Post-Market Study of Robotic-Arm Assisted Total Knee Arthroplasty
Not Applicable
- Conditions
- Osteoarthritis, Knee
- Registration Number
- NCT03106558
- Lead Sponsor
- Rothman Institute Orthopaedics
- Brief Summary
This is an early user evaluation of the robotic-assisted total knee arthroplasty platform. The objective of this surgeon group is to capture data on the defined objectives and provide Stryker with feedback.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 400
Inclusion Criteria
- Patient requires primary total knee surgery
- Patient is willing and able to comply with postoperative follow-up requirements and self evaluations
- Patient is willing to sign an IRB approved informed consent
- Patient is at least 18 years of age
Exclusion Criteria
- Patient has a BMI > 50
- Patient is skeletally immature
- Patient has an active infection or suspected infection in or about the joint
- Bone stock that is inadequate to support fixation of the prosthesis
- Neuromuscular disorders, muscular atrophy or vascular deficiency in the affected limb rendering the procedure unjustified.
- Patients with mental or neurological conditions which may be incapable of following instructions.
- Blood supply limitations
- Collateral ligament insufficiency.
- Patients with prior HTOs or Unis.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Primary Outcome Measures
Name Time Method Component alignment 6 weeks post knee arthroplasty CT scan measurement
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the clinical outcomes of robotic-arm assisted TKA in osteoarthritis patients compared to conventional TKA?
How does robotic-arm assistance improve surgical precision in knee arthroplasty for osteoarthritis?
What are the long-term complications of robotic-arm assisted knee arthroplasty in the post-market setting?
Are there specific biomarkers that predict better outcomes with robotic-arm assisted knee surgery?
What is the comparative effectiveness of Stryker's robotic-arm system versus other orthopedic surgical robots in TKA?
Trial Locations
- Locations (3)
Athens Orthopedic Clinic
🇺🇸Athens, Georgia, United States
Rothman Institute
🇺🇸Philadelphia, Pennsylvania, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Athens Orthopedic Clinic🇺🇸Athens, Georgia, United States