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).
Operating table position 0° head down (Horizontal)
+ Standard straight acetabular component introducer without alignment guide.
+ Operating table position 0° head down (Horizontal)
Summary
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).
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.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.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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.9 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalGroup III
ExperimentalGroup IV
ExperimentalGroup 5
ExperimentalGroup 6
ExperimentalGroup 7
ExperimentalGroup 8
ExperimentalGroup 9
ExperimentalStudy 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