ROSA® Hip System THA PMCF

Osteoarthritis, Hip Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05497206
• Other study ID #: CMU2021-26TDS
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2024
• Est. completion date: December 2026

Study information

• Verified date: March 2024
• Source: Zimmer Biomet
• Contact: Megan McKinnie
• Phone: 1 (919) 381-7091
• Email: megan.mckinnie[@]zimmerbiomet.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: December 2026
• Est. primary completion date: July 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Avascular Necrosis of Hip
• Necrosis
• Osteoarthritis, Hip

Intervention

Device:
• 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 System
Total Hip Arthroplasty

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	90 days
Secondary	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.	24 months
Secondary	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).	24 months
Secondary	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	24 months
Secondary	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.	24 months
Secondary	Clinical performance will be assessed with evaluation of range of motion.	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.	24 months
Secondary	Clinical performance will be assessed with evaluation of stability using the Trendelenburg test.	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".	24 months
Secondary	Clinical performance will be assessed by testing leg length discrepancy.	This will be assessed by (3) categories (legs equal, right short, left short) and discrepancies will be measured in mm or cm.	24 months
Secondary	Physician Radiographic Assessment of Acetabular Cup	Records acetabular cup inclination (degrees), acetabular cup anteversion (degrees)	2 Years
Secondary	Physician Radiographic Assessment of Femoral and Global Offset and Leg Length Discrepancy	Records femoral offset (mm), global offset (mm), leg length (mm)	2 Years
Secondary	Physician Radiographic Assessment of Significant Radiographic Findings	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)	2 Years