Your session is about to expire
← Back to Search
Hip Implant
Robotic-Assisted Surgery for Hip Conditions
N/A
Recruiting
Research Sponsored by Zimmer Biomet
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 18 - 80 years
Be older than 18 years old
Must not have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial will test how well a robotic-assisted system (ROSA® Hip System) can accurately place a hip implant in multiple medical centers.
Who is the study for?
This trial is for adults aged 18-80 with a BMI ≤40 kg/m2 who need a hip replacement due to conditions like osteoarthritis or avascular necrosis. Candidates must be suitable for the ROSA Hip System and able to consent. It's not open to those outside this age range, with higher BMI, or contraindications.
What is being tested?
The study tests the accuracy of hip implant placement using the ROSA® Hip System robot-assisted surgery. Participants will receive one of several specific hip implants (G7 Acetabular System, Taperloc Complete, Avenir Systems) through an anterior approach.
What are the potential side effects?
While specific side effects are not listed here, typical risks associated with hip replacement surgery may include pain at the site, infection risk, bleeding complications, blood clots in legs or lungs and possible damage to surrounding tissues.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 80 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am at high risk for dislocation due to a long spinal fusion or a neuromuscular disorder.
Select...
I have a joint condition that is not osteoarthritis.
Select...
I have not had both hip replacements at the same time or two hip surgeries within 6 months.
Select...
I do not have any ongoing infections, sepsis, or bone infections.
Select...
I have had surgery before that involved placing metal in my hip area.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Accuracy of implant position
Secondary study objectives
Clinical performance will be assessed by testing leg length discrepancy.
Clinical performance will be assessed with evaluation of range of motion.
Clinical performance will be assessed with evaluation of stability using the Trendelenburg test.
+7 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Robotic-Assisted THAExperimental Treatment1 Intervention
Consecutive participants will receive THA via the ROSA Hip System.
Find a Location
Who is running the clinical trial?
Zimmer BiometLead Sponsor
378 Previous Clinical Trials
68,003 Total Patients Enrolled
137 Trials studying Osteoarthritis
34,566 Patients Enrolled for Osteoarthritis
Hillary OverholserStudy DirectorZimmer Biomet
12 Previous Clinical Trials
3,113 Total Patients Enrolled
9 Trials studying Osteoarthritis
2,410 Patients Enrolled for Osteoarthritis