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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Osteoarthritis, Hip
- Sponsor
- Zimmer Biomet
- Enrollment
- 12
- Locations
- 2
- Primary Endpoint
- Accuracy of implant position
- Status
- Terminated
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Accuracy of implant position
Time Frame: 90 days
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.
Secondary Outcomes
- Evaluation of Patient safety(24 months)
- Numeric Pain Rating Scale (NPRS)(24 months)
- Patient Reported Outcome Measure (Oxford Hip Score)(24 months)
- Clinical performance will be assessed with evaluation of stability using the Trendelenburg test.(24 months)
- Subject Satisfaction(24 months)
- Clinical performance will be assessed with evaluation of range of motion.(24 months)
- Clinical performance will be assessed by testing leg length discrepancy.(24 months)
- Physician Radiographic Assessment of Acetabular Cup(2 Years)
- Physician Radiographic Assessment of Femoral and Global Offset and Leg Length Discrepancy(2 Years)
- Physician Radiographic Assessment of Significant Radiographic Findings(2 Years)