Clinical trial NCT05497206: ROSA® Hip System THA PMCF
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Osteoarthritis, Hip
Avascular Necrosis of Hip
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2022-08-11
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: Consecutive patients who meet all of the inclusion criteria and none of the exclusion criteria will be eligible for participation in the study, and will be pre-screened for participation in the informed consent process.

The primary objective of this study is to assess the accuracy of acetabular implant position by evaluating the percentage of participants who are within the range of the Callanan safe zones for Acetabular Inclination (30 - 45 degrees). A patient is considered a success if their intra-operative and/or post-operative full pelvis fluoroscopic or radiographic images show the postoperative acetabular inclination to be within this safe zone range.

Secondary Objectives include the evaluation of safety and efficacy of this system and will include the assessment of common adverse events, physical exam findings, radiologic results, and patient reported outcome measures.

Data collection will occur at the following intervals: Pre-operative, Operative, 3-months, 1-year, and 2-years. Enrollment for the study is anticipated to last approximately 18 months. Allowing for 24 months of follow-up, the total estimated study time to final-patient final-visit will be approximately 42 months.

Eligibility criteria: Inclusion:

1. Age 18 - 80 years
2. Body mass index ≤40 (BMI = kg/m2)
3. Patient is willing and able to provide informed consent
4. Patient qualifies for primary THA, via an anterior approach, due to osteoarthritis or avascular necrosis of the hip based on Investigator's clinical judgment
5. 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:

1. 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
2. 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
3. Active infection, sepsis, osteomyelitis
4. Patient is at a high risk for dislocation including those with long-segment spinal fusions (\>3 levels) and neuromuscular disorders
5. Inflammatory (rheumatoid or psoriatic arthritis) or post-traumatic arthropathy, or any other degenerative joint disease not consistent with osteoarthritis
6. Would, in the Investigator's opinion, be unwilling or unable to comply with the postoperative follow-up schedule
7. Patient is considered a member of a vulnerable population (pregnant, prisoner, mentally incompetent, etc.)
8. Previous hardware in the proximal femur or acetabulum from a prior orthopaedic procedure

Primary outcomes:
measure: Accuracy of implant position
timeFrame: 90 days
Secondary outcomes:
measure: Evaluation of Patient safety
timeFrame: 24 months
measure: Patient Reported Outcome Measure (Oxford Hip Score)
timeFrame: 24 months
measure: Numeric Pain Rating Scale (NPRS)
timeFrame: 24 months
measure: Subject Satisfaction
timeFrame: 24 months
measure: Clinical performance will be assessed with evaluation of range of motion.
timeFrame: 24 months
measure: Clinical performance will be assessed with evaluation of stability using the Trendelenburg test.
timeFrame: 24 months
measure: Clinical performance will be assessed by testing leg length discrepancy.
timeFrame: 24 months
measure: Physician Radiographic Assessment of Acetabular Cup
timeFrame: 2 Years
measure: Physician Radiographic Assessment of Femoral and Global Offset and Leg Length Discrepancy
timeFrame: 2 Years
measure: Physician Radiographic Assessment of Significant Radiographic Findings
timeFrame: 2 Years
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: The Mayo Clinic Jacksonville
state: Florida
city: Saint Joseph
country: United States
facility: Mosaic Life Care
state: Missouri
Study officials:
affiliation: Zimmer Biomet
name: Hillary Overholser
role: STUDY_DIRECTOR
References: