Clinical Trials

Inclusion Criteria:

• Age 18 – 80 years.
• Body mass index ≤ 40 (BMI = kg/m^2).
• Patient is willing and able to provide informed consent.
• Patient qualifies for primary THA, via an anterior approach, due to osteoarthritis or avascular necrosis of the hip based on Investigator’s clinical judgment.
• Independent of study participation, patient is a candidate and meets the indications and none of the contraindications for use with the ROSA Hip System.

Exclusion Criteria:

• Has undergone an orthopaedic procedure of the spine or lower extremity, or is currently participating in a pain management clinical study of any joint, within the last 6 months or planned within the next 6 months.
• Patients receiving simultaneous bilateral hip arthroplasties are excluded from participation in this study; as well as any participants with staged bilateral arthroplasties within 6 months of each other.
• Active infection, sepsis, osteomyelitis.
• Patient is at a high risk for dislocation including those with lumbar spinal fusions and neuromuscular disorders.
• Inflammatory (rheumatoid or psoriatic arthritis) or post-traumatic arthropathy, or any other degenerative joint disease not consistent with osteoarthritis.
• Would, in the Investigator’s opinion, be unwilling or unable to comply with the postoperative follow-up schedule.
• Patient is considered a member of a vulnerable population (pregnant, prisoner, mentally incompetent, etc.).
• Previous hardware in the proximal femur or acetabulum from a prior orthopaedic procedure.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 9/21/23. Questions regarding updates should be directed to the study team contact.