Pillow Use During Total Hip Arthroplasty

Sponsor
Ottawa Hospital Research Institute (Other)
Overall Status
Unknown status
CT.gov ID
NCT03825029
Collaborator
(none)
40
1
2
25.4
1.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Pillow
N/A

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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?
Actual Study Start Date :
Jul 22, 2019
Anticipated Primary Completion Date :
Jun 1, 2021
Anticipated Study Completion Date :
Sep 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Pillow Group

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

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

No Intervention: Control Group

They will receive a normal total hip arthroplasty.

Outcome Measures

Primary Outcome Measures

  1. Change in radiographic cup inclination angle [Intra-operatively and post-operatively (within one month after the surgery)]

    The difference between the operative and postoperative radiographic cup inclination angle

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 The Ottawa Hospital Ottawa Ontario Canada K1H 8L6

Sponsors and Collaborators

  • Ottawa Hospital Research Institute

Investigators

  • Principal Investigator: George Grammatopoulos, MBBS BSc FRCS DPhil, The Ottawa Hospital Research Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT03825029
Other Study ID Numbers:
  • 20190058
First Posted:
Jan 31, 2019
Last Update Posted:
Aug 12, 2020
Last Verified:
Aug 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Aug 12, 2020