Completed

A Randomised Controlled Study Investigating 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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What is being tested

Operating table position 0° head down (Horizontal)

+ Standard straight acetabular component introducer without alignment guide.

+ Operating table position 0° head down (Horizontal)

ProcedureDevice
Who is being recruted

From 16 to 100 Years
+2 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Interventional
Study Start: August 2013
See protocol details

Summary

Principal SponsorMusgrave Park Hospital
Last updated: March 22, 2016
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 2013

Actual date on which the first participant was enrolled.

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).

Principal SponsorMusgrave Park Hospital
Last updated: March 22, 2016
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

270 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 16 to 100 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

1 inclusion criteria required to participate
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

1 exclusion criteria prevent from participating
Patients unable to provide fully informed consent

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

9 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Group II

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

Group III

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

Group IV

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

Group 5

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

Group 6

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

Group 7

Experimental
Operating table position Y° head down (angle required to obtain vertical Transverse Pelvis Lines) & standard straight acetabular component introducer without alignment guide.

Group 8

Experimental
Operating table position Y° head down (angle required to obtain vertical Transverse Pelvis Lines) & modified 35°acetabular component introducer.

Group 9

Experimental
Operating table position Y° head down (angle required to obtain vertical Transverse Pelvis Lines) & inclinometer-assisted acetabular component introducer.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Musgrave Park Hospital

Belfast, United KingdomOpen Musgrave Park Hospital in Google Maps
CompletedOne Study Center