Arthroplasty, Hip ReplacementNCT03806114
Dislocation Precautions
A study testing Posterior Approach Precautions, Anterior Approach Precautions and No Precautions in people with Arthroplasty, Hip Replacement and Arthroplasties, Hip Replacement, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthroplasty, Hip Replacement, Arthroplasties, Hip Replacement, Health-Related Quality Of Life
- What is being tested?
- Posterior Approach Precautions, Anterior Approach Precautions and No Precautions
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 1 siteCanada
- Study dates
- 21 Jun 2019to 21 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Receiving a primary total hip arthroplasty (THA) due to osteoarthritis or osteonecrosis
- Over 18
- Willing and able to sign consent
Who cannot join
- Receiving a lateral approach hip arthroplasty
- Cannot make follow up visits
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
The Ottawa Hospital
Ottawa, Ontario, K1H 8L6
Johanna Dobransky, 613-737-8899 ext. 78785, jdobransky@ohri.ca
About this study
Official title: Impact of Dislocation Precautions on Fear and Function in Patients Undergoing Hip Replacement
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.
Read the detailed description
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
- Arthroplasty, Hip Replacement, Arthroplasties, Hip Replacement, Health-Related Quality Of Life
- Being tested
- Posterior Approach Precautions, Anterior Approach Precautions, No Precautions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Posterior Approach PrecautionsProcedure or surgery
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 PrecautionsProcedure or surgery
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.
No PrecautionsProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Anterior Approach Precautions | Other | This group receives precautions and have a total hip arthroplasty with a posterior approach. Receives: Procedure: Anterior Approach Precautions |
| Posterior Approach Precautions | Other | This group receives precautions and have a total hip arthroplasty with a posterior approach. Receives: 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. Receives: 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. Receives: Procedure: No Precautions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Oxford Hip Score
Assess function of the hip
Measured: Week before surgery to 6 months after surgery
Secondary outcomes (4)
Change in Tampa Scale for Kinesiophobia
This assesses kinesiophobia, using a 17 item scale with each item using a 4 point Likert scale . The final score is the sum of all questions except for 4, 8, 12 and 16 which has their score inverted before being added. The final score ranges from from 17-68 points with 68 being the highest degree of kinesiophobia.
Measured: Week before surgery to 6 months after surgery
Change in Forgotten Joint Score
This measures awareness of a replaced joint
Measured: 6 weeks after surgery to 6 months after surgery
Change in EQ-5D-5L
This measures general health
Measured: Week before surgery to 6 months after surgery
Canadian Patient Experience Survey - Inpatient Care (CPES-IC)
This will measure the patients' experience.
Measured: At 2 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2019
- Study start21 Jun 2019
- Primary completion21 Jun 2023 (estimated)
- Study completion21 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Arthroplasty, Hip ReplacementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 212 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03806114
- Sponsor's protocol ID
- 20180880
- Status last verified
- Aug 2022
- First submitted
- 14 Jan 2019
- Last updated
- 8 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 27879150Smith 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.
PubMed 27374001van 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.
PubMed 25834275Barnsley 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.
PubMed 26328242Westby 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.
PubMed 24023047Vissers 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.
PubMed 22035624Swinkels-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.
PubMed 12586559Pincus 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.
PubMed 17133530Darlow 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.
PubMed 21719329Macedo 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.
PubMed 20395306Webster 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.
PubMed 25707933Dawson 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.
PubMed 8666621Beard 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.
PubMed 25441700Kaplan RS, Anderson SR. Time-driven activity-based costing. Harv Bus Rev. 2004 Nov;82(11):131-8, 150.
PubMed 15559451Podsiadlo 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.
PubMed 1991946
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Dislocation Precautions on Fear and Function in Patients Undergoing Hip Replacement
- ClinicalTrials.gov ID
- NCT03806114
- Acronym / sponsor ID
- 20180880
- Conditions
- Arthroplasty, Hip Replacement, Arthroplasties, Hip Replacement, Health-Related Quality Of Life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 212 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- 21 Jun 2019 (actual)
- Primary completion
- 21 Jun 2023 (estimated)
- Study completion
- 21 Dec 2023 (estimated)
- First posted
- 16 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Anterior Approach Precautions | Other | Procedure: Anterior Approach PrecautionsThis group receives precautions and have a total hip arthroplasty with a posterior approach. |
| Posterior Approach Precautions | Other | Procedure: Posterior Approach PrecautionsThis group receives precautions and have a total hip arthroplasty with a posterior approach. |
| Anterior Approach No Precautions | Other | Procedure: No PrecautionsThis group receives does not precautions and have a total hip arthroplasty with an anterior approach. |
| Posterior Approach No Precautions | Other | Procedure: No PrecautionsThis group receives does not receive precautions and have a total hip arthroplasty with a posterior approach. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Receiving a primary total hip arthroplasty (THA) due to osteoarthritis or osteonecrosis
- Over 18
- Willing and able to sign consent
Key exclusion criteria (2 listed)
- Receiving a lateral approach hip arthroplasty
- Cannot make follow up visits
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Posterior Approach PrecautionsThese 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. | Procedure or surgery | Posterior Approach Precautions |
| Anterior Approach PrecautionsThese 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. | Procedure or surgery | Anterior Approach Precautions |
| No PrecautionsFor 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. | Procedure or surgery | Anterior Approach No Precautions, Posterior Approach No Precautions |
Primary outcome
Change in Oxford Hip Score
Time frame: Week before surgery to 6 months after surgery
Assess function of the hip
4 secondary outcomes
Change in Tampa Scale for Kinesiophobia
Time frame: Week before surgery to 6 months after surgery
Change in Forgotten Joint Score
Time frame: 6 weeks after surgery to 6 months after surgery
Change in EQ-5D-5L
Time frame: Week before surgery to 6 months after surgery
Canadian Patient Experience Survey - Inpatient Care (CPES-IC)
Time frame: At 2 weeks after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2022.
- Background: PubMed 27879150Seagrave 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.
- Background: PubMed 27374001Smith 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.
- Background: PubMed 25834275van 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.
- Background: PubMed 26328242Barnsley 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.
- Background: PubMed 24023047Westby 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.
- Background: PubMed 22035624Vissers 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.
- Background: PubMed 12586559Swinkels-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.
- Background: PubMed 17133530Pincus 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.
- Background: PubMed 21719329Darlow 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.
- Background: PubMed 20395306Macedo 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.
- Background: PubMed 25707933Webster 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.
- Background: PubMed 8666621Dawson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Posterior Approach Precautions, Anterior Approach Precautions and No Precautions in people with Arthroplasty, Hip Replacement and Arthroplasties, Hip Replacement, run by Ottawa Hospital Research Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Johanna Dobransky (613-737-8899 ext. 78785, jdobransky@ohri.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Oxford Hip Score (time frame: Week before surgery to 6 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03806114, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2022.