Bone Density Analysis of Rigid vs Elastic Uncemented Acetabular Cups in Patients with Symptomatic Arthritis of the Hip.

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12615000263594
• Date of registration: 20/03/2015
• Prospective Registration: Yes
• Primary sponsor: Mathys Orthopaedics Pty Ltd
• Public title: Bone Density Analysis of Rigid vs Elastic Uncemented Acetabular Cups in Patients with Symptomatic Arthritis of the Hip.
• Scientific title: DEXA Analysis of Conventional Rigid vs. Elastic Uncemented Acetabular Cups in Patients with Symptomatic Arthritis of the Hip.
• Date of first enrolment: 01/01/2019
• Target sample size: 144
• Recruitment status: Withdrawn
• URL: https://anzctr.org.au/ACTRN12615000263594.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Safety/efficacy;
• Phase: Not Applicable

Countries of recruitment

Australia

Contacts

• Name: Dr Jenny Burke

• Name: Dr Jenny Burke

Key inclusion & exclusion criteria

Inclusion criteria: 1. Patients with symptomatic arthritis who are candidates for a primary total hip replacement with an uncemented or cemented femoral stem as determined jointly by the surgeon and the patient.
2. Patients suitable for an uncemented acetabular component
3. Patients who understand the conditions of the study and are willing to participate for the length of the prescribed follow-up

Exclusion criteria: 1. Patients who have had previous contralateral hip replacement surgery
2. Pregnant women or those seeking to become pregnant
3. Patients with a history of active infection
4. Patients with conditions or medications associated with osteoporosis or osteopenia ie: bisphosphonates, Protos, steroids and previous acetabular surgery on the affected side.
5. Patients who have severe arthritis of contralateral hip


Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Surgery - Other surgery

Symptomatic arthritis of hip;
Symptomatic arthritis of hip

Musculoskeletal - Osteoarthritis

Intervention(s)

RM Pressfit Acetabular Cup. The cup is a cementless monoblock press-fit acetabular cup and it is manufactured from UHMWPE, which is stabilised with Vitamin E. The outer surface of the polyethylene is coated with titanium particles for bony in-growth.
This device has no metal shell, and is designed to be flexible in the acetabular bone, unlike a conventional uncemented acetabular cup.
A standard total hip replacement will be performed to implant the device, according to the individual surgeons normal practice.

Primary Outcome(s)

To investigate the acetabular bone stock when using a RM Pressfit Cup compared with a conventional rigid uncemented acetabular cup as assessed by DEXA analysis.

[2 years]

Secondary Outcome(s)

To examine whether the RM Pressfit Vitamys Cup performs as well as conventional acetabular cups with regards to function using the Oxford Hip Score. Average scores will be compared between the RM Pressfit Cup group and the comparison group.[5 years]

To examine whether the RM Pressfit Vitamys Cup performs as well as conventional acetabular cups with regards to quality-of-life using the Short Form 36 (SF-36) and the Assessment of Quality of Life (AQoL-6D). Average scores for each assessment will be compared between the RM Pressfit Cup group and the comparison group.[5 years]

To investigate the acetabular bone stock when using a RM Pressfit Cup compared with a conventional rigid uncemented acetabular cup as assessed by DEXA analysis.[5 years]

Secondary ID(s)

Nil known

Source(s) of Monetary Support

Mathys Orthopaedics Pty Ltd

Ethics review

Status: Approved
Approval date:
Contact:

Epworth HealthCare Human Research Ethics Committee

Status: Approved
Approval date:
Contact:

St John of God Health Care Ethics Commitee