A study of initial total hip replacement using a cementless hip implant that has been coated with a bio-active material.

Not Applicable

Withdrawn

• Conditions: Osteoarthritis; Musculoskeletal - Osteoarthritis; Surgery - Other surgery

• Registration Number: ACTRN12618000203257
• Lead Sponsor: MAC Surgical

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-02-08
• Last Update Posted: 4 February 2019

Recruitment & Eligibility

• Status: Withdrawn
• Sex: All
• Target Recruitment: 222

Inclusion Criteria

Participants with symptomatic arthritis who are candidates for a primary total hip replacement with an uncemented femoral stem as determined jointly by the surgeon and the patient
Age - 75 years or less
Patients who understand the conditions of the study and are willing to participate for the length of the prescribed follow-up period

Exclusion Criteria

Patients with rheumatoid arthritis
Patients with a history of active infection
Patients with conditions or medications associated with osteoporosis or osteopenia
Pregnant women or those seeking to become pregnant

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Micro-motion of the prosthesis within the bone. This is measured by RSA x-ray analysis.[Three years post surgery]

Secondary Outcome Measures

Name	Time	Method
Quality of Life as measured with EQ-5D-5L questionnaire[6 weeks, 6 months, 1 year, 2 years, 3 years post surgery];Clinical outcomes as measured with Harris Hip Score questionnaire[6 weeks, 6 months, 1 year, 2 years, 3 years post surgery]