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

NCT01831401 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 270

Last updated 2016-03-22

No results posted yet for this study

Summary

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

Interventions

PROCEDURE

Operating table position 0° head down (Horizontal)

PROCEDURE

Operating table position 7° head down.

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.

DEVICE

Modified 35° acetabular component introducer.

DEVICE

Inclinometer-assisted acetabular component introducer.

Sponsors & Collaborators

  • Belfast Arthroplasty Research Trust (BART)

    collaborator UNKNOWN
  • Belfast Health and Social Care Trust

    collaborator OTHER
  • Queen's University, Belfast

    collaborator OTHER
  • Musgrave Park Hospital

    lead OTHER

Principal Investigators

  • David E Beverland, MD FRCS(Orth) · Musgrave Park Hospital / Belfast Health & Social Care Trust

Study Design

Allocation
RANDOMIZED
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
16 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2014-04-30
Completion
2014-04-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01831401 on ClinicalTrials.gov