NCT03825029

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 31, 2019

Completed
6 months until next milestone

Study Start

First participant enrolled

July 22, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

August 12, 2020

Status Verified

August 1, 2020

Enrollment Period

1.9 years

First QC Date

January 29, 2019

Last Update Submit

August 11, 2020

Conditions

Arthroplasty, Replacement, HipHip Replacement, Total

Outcome Measures

Primary Outcomes (1)

  • Change in radiographic cup inclination angle

    The difference between the operative and postoperative radiographic cup inclination angle

    Intra-operatively and post-operatively (within one month after the surgery)

Study Arms (2)

Pillow Group

EXPERIMENTAL

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

Procedure: Pillow

Control Group

NO INTERVENTION

They will receive a normal total hip arthroplasty.

Interventions

PillowPROCEDURE

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

Pillow Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

RECRUITING

Related Publications (10)

  • 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.

    PMID: 30480545BACKGROUND

  • 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.

    PMID: 9726318BACKGROUND

  • 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.

    PMID: 10724224BACKGROUND

  • 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.

    PMID: 25628277BACKGROUND

  • 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.

    PMID: 27336842BACKGROUND

  • 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.

    PMID: 26202021BACKGROUND

  • 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.

    PMID: 24986939BACKGROUND

  • 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.

    PMID: 25922452BACKGROUND

  • 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.

    PMID: 30020133BACKGROUND

  • 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.

    PMID: 20022454BACKGROUND

Study Officials

  • George Grammatopoulos, MBBS BSc FRCS DPhil

    The Ottawa Hospital Research Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Johanna Dobransky, MHK, BSc, CCRP

CONTACT

6137378899jdobransky@ohri.ca

Meaghan Dufresne

CONTACT

613-737-8899meadufresne@ohri.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2019

First Posted

January 31, 2019

Study Start

July 22, 2019

Primary Completion

June 1, 2021

Study Completion

September 1, 2021

Last Updated

August 12, 2020

Record last verified: 2020-08

Locations

CA(1)