To assess the efficacy (survivorship) of the Quadra-P Hydroxyapatite coated femoral stem in patients undergoing a primary total hip replacement surgery.

Not Applicable

Recruiting

• Conditions: Hip Osteoathritis; Musculoskeletal - Osteoarthritis

• Registration Number: ACTRN12620000441910
• Lead Sponsor: Medacta Australia Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-06
• Last Update Posted: 27 September 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Patients undergoing a primary total conventional hip replacement
- Patients assessed by the investigators as being suitable for placement of a straight, cementless stem.
- Adult male and female less than 75 years of age at time of registration
- Ability to give informed consent
- Patients who are informed of the conditions of the study are are willing to participate for the length of the prescribed follow-up

Exclusion Criteria

- Patients with Rhematoid arthritis
- Patients with a history of active infection
- Any case not described in the inclusion criteria

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

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