Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
NA
12 participants
INTERVENTIONAL
2024-06-05
2024-12-20
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Outcomes of Robotic Total Hip Arthroplasty
NCT01672320
Prospective Clinical Follow-up of the Echo Bi-Metric Microplasty Stem for Total Hip Arthroplasty
NCT04326010
Robot Assisted Total Hip Arthroplasties
NCT05947734
Study to Evaluate the Safety and Efficacy of OR3O™ Dual Mobility System vs. Conventional Single Bearing Design Total Hip System
NCT04941729
A Multi-centre Study to Assess the Long-term Performance of the Summit™ Hip in Primary Total Hip Replacement
NCT00208390
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Robotic-Assisted THA
Consecutive participants will receive THA via the ROSA Hip System.
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
18 Years
80 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Zimmer Biomet
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Hillary Overholser
Role: STUDY_DIRECTOR
Zimmer Biomet
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The Mayo Clinic Jacksonville
Jacksonville, Florida, United States
Mosaic Life Care
Saint Joseph, Missouri, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CMU2021-26TDS
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.