None listed
Conditions
Brief 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 radiological performance is yet to be evaluated. It is currently unknown whether the new Quadra-P device reduces or has the same level of risk of loosening, fractures and implant displacement, compared to other commercially available stems. The purpose of this current investigation will be to evaluate the radiological performance of the Quadra-P stem in providing implant stability in patients undergoing THA.
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 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. The newly designed Quadra-P stem device was recently introduced into the Australian market (TGA approval granted 27th February 2019), however, its short and long-term clinical and radiological performance is yet to be evaluated. The AOANJRR is currently undertaking a registry-nested clinical trial (Medacta Quadra-P Femoral Stem, ACTRN12620000441910.) investigating the survivorship and patient reported outcomes (PROMs) following implantation of the Quadra-P stem in patients undergoing total hip replacement. However, it is currently unknown whether the new Quadra-P device reduces or has the same level of risk of loosening, fractures and implant displacement, compared to other commercially available stems. The purpose of this current investigation will be to determine the radiological performance of the Quadra-P stem in providing implant stability to ensure it performs as well as or better than other commercially available stems. Patients will be retrospectively recruited and all those who have already consented to be a part of the Quadra-P stem registry-nested PROMs study (ACTRN12620000441910) will be invited to participate in the radiological study. Several radiological measurements will be taken in order to evaluate the performance and stability of the Quadra-P stem. Patients will be required to have an x-ray of their replaced hip (of approximately 30 minutes duration) at 4 different time points (6-weeks, 1-year, 2-years and 5-years post-op) The specific measurements that will be collected include presence of radiolucencies (femur and acetabulum), leg length discrepancy, global offset reconstructions, stem alignment, stem subsidence and presence of femoral fracture. All patients whp
Sponsors
Medacta Australia Pty Ltd
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
• Patients agreed to participate in the Quadra-P Femoral Stem Study (ACTRN12620000441910. University of South Australia HREC project ID: 202658) • Adults aged between 18 and 75 years at the time of registration. • Patients able 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
• Patients with Rheumatoid arthritis. • Patients with a history of active infection. • Any case not described in the inclusion criteria.
Outcome results
None listed