Pillow Use During Total Hip Arthroplasty

Arthroplasty, Replacement, Hip Clinical Trial

Official title:

Can the Difference Between the Operative and Radiographic Cup Inclination Angle Be Reduced by Applying a Pillow Between the Patient's Legs in Total Hip Arthroplasty Performed In The Lateral Decubitus Position?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03825029
• Other study ID #: 20190058
• Status: Recruiting
• Phase: N/A
• Start date: July 22, 2019
• Est. completion date: September 2021

Study information

• Verified date: August 2020
• Source: Ottawa Hospital Research Institute
• Contact: Johanna Dobransky, MHK, BSc, CCRP
• Phone: 6137378899
• Email: jdobransky[@]ohri.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthroplasty, Replacement, Hip
• Hip Replacement, Total

Intervention

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

Locations

Country	Name	City	State
Canada	The Ottawa Hospital	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute

Country where clinical trial is conducted

Canada, 

References & Publications (10)

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. — View Citation

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. — View Citation

Grammatopoulos G, Pandit HG, da Assunção 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)