Robotic Instrumentation in THA
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Jacksonville, Florida: 23-009887
NCT ID: NCT05497206
Sponsor Protocol Number: CMU2021-26 TDS
About this study
The purpose of this study is to evaluate the accuracy of acetabular implant position using a robotic-arm surgical assistant (ROSA® Hip System) (rTHA).
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
More information
Publications
Publications are currently not available