RecruitingACTRN12620000441910

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

Prospective, Multicentre Study to Assess Performance of the Quadra-P Femoral Stem in Primary Total Hip Replacement .


Sponsor

Medacta Australia Pty Ltd

Enrollment

300 participants

Start Date

Feb 5, 2020

Study Type

Observational

Conditions

Summary

Total Hip Arthroplasty (THA) is a procedure commonly performed in patients who have end-stage hip osteoarthritis. The primary goal of THA is to provide pain relief, reduce disability, improve quality of life and functional status. Despite high implant success rates, up to 15% of patients remain dis-satisfied after surgery. This has been postulated to be due to several factors, including implant loosening, stem fractures and reduced functional movement, which lead to poorer patient outcomes. Recently, a new range of hip replacement devices have been engineered to address some of the shortcomings of existing stems. In particular, the Quadra-P stem has specifically been designed as a straight, triple tapered stem with a rectangular cross-section and manufactured with Ti-6Al-7Nb alloy material to increase osseointegration and reduce wear. The newly designed Quadra-P stem device was recently introduced into the Australian market, however, its clinical performance is yet to be evaluated. Thus, the purpose of this study is to investigate the Quadra-P stem efficacy (survival) at 2, 5 and 10 years post-surgery and ensure that it performs just as well as other commercially available stems. The hypothesis for this investigation is that the 2, 5 and 10 year percent revision rate (need to re-implant) is not inferior (comparable) to the average performance of all other cementless femoral stems currently in use in the Australian Market.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 75 Yearss

Plain Language Summary

Simplified for easier understanding

Hip replacement surgery is one of the most common and successful orthopaedic procedures, relieving pain and restoring function for people with severe hip arthritis. This study evaluates the performance of a new hip implant called the Quadra-P stem — a specially designed cementless femoral component (the part that goes into the thigh bone) made from a titanium alloy with a hydroxyapatite coating to encourage bone integration. Participants who are scheduled for primary total hip replacement and are suitable for this type of cementless implant receive the Quadra-P stem and are then followed up at 2, 5, and 10 years. Outcomes including revision rates (needing a second operation), pain relief, and functional improvement are tracked. The study aims to confirm the implant performs at least as well as other currently available cementless stems. You may be eligible if you are an adult under 75 years of age having your first hip replacement, are suitable for a cementless stem, and are willing to attend follow-up appointments. People with rheumatoid arthritis or a history of active infection are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

Total Hip Arthroplasty (THA) is a procedure commonly performed in patients who have end-stage hip osteoarthritis. Patients who are planned to undergo THA surgery and fit the eligibility criteria will

Total Hip Arthroplasty (THA) is a procedure commonly performed in patients who have end-stage hip osteoarthritis. Patients who are planned to undergo THA surgery and fit the eligibility criteria will be considered for enrollment in this study. Each participant will receive the new hydroxyapatite coated Quadra-P femoral stem together with either the Mpact or Versafit cementless acetabular component articular systems, as part of routine treatment for total hip replacement procedures. These devices will be implanted by qualified and experienced orthopaedic surgeons as per routine practice and all observational participant data will be collected into the AOANJRR registry as per standard protocols. Several patient reported outcome measures (PROMS) in the form of questionnaires, will be collected and analysed by the AOANJRR during the pre-operative visit and again at 6 month, 1 year, 2 years, 5 years and 10 years time points post-procedure. Each patient will receive SMS/email reminders at each time to log into an online portal and complete each of the questionnaires, at the participant's home using an electronic device of their choice.


Locations(1)

NSW,QLD,SA,VIC, Australia

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12620000441910