ROSA® Hip System THA PMCF
Megadott ok: The data needed for regulatory submissions based on the current pace of the study, will not be available in the foreseeable future.
A legfontosabb adatok
- Hol
- Jacksonville és Saint Joseph (Egyesült Államok)Mind a 2 helyszín megnézése
Helyszínek itt: Egyesült Államok
- The Mayo Clinic JacksonvilleJacksonville, Egyesült ÁllamokNo longer taking part
- Mosaic Life CareSaint Joseph, Egyesült ÁllamokNo longer taking part
A vizsgálat adatai
- Ki végzi
- Zimmer Biomet
- Azonosító
- NCT05497206
- A regiszteradat frissítve
- 2026. október 13.
- Eredeti leírás
This study is a Prospective, Multicenter, Single-Arm, Cohort post-market study to evaluate the accuracy of acetabular implant position using the robotic-arm surgical assistant (ROSA® Hip System).A teljes eredeti leírásKevesebb
A Post-Market, Multi-Center, Single Arm Trial on Robotic Instrumentation (ROSA® Hip System) in Patients Undergoing Direct Anterior Total Hip Arthroplasty With Fluoroscopic Guidance
This study is a Prospective, Multicenter, Single-Arm, Cohort post-market study to evaluate the accuracy of acetabular implant position using the robotic-arm surgical assistant (ROSA® Hip System).
Inclusion:; Age 18 - 80 years; Body mass index ≤40 (BMI = kg/m2); 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:; 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 long-segment spinal fusions (>3 levels) 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.