Total Hip ArthroplastyNCT01831401

A Study Investigating the Effect of Patient Pelvic Positioning and Method of Acetabular Component Insertion on Acetabular Component Inclination During Total Hip Arthroplasty (THA)

A study testing Operating table position 0° head down (Horizontal), Operating table position 7° head down. and Operating table position Y° head down in people with Total Hip Arthroplasty and Total Hip Replacement, run by Musgrave Park Hospital at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 16 to 100 years
Conditions the study is for: Total Hip Arthroplasty, Total Hip Replacement, THA
What is being tested?: Operating table position 0° head down (Horizontal), Operating table position 7° head down. and Operating table position Y° head down
Type of treatment: Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 270 participants
Where: 1 siteUnited Kingdom
Study dates: Aug 2013to Apr 2014
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 16 to 100 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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.

Who cannot join

Patients unable to provide fully informed consent.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Musgrave Park Hospital
Belfast, County Antrim, BT9 7JB

Other trials in United Kingdom

About this study

Official title: 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).

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).

Conditions: Total Hip Arthroplasty, Total Hip Replacement, THA, THR
Being tested: Operating table position 0° head down (Horizontal), Operating table position 7° head down., Operating table position Y° head down, Standard straight acetabular component introducer without alignment guide., Modified 35° acetabular component introducer.
Keywords: Acetabular component inclination

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Operating table position 0° head down (Horizontal)Procedure or surgery
Operating table position 7° head down.Procedure or surgery
Operating table position Y° head downProcedure or surgery
Operating table position Y° head down (angle required to obtain vertical Transverse Pelvis Lines).
Standard straight acetabular component introducer without alignment guide.Device
Modified 35° acetabular component introducer.Device
Inclinometer-assisted acetabular component introducer.Device

Study groups in NCT01831401
Study group	Role	What they receive
0° Head Down (horizontal) & Standard Introducer.	Experimental	Operating table position 0° head down (horizontal) \& standard straight acetabular component introducer without alignment guide. Receives: Procedure: Operating table position 0° head down (Horizontal); Device: Standard straight acetabular component introducer without alignment guide.
0° Head Down (horizontal) & Modified 35° Introducer.	Experimental	Operating table position 0°head down (horizontal) \& modified 35° acetabular component introducer. Receives: Procedure: Operating table position 0° head down (Horizontal); Device: Modified 35° acetabular component introducer.
0°Head Down (horizontal) & Inclinometer-assisted Introducer.	Experimental	Operating table position 0°head down (horizontal) \& standard straight acetabular component introducer without alignment guide. Receives: Procedure: Operating table position 0° head down (Horizontal); Device: Inclinometer-assisted acetabular component introducer.
7° Head Down & Standard Introducer.	Experimental	Operating table position 7° head down \& standard straight acetabular component introducer without alignment guide. Receives: Procedure: Operating table position 7° head down.; Device: Standard straight acetabular component introducer without alignment guide.
7° Head Down & Modified 35° Introducer.	Experimental	Operating table position 7° head down \& modified 35° acetabular component introducer. Receives: Procedure: Operating table position 7° head down.; Device: Modified 35° acetabular component introducer.
7° Head Down & Inclinometer-assisted Introducer.	Experimental	Operating table position 7° head down \& inclinometer-assisted acetabular component introducer. Receives: Procedure: Operating table position 7° head down.; Device: Inclinometer-assisted acetabular component introducer.
Y° Head Down & Standard Introducer.	Experimental	Operating table position Y° head down (angle required to obtain vertical Transverse Pelvis Lines) \& standard straight acetabular component introducer without alignment guide. Receives: Procedure: Operating table position Y° head down; Device: Standard straight acetabular component introducer without alignment guide.
Y° Head Down & Modified 35° Introducer.	Experimental	Operating table position Y° head down (angle required to obtain vertical Transverse Pelvis Lines) \& modified 35°acetabular component introducer. Receives: Procedure: Operating table position Y° head down; Device: Modified 35° acetabular component introducer.
Y° Head Down & Inclinometer-assisted Introducer.	Experimental	Operating table position Y° head down (angle required to obtain vertical Transverse Pelvis Lines) \& inclinometer-assisted acetabular component introducer. Receives: Procedure: Operating table position Y° head down; Device: Inclinometer-assisted acetabular component introducer.

What is being measured

The primary outcome is the main question the study is designed to answer.

Radiological acetabular component inclination.
The study has two primary aims, each with a different primary outcome.
The first primary aim is to investigate the effect of adjusting patient pelvic position in the transverse plane by using a head down position of the operating table.
This is to determine, when aiming for 35° of operative inclination, which operating table position most accurately achieves a target radiological inclination of 42° on the post-operative x-ray:
1. 0° head down (Horizontal),
2. 7° head down, or
3. Y° head down (Angle required to obtain vertical Transverse Pelvic Lines).
Measured: Radiological acetabular component inclination will be measured on the routine post-operative pelvic x-ray, usually within 48 hrs from time of surgery.
Operative Acetabular Component Inclination.
The study has two primary aims, each with a different primary outcome.
The second primary aim is to determine which of the three methods of acetabular component insertion most accurately allows the Orthopaedic Surgeon to obtain the desired operative inclination of 35° during THA when using a cementless cup:
1. Standard straight introducer without any alignment guide,
2. Modified 35° introducer with horizontal alignment guide, or
3. Digital inclinometer assisted introducer.
Measured: Operative acetabular component inclination will be measured intra-operatively.

Secondary outcomes (1)

Proportion of cases in which the target radiological inclination of 42 +/- 5° is actually obtained.
Measured: Radiological acetabular component inclination will be measured on the routine post-operative pelvic x-ray, usually within 48 hrs from time of surgery.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2013Apr 2014

First posted15 Apr 2013 (estimated)
Study startAug 2013
Primary completionApr 2014
Study completionApr 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Total Hip ArthroplastyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Allocation: Randomised
Intervention model: Factorial
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 270 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01831401
Sponsor's protocol ID: 12080DB-SW
Status last verified: Mar 2016
First submitted: 15 Feb 2013
Last updated: 22 Mar 2016
Results posted: No
Data monitoring committee: Yes

Publications

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.
PubMed 20798436
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.
PubMed 30165765
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.
PubMed 30165761

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
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Effects of Combined Pericapsular Nerve Group (PENG) and Lateral Femoral Cutaneous Nerve (LFCN) Blocks on Anaesthetic Requirements and Electroencephalographic Depth of Anaesthesia During Total Hip Arthroplasty
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Study at a glance

From the registry record, last updated by the sponsor on 22 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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).
ClinicalTrials.gov ID: NCT01831401
Acronym / sponsor ID: 12080DB-SW
Conditions: Total Hip Arthroplasty, Total Hip Replacement, THA, THR
Keywords: Acetabular component inclination
Study type: Interventional
Recruitment status: Completed
Enrolment: 270 participants (actual)
Lead sponsor: Musgrave Park HospitalUniversity, hospital or other
Collaborators: Belfast Arthroplasty Research Trust (BART), Belfast Health and Social Care Trust, Queen's University, Belfast
Study start: Aug 2013
Primary completion: Apr 2014 (actual)
Study completion: Apr 2014 (actual)
First posted: 15 Apr 2013 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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).

Study design

Allocation: Randomised
Intervention model: Factorial
Masking: Single blind (outcomes assessor)
Number of arms: 9

Arm	Type	Receives
0° Head Down (horizontal) & Standard Introducer.	Experimental	Procedure: Operating table position 0° head down (Horizontal), Device: 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.	Experimental	Procedure: Operating table position 0° head down (Horizontal), Device: Modified 35° acetabular component introducer.Operating table position 0°head down (horizontal) \& modified 35° acetabular component introducer.
0°Head Down (horizontal) & Inclinometer-assisted Introducer.	Experimental	Procedure: Operating table position 0° head down (Horizontal), Device: Inclinometer-assisted acetabular component introducer.Operating table position 0°head down (horizontal) \& standard straight acetabular component introducer without alignment guide.
7° Head Down & Standard Introducer.	Experimental	Procedure: Operating table position 7° head down., Device: 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.	Experimental	Procedure: Operating table position 7° head down., Device: Modified 35° acetabular component introducer.Operating table position 7° head down \& modified 35° acetabular component introducer.
7° Head Down & Inclinometer-assisted Introducer.	Experimental	Procedure: Operating table position 7° head down., Device: Inclinometer-assisted acetabular component introducer.Operating table position 7° head down \& inclinometer-assisted acetabular component introducer.
Y° Head Down & Standard Introducer.	Experimental	Procedure: Operating table position Y° head down, Device: Standard straight acetabular component introducer without alignment guide.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.	Experimental	Procedure: Operating table position Y° head down, Device: Modified 35° acetabular component introducer.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.	Experimental	Procedure: Operating table position Y° head down, Device: Inclinometer-assisted acetabular component introducer.Operating table position Y° head down (angle required to obtain vertical Transverse Pelvis Lines) \& inclinometer-assisted acetabular component introducer.

Who may qualify

Ages: 16 to 100 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (1 listed)

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.

Key exclusion criteria (1 listed)

Patients unable to provide fully informed consent.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Operating table position 0° head down (Horizontal)	Procedure or surgery	0° Head Down (horizontal) & Modified 35° Introducer., 0° Head Down (horizontal) & Standard Introducer., 0°Head Down (horizontal) & Inclinometer-assisted Introducer.
Operating table position 7° head down.	Procedure or surgery	7° Head Down & Inclinometer-assisted Introducer., 7° Head Down & Modified 35° Introducer., 7° Head Down & Standard Introducer.
Operating table position Y° head downOperating table position Y° head down (angle required to obtain vertical Transverse Pelvis Lines).	Procedure or surgery	Y° Head Down & Inclinometer-assisted Introducer., Y° Head Down & Modified 35° Introducer., Y° Head Down & Standard Introducer.
Standard straight acetabular component introducer without alignment guide.	Device	0° Head Down (horizontal) & Standard Introducer., 7° Head Down & Standard Introducer., Y° Head Down & Standard Introducer.
Modified 35° acetabular component introducer.	Device	0° Head Down (horizontal) & Modified 35° Introducer., 7° Head Down & Modified 35° Introducer., Y° Head Down & Modified 35° Introducer.
Inclinometer-assisted acetabular component introducer.	Device	0°Head Down (horizontal) & Inclinometer-assisted Introducer., 7° Head Down & Inclinometer-assisted Introducer., Y° Head Down & Inclinometer-assisted Introducer.

Primary outcome

Radiological acetabular component inclination.
Time frame: Radiological acetabular component inclination will be measured on the routine post-operative pelvic x-ray, usually within 48 hrs from time of surgery.
The study has two primary aims, each with a different primary outcome. The first primary aim is to investigate the effect of adjusting patient pelvic position in the transverse plane by using a head down position of the operating table. This is to determine, when aiming for 35° of operative inclination, which operating table position most accurately achieves a target radiological inclination of 42° on the post-operative x-ray: 1. 0° head down (Horizontal), 2. 7° head down, or 3. Y° head down (Angle required to obtain vertical Transverse Pelvic Lines).
Operative Acetabular Component Inclination.
Time frame: Operative acetabular component inclination will be measured intra-operatively.
The study has two primary aims, each with a different primary outcome. The second primary aim is to determine which of the three methods of acetabular component insertion most accurately allows the Orthopaedic Surgeon to obtain the desired operative inclination of 35° during THA when using a cementless cup: 1. Standard straight introducer without any alignment guide, 2. Modified 35° introducer with horizontal alignment guide, or 3. Digital inclinometer assisted introducer.

1 secondary outcome

Proportion of cases in which the target radiological inclination of 42 +/- 5° is actually obtained.
Time frame: Radiological acetabular component inclination will be measured on the routine post-operative pelvic x-ray, usually within 48 hrs from time of surgery.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2016.
Background: PubMed 20798436Hill 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.
Derived from this study: PubMed 30165765O'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.
Derived from this study: PubMed 30165761O'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.

Related trials for Total Hip Arthroplasty

Recruiting
Intravenous Dexamethasone (0 vs 4 vs 8 mg) as an Adjunct to PENG Block for Postoperative Analgesia in Total Hip Arthroplasty
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

David E Beverland, MD FRCS(Orth) principal investigator

Musgrave Park Hospital / Belfast Health & Social Care Trust

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Radiological acetabular component inclination. (time frame: Radiological acetabular component inclination will be measured on the routine post-operative pelvic x-ray, usually within 48 hrs from time of surgery.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01831401, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2016.