Osteoarthritis, Knee
Conditions
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.
Interventions
DEVICETotal Knee Arthroplasty using Manual Instrumentation
DEVICETotal Knee Arthroplasty using Robotic Arm
Sponsors
Stryker Orthopaedics
Rothman Institute Orthopaedics
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Component alignment | 6 weeks post knee arthroplasty | CT scan measurement |
Countries
United States
Outcome results
None listed