A Study Investigating the Effect of Patient Pelvic Positioning and Method of Acetabular Component Insertion on Acetabular Component Inclination During Total Hip Arthroplasty (THA)
NCT ID: NCT01831401
Last Updated: 2016-03-22
Study Results
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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COMPLETED
NA
270 participants
INTERVENTIONAL
2013-08-31
2014-04-30
Brief Summary
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With regard to THA, the current orthopaedic literature demonstrates a clear relationship between acetabular component positioning, polyethylene wear and risk of dislocation. Problems with edge loading, stripe wear and squeaking are also associated with higher acetabular inclination angles, particularly in hard-on-hard bearing implants.
The important parameters of acetabular component positioning are depth, height, version and inclination.
Control of acetabular component inclination, particularly in the lateral decubitus position, is difficult and remains a challenge for the Orthopaedic Surgeon.
Accurate implantation of the acetabular component within the 'safe zone' of radiological inclination is dependent on:
* Operative version
* Operative inclination
* Pelvic position (Primarily, but not exclusively, abduction / adduction.)
This study aims to investigate the effect of patient pelvic positioning and method of acetabular component insertion on acetabular component inclination during Total Hip Arthroplasty (THA).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
SINGLE
Study Groups
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0° Head Down (horizontal) & Standard Introducer.
Operating table position 0° head down (horizontal) \& standard straight acetabular component introducer without alignment guide.
Operating table position 0° head down (Horizontal)
Standard straight acetabular component introducer without alignment guide.
0° Head Down (horizontal) & Modified 35° Introducer.
Operating table position 0°head down (horizontal) \& modified 35° acetabular component introducer.
Operating table position 0° head down (Horizontal)
Modified 35° acetabular component introducer.
0°Head Down (horizontal) & Inclinometer-assisted Introducer.
Operating table position 0°head down (horizontal) \& standard straight acetabular component introducer without alignment guide.
Operating table position 0° head down (Horizontal)
Inclinometer-assisted acetabular component introducer.
7° Head Down & Standard Introducer.
Operating table position 7° head down \& standard straight acetabular component introducer without alignment guide.
Operating table position 7° head down.
Standard straight acetabular component introducer without alignment guide.
7° Head Down & Modified 35° Introducer.
Operating table position 7° head down \& modified 35° acetabular component introducer.
Operating table position 7° head down.
Modified 35° acetabular component introducer.
7° Head Down & Inclinometer-assisted Introducer.
Operating table position 7° head down \& inclinometer-assisted acetabular component introducer.
Operating table position 7° head down.
Inclinometer-assisted acetabular component introducer.
Y° Head Down & Standard Introducer.
Operating table position Y° head down (angle required to obtain vertical Transverse Pelvis Lines) \& standard straight acetabular component introducer without alignment guide.
Operating table position Y° head down
Operating table position Y° head down (angle required to obtain vertical Transverse Pelvis Lines).
Standard straight acetabular component introducer without alignment guide.
Y° Head Down & Modified 35° Introducer.
Operating table position Y° head down (angle required to obtain vertical Transverse Pelvis Lines) \& modified 35°acetabular component introducer.
Operating table position Y° head down
Operating table position Y° head down (angle required to obtain vertical Transverse Pelvis Lines).
Modified 35° acetabular component introducer.
Y° Head Down & Inclinometer-assisted Introducer.
Operating table position Y° head down (angle required to obtain vertical Transverse Pelvis Lines) \& inclinometer-assisted acetabular component introducer.
Operating table position Y° head down
Operating table position Y° head down (angle required to obtain vertical Transverse Pelvis Lines).
Inclinometer-assisted acetabular component introducer.
Interventions
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Operating table position 0° head down (Horizontal)
Operating table position 7° head down.
Operating table position Y° head down
Operating table position Y° head down (angle required to obtain vertical Transverse Pelvis Lines).
Standard straight acetabular component introducer without alignment guide.
Modified 35° acetabular component introducer.
Inclinometer-assisted acetabular component introducer.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
16 Years
100 Years
ALL
No
Sponsors
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Belfast Arthroplasty Research Trust (BART)
UNKNOWN
Belfast Health and Social Care Trust
OTHER
Queen's University, Belfast
OTHER
Musgrave Park Hospital
OTHER
Responsible Party
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Professor David Beverland
Consultant Orthopaedic Surgeon
Principal Investigators
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David E Beverland, MD FRCS(Orth)
Role: PRINCIPAL_INVESTIGATOR
Musgrave Park Hospital / Belfast Health & Social Care Trust
Locations
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Musgrave Park Hospital
Belfast, County Antrim, United Kingdom
Countries
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References
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Hill JC, Gibson DP, Pagoti R, Beverland DE. Photographic measurement of the inclination of the acetabular component in total hip replacement using the posterior approach. J Bone Joint Surg Br. 2010 Sep;92(9):1209-14. doi: 10.1302/0301-620X.92B9.24476.
O'Neill CKJ, Magill P, Hill JC, Patterson CC, Molloy DO, Gill HS, Beverland DE. Correction of pelvic adduction during total hip arthroplasty reduces variability in radiographic inclination: findings of a randomised controlled trial. Hip Int. 2018 May;28(3):240-245. doi: 10.1177/1120700018777480.
O'Neill CKJ, Hill JC, Patterson CC, Molloy DO, Gill HS, Beverland DE. Reducing variability in apparent operative inclination during total hip arthroplasty: findings of a randomised controlled trial. Hip Int. 2018 May;28(3):234-239. doi: 10.1177/1120700018777485.
Other Identifiers
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12080DB-SW
Identifier Type: -
Identifier Source: org_study_id
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