Clinical trial NCT01831401: A Study Investigating the Effect of Patient Pelvic Positioning and Method of Acetabular Component Insertion on Acetabular Component Inclination During Total Hip Arthroplasty (THA)
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).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Total Hip Arthroplasty
Total Hip Replacement
THA
THR
Keywords: Acetabular component inclination
Lead sponsor: Musgrave Park Hospital
Sponsor class: OTHER
Collaborators: name: Belfast Arthroplasty Research Trust (BART)
name: Belfast Health and Social Care Trust
name: Queen's University, Belfast
First posted: 2013-04-15
Enrollment: 270
Sex: ALL
Minimum age (years): 16
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL

Brief 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).


Eligibility 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.

Primary outcomes:
measure: Radiological acetabular component inclination.
timeFrame: Radiological acetabular component inclination will be measured on the routine post-operative pelvic x-ray, usually within 48 hrs from time of surgery.
measure: Operative Acetabular Component Inclination.
timeFrame: Operative acetabular component inclination will be measured intra-operatively.
Secondary outcomes:
measure: Proportion of cases in which the target radiological inclination of 42 +/- 5° is actually obtained.
timeFrame: Radiological acetabular component inclination will be measured on the routine post-operative pelvic x-ray, usually within 48 hrs from time of surgery.
Other outcomes:
Locations:
city: Belfast
country: United Kingdom
facility: Musgrave Park Hospital
state: County Antrim
Study officials:
affiliation: Musgrave Park Hospital / Belfast Health & Social Care Trust
name: David E Beverland, MD FRCS(Orth)
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.