None listed
Conditions
Brief summary
The X-ACTA Cemented Short Stem is a highly polished, double tapered cemented stem that has been manufactured in wrought iron stainless steel, with a Polymethyl methacrylate (PMMA) distal centraliser. This unique design is suggested to correct stem positioning and provide uniform cement distribution. The aim of this investigation is to evaluate the radiological performance of the X-ACTA Short Cemented Stem device in patients following Total Hip Arthroplasty. The hypothesis for this study is that the X-ACTA cemented short stem is non-inferior to other commercially available cemented stems in terms of stability and degree of migration.
Interventions
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 migration), fractures and reduced functional movement, which lead to poorer patient outcomes. This has triggered the need to experiment with various materials and develop new and improved implants, that have a higher degree of bone osseointegration, provide greater range of joint movement, stability, minimised wear and reduced risk of fracture. A new cemented stem (known as X-ACTA short) has been developed in an attempt to overcome some of these shortcomings. The newly designed X-ACTA short stem device was recently introduced into the Australian market, however, its radiological performance in relation to stem stability and migration, is yet to be evaluated. One method that is commonly used to measure the degree of migration is radiostereometric analysis (RSA). This technique has been shown to be a highly precise and safe technique in assessing stem migration. Given the safety and reliability of the RSA technique, the purpose of this investigation will be to assess the stability and migration of the X-ACTA cemented short stem over a 2-year period following THA surgery and determine how this correlates with patient outcomes. All study participants will be enrolled in the trial for a period of 2-years following THA surgery. Each patient will have x-rays done at four time points (immediately post-operatively and then again at 6-months, 12-months and 2-years following surgery). Each radiological examination is expected to take 15 minutes.
Sponsors
Eligibility
Inclusion criteria
-Patients that have had a diagnosis of end-stage primary osteoarthritis who are eligible for primary total hip arthroplasty procedure -Patients assessed as being suitable for implant of the X-acta straight cemented short stem according to the indications for use (on-label) -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
Patients with Rheumatoid Arthritis -Patients with a history of active infection -Patients who experienced an adverse event post-surgery deemed to be unrelated to device implant -Patients suffering a congenital or developmental abnormality of the hip joint -Patients who experienced a perioperative fracture -Patients who have had prior surgery on the hip that has been operated on -Patients with a history or are currently being treated for psychiatric illness/mental disorder or have a cognitive impairment -Patients who are highly dependent on medical care who may be unable to give consent -Patients with a history or are currently being treated for alcohol or drug abuse