ROSA® Hip System THA PMCF

NCT05497206 | Terminated FDA Device

• 1 other identifier: CMU2021-26TDS
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

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).

Conditions

Osteoarthritis, Hip; Avascular Necrosis of Hip

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Evaluation of Patient safety

  24 months

• Patient Reported Outcome Measure (Oxford Hip Score)

  24 months

• Numeric Pain Rating Scale (NPRS)

  24 months

• Subject Satisfaction

  24 months

• Clinical performance will be assessed with evaluation of range of motion.

  24 months

Study Arms (1)

Robotic-Assisted THA

EXPERIMENTAL

Consecutive participants will receive THA via the ROSA Hip System.

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

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 System DEVICE

Total Hip Arthroplasty

Robotic-Assisted THA

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 - 80 years
• Body mass index ≤40 (BMI = kg/m2)
• Patient is willing and able to provide informed consent
• Patient qualifies for primary THA, via an anterior approach, due to osteoarthritis or avascular necrosis of the hip based on Investigator's clinical judgment
• Independent of study participation, patient is a candidate and meets the indications and none of the contraindications for use with the ROSA Hip System

You may not qualify if:

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

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (2)

The Mayo Clinic Jacksonville

Jacksonville, Florida, 32224, United States

Location

Mosaic Life Care

Saint Joseph, Missouri, 64507, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Hillary Overholser

  Zimmer Biomet

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2022
• First Posted: August 11, 2022
• Study Start: June 5, 2024
• Primary Completion: December 12, 2024
• Study Completion: December 20, 2024
• Last Updated: February 5, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)