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

Not Applicable

Withdrawn

• Conditions: Symptomatic arthritis of hip; Musculoskeletal - Osteoarthritis; Surgery - Other surgery

• Registration Number: ACTRN12615000263594
• Lead Sponsor: Mathys Orthopaedics Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-03-20
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Withdrawn
• Sex: All
• Target Recruitment: 144

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br><br>[2 years]

Secondary Outcome Measures

Name	Time	Method
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];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]