None listed
Conditions
Brief summary
The utilization of advanced 3D planning and patient specific instrumentation is rapidly increasing in the total hip arthroplasty (THA) market in Australia. Accuracy and precision are expected for these tools, yet is not well documented. This research is required to guide surgeon decision-making in the selection of appropriate THA preoperative planning methods. This study is designed to provide an objective assessment of the accuracy and precision of FORMUS LABS Pre-op Planning and OSSIS Patient Specific Instrumentation (PSI) for primary THA.
Interventions
Primary total hip arthroplasty performed using FORMUS LABS pre-operative planning and OSSIS patient-specific instrumentation (PSI) guides and Zimmer Biomet implants combines standardised implants with individualised 3D planning and cutting guides. Both FORMUS LABS and OSSIS will be responsible for providing their standardised onboarding and training procedures as part of using their products, external to the study. This will be conducted prior to recruitment.
Pre-operatively, a CT-based 3D mo
Primary total hip arthroplasty performed using FORMUS LABS pre-operative planning and OSSIS patient-specific instrumentation (PSI) guides and Zimmer Biomet implants combines standardised implants with individualised 3D planning and cutting guides. Both FORMUS LABS and OSSIS will be responsible for providing their standardised onboarding and training procedures as part of using their products, external to the study. This will be conducted prior to recruitment. Pre-operatively, a CT-based 3D model of the patient's pelvis and femur is generated, with FORMUS LABS pre-operative planning software simulating ideal implant positioning for the patient. From this plan, a 3D-printed OSSIS PSI guide is produced, which mirrors the patient's bony anatomy. Intra-operatively, the operating surgeon can physically visualise the virtual plan, to assist them with executing planned implant positioning. Post-operative assessments include CT imaging at approximately 6 weeks to assess accuracy to plan and patient-reported outcome measure (PROM) collection through to 12 months post-operatively.
Sponsors
Zimmer Biomet Pty Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Patients who are booked for primary total hip replacement to treat osteoarthritis at Fremantle Hospital
Exclusion criteria
• The individual is unable or unwilling to sign the Patient Informed Consent (PIC), specific to this study, and approved by the Institutional HREC. • The individual is less than 18 or greater than 80 years of age. • The individual is classified as morbidly obese (>40 BMI). • The individual is physically or mentally compromised (i.e., currently being treated for a psychiatric disorder, senile dementia, Alzheimer’s disease, presence of alcohol or substance abuse), and is unwilling or unable to comply with postoperative scheduled clinical and radiographic evaluation and rehabilitation. • The individual has a diagnosis other than primary osteoarthritis such as inflammatory arthritis, traumatic arthritis, avascular necrosis, slipped capital epiphysis, pelvic fracture, femoral fracture, failed fracture fixation or diastrophic variant.
Outcome results
None listed