None listed
Conditions
Brief summary
This study is being undertaken to evaluate the safety and clinical effectiveness of the M-Finity Femoral stem with a Medacta Acetabular Cup in primary total hip arthroplasty through a CT-based migration analysis. The purpose of this study is to assess the safety and clinical effectiveness of the M-Finity in a pilot study on a small patient series. This will be achieved by both assessing the adverse events and conducting a stem migration and rotation analyses on patients who are having the M-Finity device.
Interventions
Total Hip Arthroplasty (THA) is a procedure commonly performed for end-stage hip osteoarthritis, in which the damaged bone and cartilage of the hip joint are removed and replaced with prosthetic components. The procedure involves accessing the hip joint via an appropriate surgical approach, resecting the femoral head, preparing the acetabulum and femur, and implanting the acetabular cup and femoral stem. The femoral head is then attached to the stem, and the hip is reduced to assess joint stability and leg length. Patients meeting the eligibility criteria for THA will be considered for enrolment in this study. The total surgical procedure typically takes approximately 1 to 2 hours, depending on patient anatomy and surgical approach. The implantation of the femoral stem component specifically takes approximately 20–30 minutes within this timeframe. The M-Finity femoral stem, designed for THA, aims to provide optimal fit and stability. Each participant will receive the Medacta M-Finity femoral stem along with a compatible Medacta Acetabular Cup as part of routine total hip replacement. These devices will be implanted by an experienced orthopaedic surgeon following standard practice. The study aims to evaluate the safety and clinical effectiveness of the M-Finity femoral stem, which features a triple-tapered design with reduced distal width to enhance proximal fit and minimize distal impingement. Operative reports and intraoperative checklists will be reviewed to confirm that the M-Finity femoral stem was used as intended. Implant labels will be verified to ensure traceability and correct device allocation. Any deviations from the standard procedure will be documented and reviewed by the study team.
Sponsors
Study design
Eligibility
Inclusion criteria
1. Patients undergoing a primary total hip replacement and are suitable for cementless femoral neck preserving stem according to the indications for use (On-Label use). 2. BMI less than or equal to 40. 3. Skeletally mature adults aged 18 years and over at the time of registration. 4. Ability to give informed consent. 5. 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
1. Not meeting the inclusion criteria. 2. The subject is classified as morbidly obese (BMI>40) 3. Active infection within the affected hip joint. 4. Previous total hip replacement or hip fusion of the affected hip joint. 5. Intra-articular fracture 6. Neuromuscular or neurosensory deficiency which limits the ability to evaluate the safety and effectiveness of the device. 7. Diagnosed metabolic disorder which may impair bone formation or bone quality (i.e., moderate to severe osteoporosis, Paget's disease, renal osteodystrophy) 8. Immunologically suppressed, or receiving steroids in excess of physiologic dose requirements. 9. Workers’ compensation patients or currently in any injury litigation claims 10. Women of childbearing potential