Pillow Use During Total Hip Arthroplasty

NCT ID: NCT03825029

Last Updated: 2020-08-12

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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-22

Study Completion Date

2021-09-30

Brief Summary

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The purpose of this study is to find out whether placing a pillow between the legs during hip surgery will result in a better aligned hip replacement.

Detailed Description

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During hip replacement surgery the cup is placed on specific planned angles. Cup placement has an effect on the patients' pain-free range of movement, dislocation rates and satisfaction. However, the angles of the cup orientation (i.e. the tilt and rotation), which are preoperatively planned and postoperatively measured on radiographs, have a high variability even when an experienced surgeon is performing the surgery. One of the reasons this occurs is because the operated leg can move the pelvis to a different position in the time between set-up and actual implantation which may lead to the cup being placed in a non-optimal position. This study aims to see if the difference between planned and achieved cup angles and pelvic movement can be lessened by putting a pillow in between the legs to keep it in a stable horizontal position.

Conditions

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Arthroplasty, Replacement, Hip Hip Replacement, Total

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pillow Group

There will be a pillow placed between the patients legs during their operation.

Group Type EXPERIMENTAL

Pillow

Intervention Type PROCEDURE

A pillow to lessen the angle differences between hips so that the acetabular component can be placed in an optimal position.

Control Group

They will receive a normal total hip arthroplasty.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Pillow

A pillow to lessen the angle differences between hips so that the acetabular component can be placed in an optimal position.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patient awaiting primary total hip arthroplasty using a posterior approach in a lateral decubitus position
* Patients capable of reading, understanding, and willing to sign the informed consent form

Exclusion Criteria

* Total hip arthroplasty not using a posterior approach in a lateral decubitus position
* Prior hip osteotomy or fracture osteosynthesis on the index hip
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

Principal Investigators

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George Grammatopoulos, MBBS BSc FRCS DPhil

Role: PRINCIPAL_INVESTIGATOR

The Ottawa Hospital Research Institute

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, MHK, BSc, CCRP

Role: CONTACT

6137378899 ext. 78785

Meaghan Dufresne

Role: CONTACT

613-737-8899 ext. 73032

Facility Contacts

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Johanna Dobransky

Role: primary

6137378899 ext. 78785

References

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Ozaki Y, Baba T, Homma Y, Ochi H, Watari T, Banno S, Matsumoto M, Kaneko K. Posterior versus direct anterior approach in total hip arthroplasty: difference in patient-reported outcomes measured with the Forgotten Joint Score-12. SICOT J. 2018;4:54. doi: 10.1051/sicotj/2018051. Epub 2016 Nov 27.

Reference Type BACKGROUND
PMID: 30480545 (View on PubMed)

Kennedy JG, Rogers WB, Soffe KE, Sullivan RJ, Griffen DG, Sheehan LJ. Effect of acetabular component orientation on recurrent dislocation, pelvic osteolysis, polyethylene wear, and component migration. J Arthroplasty. 1998 Aug;13(5):530-4. doi: 10.1016/s0883-5403(98)90052-3.

Reference Type BACKGROUND
PMID: 9726318 (View on PubMed)

D'Lima DD, Urquhart AG, Buehler KO, Walker RH, Colwell CW Jr. The effect of the orientation of the acetabular and femoral components on the range of motion of the hip at different head-neck ratios. J Bone Joint Surg Am. 2000 Mar;82(3):315-21. doi: 10.2106/00004623-200003000-00003.

Reference Type BACKGROUND
PMID: 10724224 (View on PubMed)

Grammatopoulos G, Thomas GE, Pandit H, Beard DJ, Gill HS, Murray DW. The effect of orientation of the acetabular component on outcome following total hip arthroplasty with small diameter hard-on-soft bearings. Bone Joint J. 2015 Feb;97-B(2):164-72. doi: 10.1302/0301-620X.97B2.34294.

Reference Type BACKGROUND
PMID: 25628277 (View on PubMed)

Widmer KH. [Impingement Free Motion in Total Hip Arthroplasty - How Can We Implement It?]. Z Orthop Unfall. 2016 Aug;154(4):392-7. doi: 10.1055/s-0042-108065. Epub 2016 Jun 23. German.

Reference Type BACKGROUND
PMID: 27336842 (View on PubMed)

Fujishiro T, Hiranaka T, Hashimoto S, Hayashi S, Kurosaka M, Kanno T, Masuda T. The effect of acetabular and femoral component version on dislocation in primary total hip arthroplasty. Int Orthop. 2016 Apr;40(4):697-702. doi: 10.1007/s00264-015-2924-2. Epub 2015 Jul 23.

Reference Type BACKGROUND
PMID: 26202021 (View on PubMed)

Grammatopoulos G, Pandit HG, da Assuncao R, Taylor A, McLardy-Smith P, De Smet KA, Murray DW, Gill HS. Pelvic position and movement during hip replacement. Bone Joint J. 2014 Jul;96-B(7):876-83. doi: 10.1302/0301-620X.96B7.32107.

Reference Type BACKGROUND
PMID: 24986939 (View on PubMed)

Meermans G, Goetheer-Smits I, Lim RF, Van Doorn WJ, Kats J. The difference between the radiographic and the operative angle of inclination of the acetabular component in total hip arthroplasty: use of a digital protractor and the circumference of the hip to improve orientation. Bone Joint J. 2015 May;97-B(5):603-10. doi: 10.1302/0301-620X.97B5.34781.

Reference Type BACKGROUND
PMID: 25922452 (View on PubMed)

Wright JG. Small Simple Trials: A Strategy for Orthopaedic Randomized Trials. J Bone Joint Surg Am. 2018 Jul 18;100(14):e95. doi: 10.2106/JBJS.17.01107. No abstract available.

Reference Type BACKGROUND
PMID: 30020133 (View on PubMed)

Langton DJ, Sprowson AP, Mahadeva D, Bhatnagar S, Holland JP, Nargol AV. Cup anteversion in hip resurfacing: validation of EBRA and the presentation of a simple clinical grading system. J Arthroplasty. 2010 Jun;25(4):607-13. doi: 10.1016/j.arth.2009.08.020. Epub 2009 Dec 21.

Reference Type BACKGROUND
PMID: 20022454 (View on PubMed)

Other Identifiers

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20190058

Identifier Type: -

Identifier Source: org_study_id

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