Prospective, Multicentre Study to Assess Performance of a Monoblock Ceramic Cup Implant in Primary Total Hip Replacement

Not Applicable

• Conditions: Hip Osteoarthritis; Musculoskeletal - Osteoarthritis

• Registration Number: ACTRN12620001098921
• Lead Sponsor: Medacta Australia Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-21
• Last Update Posted: 26 October 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 280

Inclusion Criteria

Patients undergoing a primary total conventional hip replacement and are suitable for a cementless acetabular cup according to the indications for use (On-label use).
- Use of the non TGA approved (pre-market) Medacta Mpact 3D Metal MonoCer acetabular cup prosthesis.
- Adults aged between 18 and 75 years at the time of registration.
- Ability to give informed consent.
- Patients who are informed of the conditions of the study and are willing to participate for the length of the prescribed follow-up period.

Exclusion Criteria

- Rheumatoid arthritis.
- Patients with a history of active infection.
- Any case not described in the inclusion criteria.
- Revision procedures.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine Mpact 3D Metal MonoCer survivorship (efficacy) at 2, 5 and 10 years post-operatively compared to all other cementless acetabular cups. Survivorship will be assessed by determining the time to first revision surgery required following implantation of the Mpact 3D Metal MonoCer acetabular cup device. If time to first revision rates are comparable to other commercially available cups, this is indicative that Mpact 3D Metal MonoCer cup is efficacious. These estimates will be calculated using Kaplan-Meier estimates of survivorship,[2-years (primary time-point), 5 and 10 years post-operatively]