ROSA® Hip System THA PMCF

Zimmer Biomet12 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Osteoarthritis, Hip Avascular Necrosis of Hip

Interventions

One of the following hip implants may be used within this arm of the study: G7 Acetabular System, Taperloc Complete System, Avenir and Avenir Complete Systems, and Echo Bi-Metric SystemDEVICE

Total Hip Arthroplasty

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

The Mayo Clinic Jacksonville

Jacksonville, Florida, United States

Mosaic Life Care

Saint Joseph, Missouri, United States

Outcomes

Primary Outcomes

Accuracy of implant position

To evaluate the accuracy of acetabular implant position using the robotic-arm surgical assistant (ROSA® Hip System) (rTHA). Accuracy of acetabular implant position will be assessed 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.

Time frame: 90 days

Secondary Outcomes

Evaluation of Patient safety

Frequency and incidence of adverse events, serious adverse events, adverse device effects, serious adverse device effects, and unanticipated serious adverse device effects as well as device deficiencies.

Time frame: 24 months

Patient Reported Outcome Measure (Oxford Hip Score)

A questionnaire completed by the patient consisting of twelve questions that utilize a 5-point Likert scoring system (0 - 4) resulting in a score ranging from 0 (worst) to 48 (best).

Time frame: 24 months

Numeric Pain Rating Scale (NPRS)

An 11-point NPRS is a patient self-completed reported outcome and will be used to assess the current level of pain for the affected hip. On this scale, 0 will indicate no pain and 10 will indicate the worst pain imaginable

Time frame: 24 months

Subject Satisfaction

A questionnaire consisting of a single satisfaction question in regard to the subjects hip replacement. Answers will include the following: Very Dissatisfied, Dissatisfied, Neutral, Satisfied, Very Satisfied.

Time frame: 24 months

Data from ClinicalTrials.gov

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