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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Musgrave Park Hospital
Sponsor:
Collaborators:
Belfast Arthroplasty Research Trust (BART)
Belfast Health and Social Care Trust
Queen's University, Belfast
Information provided by (Responsible Party):
Professor David Beverland, Musgrave Park Hospital
ClinicalTrials.gov Identifier:
NCT01831401
First received: February 15, 2013
Last updated: September 5, 2013
Last verified: September 2013
  Purpose

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).


Condition Intervention
Total Hip Arthroplasty
Total Hip Replacement
THA
THR
Procedure: Operating table position 0° head down (Horizontal)
Procedure: Operating table position 7° head down.
Procedure: Operating table position Y° head down
Device: Standard straight acetabular component introducer without alignment guide.
Device: Modified 35° acetabular component introducer.
Device: Inclinometer-assisted acetabular component introducer.

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
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).

Further study details as provided by Musgrave Park Hospital:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

    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. ] [ Designated as safety issue: No ]

    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.


Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Estimated Enrollment: 275
Study Start Date: August 2013
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 0° Head Down (horizontal) & Standard Introducer.
Operating table position 0° head down (horizontal) & standard straight acetabular component introducer without alignment guide.
Procedure: Operating table position 0° head down (Horizontal) Device: Standard straight acetabular component introducer without alignment guide.
Experimental: 0° Head Down (horizontal) & Modified 35° Introducer.
Operating table position 0°head down (horizontal) & modified 35° acetabular component introducer.
Procedure: Operating table position 0° head down (Horizontal) Device: Modified 35° acetabular component introducer.
Experimental: 0°Head Down (horizontal) & Inclinometer-assisted Introducer.
Operating table position 0°head down (horizontal) & standard straight acetabular component introducer without alignment guide.
Procedure: Operating table position 0° head down (Horizontal) Device: Inclinometer-assisted acetabular component introducer.
Experimental: 7° Head Down & Standard Introducer.
Operating table position 7° head down & standard straight acetabular component introducer without alignment guide.
Procedure: Operating table position 7° head down.
Other Name: Operating table position 7° head down.
Device: Standard straight acetabular component introducer without alignment guide.
Experimental: 7° Head Down & Modified 35° Introducer.
Operating table position 7° head down & modified 35° acetabular component introducer.
Procedure: Operating table position 7° head down.
Other Name: Operating table position 7° head down.
Device: Modified 35° acetabular component introducer.
Experimental: 7° Head Down & Inclinometer-assisted Introducer.
Operating table position 7° head down & inclinometer-assisted acetabular component introducer.
Procedure: Operating table position 7° head down.
Other Name: Operating table position 7° head down.
Device: Inclinometer-assisted acetabular component introducer.
Experimental: 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.
Procedure: Operating table position Y° head down
Operating table position Y° head down (angle required to obtain vertical Transverse Pelvis Lines).
Device: Standard straight acetabular component introducer without alignment guide.
Experimental: 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.
Procedure: Operating table position Y° head down
Operating table position Y° head down (angle required to obtain vertical Transverse Pelvis Lines).
Device: Modified 35° acetabular component introducer.
Experimental: 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.
Procedure: Operating table position Y° head down
Operating table position Y° head down (angle required to obtain vertical Transverse Pelvis Lines).
Device: Inclinometer-assisted acetabular component introducer.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01831401

Contacts
Contact: David E Beverland, MD, FRCS(Orth) +442890902000 david.beverland@belfasttrust.hscni.net

Locations
United Kingdom
Musgrave Park Hospital Recruiting
Belfast, County Antrim, United Kingdom, BT9 7JB
Contact: David E Beverland, MD FRCS(Orth)    +442890902000    david.beverland@belfasttrust.hscni.net   
Principal Investigator: David E Beverland, MD FRCS(Orth)         
Sponsors and Collaborators
Musgrave Park Hospital
Belfast Arthroplasty Research Trust (BART)
Belfast Health and Social Care Trust
Queen's University, Belfast
Investigators
Principal Investigator: David E Beverland, MD FRCS(Orth) Musgrave Park Hospital / Belfast Health & Social Care Trust
  More Information

Publications:
Responsible Party: Professor David Beverland, Consultant Orthopaedic Surgeon, Musgrave Park Hospital
ClinicalTrials.gov Identifier: NCT01831401     History of Changes
Other Study ID Numbers: 12080DB-SW
Study First Received: February 15, 2013
Last Updated: September 5, 2013
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Musgrave Park Hospital:
Acetabular component inclination

ClinicalTrials.gov processed this record on August 19, 2014