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

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

COMPLETED

Clinical Phase

NA

Total Enrollment

270 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2014-04-30

Brief Summary

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Total Hip Arthroplasty (THA) is one of the most commonly performed orthopaedic operations worldwide. The main aim is overall improvement in levels of patient pain and mobility. Such surgery involves implantation of both an acetabular and femoral component. With the patient in the lateral decubitus position, the Orthopaedic Surgeon assumes that the pelvis is in a neutral position with respect to all three body planes at the time of acetabular component implantation.

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).

Detailed Description

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Conditions

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Total Hip Arthroplasty Total Hip Replacement THA THR

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Blinding Strategy

SINGLE

Outcome Assessors

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.

Group Type EXPERIMENTAL

Operating table position 0° head down (Horizontal)

Intervention Type PROCEDURE

Standard straight acetabular component introducer without alignment guide.

Intervention Type DEVICE

0° Head Down (horizontal) & Modified 35° Introducer.

Operating table position 0°head down (horizontal) \& modified 35° acetabular component introducer.

Group Type EXPERIMENTAL

Operating table position 0° head down (Horizontal)

Intervention Type PROCEDURE

Modified 35° acetabular component introducer.

Intervention Type DEVICE

0°Head Down (horizontal) & Inclinometer-assisted Introducer.

Operating table position 0°head down (horizontal) \& standard straight acetabular component introducer without alignment guide.

Group Type EXPERIMENTAL

Operating table position 0° head down (Horizontal)

Intervention Type PROCEDURE

Inclinometer-assisted acetabular component introducer.

Intervention Type DEVICE

7° Head Down & Standard Introducer.

Operating table position 7° head down \& standard straight acetabular component introducer without alignment guide.

Group Type EXPERIMENTAL

Operating table position 7° head down.

Intervention Type PROCEDURE

Standard straight acetabular component introducer without alignment guide.

Intervention Type DEVICE

7° Head Down & Modified 35° Introducer.

Operating table position 7° head down \& modified 35° acetabular component introducer.

Group Type EXPERIMENTAL

Operating table position 7° head down.

Intervention Type PROCEDURE

Modified 35° acetabular component introducer.

Intervention Type DEVICE

7° Head Down & Inclinometer-assisted Introducer.

Operating table position 7° head down \& inclinometer-assisted acetabular component introducer.

Group Type EXPERIMENTAL

Operating table position 7° head down.

Intervention Type PROCEDURE

Inclinometer-assisted acetabular component introducer.

Intervention Type DEVICE

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.

Group Type EXPERIMENTAL

Operating table position Y° head down

Intervention Type PROCEDURE

Operating table position Y° head down (angle required to obtain vertical Transverse Pelvis Lines).

Standard straight acetabular component introducer without alignment guide.

Intervention Type DEVICE

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.

Group Type EXPERIMENTAL

Operating table position Y° head down

Intervention Type PROCEDURE

Operating table position Y° head down (angle required to obtain vertical Transverse Pelvis Lines).

Modified 35° acetabular component introducer.

Intervention Type DEVICE

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.

Group Type EXPERIMENTAL

Operating table position Y° head down

Intervention Type PROCEDURE

Operating table position Y° head down (angle required to obtain vertical Transverse Pelvis Lines).

Inclinometer-assisted acetabular component introducer.

Intervention Type DEVICE

Interventions

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Operating table position 0° head down (Horizontal)

Intervention Type PROCEDURE

Operating table position 7° head down.

Intervention Type PROCEDURE

Operating table position Y° head down

Operating table position Y° head down (angle required to obtain vertical Transverse Pelvis Lines).

Intervention Type PROCEDURE

Standard straight acetabular component introducer without alignment guide.

Intervention Type DEVICE

Modified 35° acetabular component introducer.

Intervention Type DEVICE

Inclinometer-assisted acetabular component introducer.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* All patients between the ages of 16 and 100 years awaiting primary Total Hip Arthroplasty the care of Professor D Beverland and Mr D Molloy in Musgrave Park Hospital will initially be invited to participate.

Exclusion Criteria

* Patients unable to provide fully informed consent.
Minimum Eligible Age

16 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Belfast Arthroplasty Research Trust (BART)

UNKNOWN

Sponsor Role collaborator

Belfast Health and Social Care Trust

OTHER

Sponsor Role collaborator

Queen's University, Belfast

OTHER

Sponsor Role collaborator

Musgrave Park Hospital

OTHER

Sponsor Role lead

Responsible Party

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Professor David Beverland

Consultant Orthopaedic Surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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United Kingdom

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.

Reference Type BACKGROUND
PMID: 20798436 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30165765 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30165761 (View on PubMed)

Other Identifiers

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12080DB-SW

Identifier Type: -

Identifier Source: org_study_id

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