Dislocation Precautions

NCT ID: NCT03806114

Last Updated: 2022-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

212 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-21

Study Completion Date

2023-12-21

Brief Summary

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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.

Detailed Description

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Patients undergoing hip replacements are often told by health care providers to avoid specific positions and activities to decrease the risk of their hip dislocating following their surgery. This, however, results in patients becoming more fearful of moving and leads to limitations in their function and decreased quality of life. Previous research has shown that hip dislocations following surgery are most commonly attributed to poor implant position rather than the actions of the patients. Teaching precautions takes up healthcare resources and may use finances that are not necessarily required. This study aims to compare groups with half receiving precautions and half not receiving precautions, to assess the impact of precautions on the patients' quality of life.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Anterior Approach Precautions

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

Group Type OTHER

Anterior Approach Precautions

Intervention Type 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.

Posterior Approach Precautions

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

Group Type OTHER

Posterior Approach Precautions

Intervention Type 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.

Anterior Approach No Precautions

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

Group Type OTHER

No Precautions

Intervention Type 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.

Posterior Approach No Precautions

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

Group Type OTHER

No Precautions

Intervention Type 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.

Interventions

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Posterior Approach Precautions

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.

Intervention Type PROCEDURE

Anterior Approach Precautions

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.

Intervention Type PROCEDURE

No Precautions

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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Receiving a lateral approach hip arthroplasty
* Cannot make follow up visits
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ottawa Hospital Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The Ottawa Hospital

Ottawa, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Johanna Dobransky

Role: CONTACT

613-737-8899 ext. 78785

Meaghan Dufresne

Role: CONTACT

613-737-8899

Facility Contacts

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Johanna Dobransky

Role: primary

613-737-8899 ext. 78785

References

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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.

Reference Type BACKGROUND
PMID: 27879150 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27374001 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25834275 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26328242 (View on PubMed)

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.

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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.

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Reference Type BACKGROUND
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Reference Type BACKGROUND
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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.

Reference Type BACKGROUND
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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.

Reference Type BACKGROUND
PMID: 8666621 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25441700 (View on PubMed)

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Reference Type BACKGROUND
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Reference Type BACKGROUND
PMID: 1991946 (View on PubMed)

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Reference Type BACKGROUND
PMID: 21479777 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17403800 (View on PubMed)

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Reference Type BACKGROUND
PMID: 23205862 (View on PubMed)

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.

Reference Type BACKGROUND
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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.

Reference Type BACKGROUND
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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.

Reference Type BACKGROUND
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Other Identifiers

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20180880

Identifier Type: -

Identifier Source: org_study_id

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