Robotic Instrumentation in THA

Overview

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.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Luke Spencer Gardner, M.D.

Open for enrollment

Contact information:

Clinical Studies Unit

(904) 953-2255

More information

Publications

Publications are currently not available