ROSA® Hip System THA PMCF

Not Applicable

Terminated

• Conditions: Osteoarthritis, Hip; Avascular Necrosis of Hip

• Registration Number: NCT05497206
• Lead Sponsor: Zimmer Biomet

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.

Study Timeline

• Study First Submitted: 2022-02-23
• Study First Submitted QC: 2022-08-10
• Study First Posted: 2022-08-11
• Study Start: 2024-06-05
• Primary Completion: 2024-12-12
• Study Completion: 2024-12-20
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-31
• Last Update Posted: 2025-02-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Accuracy of implant position	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 Outcome Measures

Name	Time	Method
Evaluation of Patient safety	24 months	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.
Numeric Pain Rating Scale (NPRS)	24 months	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
Patient Reported Outcome Measure (Oxford Hip Score)	24 months	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).
Clinical performance will be assessed with evaluation of stability using the Trendelenburg test.	24 months	The test is negative when the hip of the leg that is lifted, will also go up i.e., hiking of hip or the pelvis tilts upwards. The test is positive, when there is a drop of the hip or a downwards tilt of the pelvis. The test is level when the subject presents normal gait and adequate pelvic stability. If the subject is unable to perform the test, this will be noted "unable to perform test".
Subject Satisfaction	24 months	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.
Clinical performance will be assessed with evaluation of range of motion.	24 months	Range of motion will be evaluated in a supine position and assess flexion, abduction (in flexion), adduction (in flexion), external rotation (in extension), and internal rotation (in extension). Range of motion will be measured in degrees.
Clinical performance will be assessed by testing leg length discrepancy.	24 months	This will be assessed by (3) categories (legs equal, right short, left short) and discrepancies will be measured in mm or cm.
Physician Radiographic Assessment of Acetabular Cup	2 Years	Records acetabular cup inclination (degrees), acetabular cup anteversion (degrees)
Physician Radiographic Assessment of Femoral and Global Offset and Leg Length Discrepancy	2 Years	Records femoral offset (mm), global offset (mm), leg length (mm)
Physician Radiographic Assessment of Significant Radiographic Findings	2 Years	Records evidence of fracture (y/n), evidence of acetabular migration (y/n), evidence of heterotopic ossification (y/n), or other significant radiographic findings (including the zone it occurs in)

Trial Locations

Locations (2)

The Mayo Clinic Jacksonville; 🇺🇸 Jacksonville, Florida, United States

Mosaic Life Care; 🇺🇸 Saint Joseph, Missouri, United States