 10.1002/14651858.CD010815.pub2.

  PMID: 27374001 BACKGROUND

• van der Weegen W, Kornuijt A, Das D. Do lifestyle restrictions and precautions prevent dislocation after total hip arthroplasty? A systematic review and meta-analysis of the literature. Clin Rehabil. 2016 Apr;30(4):329-39. doi: 10.1177/0269215515579421. Epub 2015 Mar 31.

  PMID: 25834275 BACKGROUND

• Barnsley L, Barnsley L, Page R. Are Hip Precautions Necessary Post Total Hip Arthroplasty? A Systematic Review. Geriatr Orthop Surg Rehabil. 2015 Sep;6(3):230-5. doi: 10.1177/2151458515584640.

  PMID: 26328242 BACKGROUND

• Westby MD, Brittain A, Backman CL. Expert consensus on best practices for post-acute rehabilitation after total hip and knee arthroplasty: a Canada and United States Delphi study. Arthritis Care Res (Hoboken). 2014 Mar;66(3):411-23. doi: 10.1002/acr.22164.

  PMID: 24023047 BACKGROUND

• Vissers MM, Bussmann JB, Verhaar JA, Busschbach JJ, Bierma-Zeinstra SM, Reijman M. Psychological factors affecting the outcome of total hip and knee arthroplasty: a systematic review. Semin Arthritis Rheum. 2012 Feb;41(4):576-88. doi: 10.1016/j.semarthrit.2011.07.003. Epub 2011 Oct 28.

  PMID: 22035624 BACKGROUND

• Swinkels-Meewisse EJ, Swinkels RA, Verbeek AL, Vlaeyen JW, Oostendorp RA. Psychometric properties of the Tampa Scale for kinesiophobia and the fear-avoidance beliefs questionnaire in acute low back pain. Man Ther. 2003 Feb;8(1):29-36. doi: 10.1054/math.2002.0484.

  PMID: 12586559 BACKGROUND

• Pincus T, Vogel S, Burton AK, Santos R, Field AP. Fear avoidance and prognosis in back pain: a systematic review and synthesis of current evidence. Arthritis Rheum. 2006 Dec;54(12):3999-4010. doi: 10.1002/art.22273.

  PMID: 17133530 BACKGROUND

• Darlow B, Fullen BM, Dean S, Hurley DA, Baxter GD, Dowell A. The association between health care professional attitudes and beliefs and the attitudes and beliefs, clinical management, and outcomes of patients with low back pain: a systematic review. Eur J Pain. 2012 Jan;16(1):3-17. doi: 10.1016/j.ejpain.2011.06.006.

  PMID: 21719329 BACKGROUND

• Macedo LG, Smeets RJ, Maher CG, Latimer J, McAuley JH. Graded activity and graded exposure for persistent nonspecific low back pain: a systematic review. Phys Ther. 2010 Jun;90(6):860-79. doi: 10.2522/ptj.20090303. Epub 2010 Apr 15.

  PMID: 20395306 BACKGROUND

• Webster F, Perruccio AV, Jenkinson R, Jaglal S, Schemitsch E, Waddell JP, Venkataramanan V, Bytautas J, Davis AM. Understanding why people do or do not engage in activities following total joint replacement: a longitudinal qualitative study. Osteoarthritis Cartilage. 2015 Jun;23(6):860-7. doi: 10.1016/j.joca.2015.02.013. Epub 2015 Feb 21.

  PMID: 25707933 BACKGROUND

• Dawson J, Fitzpatrick R, Carr A, Murray D. Questionnaire on the perceptions of patients about total hip replacement. J Bone Joint Surg Br. 1996 Mar;78(2):185-90.

  PMID: 8666621 BACKGROUND

• Beard DJ, Harris K, Dawson J, Doll H, Murray DW, Carr AJ, Price AJ. Meaningful changes for the Oxford hip and knee scores after joint replacement surgery. J Clin Epidemiol. 2015 Jan;68(1):73-9. doi: 10.1016/j.jclinepi.2014.08.009. Epub 2014 Oct 31.

  PMID: 25441700 BACKGROUND

• Kaplan RS, Anderson SR. Time-driven activity-based costing. Harv Bus Rev. 2004 Nov;82(11):131-8, 150.

  PMID: 15559451 BACKGROUND

• Podsiadlo D, Richardson S. The timed "Up & Go": a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991 Feb;39(2):142-8. doi: 10.1111/j.1532-5415.1991.tb01616.x.

  PMID: 1991946 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

• Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007 Apr;89(4):780-5. doi: 10.2106/JBJS.F.00222.

  PMID: 17403800 BACKGROUND

• Husted H. Fast-track hip and knee arthroplasty: clinical and organizational aspects. Acta Orthop Suppl. 2012 Oct;83(346):1-39. doi: 10.3109/17453674.2012.700593.

  PMID: 23205862 BACKGROUND

• Zhang W, Moskowitz RW, Nuki G, Abramson S, Altman RD, Arden N, Bierma-Zeinstra S, Brandt KD, Croft P, Doherty M, Dougados M, Hochberg M, Hunter DJ, Kwoh K, Lohmander LS, Tugwell P. OARSI recommendations for the management of hip and knee osteoarthritis, part I: critical appraisal of existing treatment guidelines and systematic review of current research evidence. Osteoarthritis Cartilage. 2007 Sep;15(9):981-1000. doi: 10.1016/j.joca.2007.06.014. Epub 2007 Aug 27.

  PMID: 17719803 BACKGROUND

• Withers TM, Lister S, Sackley C, Clark A, Smith TO. Is there a difference in physical activity levels in patients before and up to one year after unilateral total hip replacement? A systematic review and meta-analysis. Clin Rehabil. 2017 May;31(5):639-650. doi: 10.1177/0269215516673884. Epub 2016 Oct 23.

  PMID: 27773874 BACKGROUND

• Jones CA, Martin RS, Westby MD, Beaupre LA. Total joint arthroplasty: practice variation of physiotherapy across the continuum of care in Alberta. BMC Health Serv Res. 2016 Nov 4;16(1):627. doi: 10.1186/s12913-016-1873-9.

  PMID: 27809849 BACKGROUND

Central Study Contacts

Johanna Dobransky

CONTACT

613-737-8899; jdobransky@ohri.ca

Meaghan Dufresne

CONTACT

613-737-8899; meadufresne@ohri.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2019
• First Posted: January 16, 2019
• Study Start: June 21, 2019
• Primary Completion: June 21, 2023
• Study Completion: December 21, 2023
• Last Updated: August 8, 2022

Record last verified: 2022-08

Locations

CA (1)