Status:
COMPLETED
RCT Comparing Robotically-Assisted vs. Manually-Executed Total Knee Arthroplasties
Lead Sponsor:
Mayo Clinic
Conditions:
Osteoarthritis
Eligibility:
All Genders
20-100 years
Phase:
NA
Brief Summary
This study will explore if there are any difference in functional outcomes between two different surgical procedures for total knee replacement: robot-assisted versus manually-executed total knee arth...
Detailed Description
Although total knee arthroplasty (TKA) is an effective treatment for end-stage knee arthritis, improvements in surgical technique remain a necessity. Contemporary designs have bolstered durability, bu...
Eligibility Criteria
Inclusion
- Include all patients who are surgical candidates for primary TKA with unilateral osteoarthritis
- All eligible male or female patients between the ages of 20 years to 100 years old
- All included study participants must be able to give an informed consent.
Exclusion
- Significant femoral or tibial deformity due to congenital or traumatic etiologies, inflammatory arthritis, post-septic arthritis, osteomyelitis, prior infection of knee joint, osteoporosis, dislocated or fragmented patella
- The presence of infections, highly communicable diseases (e.g. AIDS), active tuberculosis, venereal disease, hepatitis.
- Significant neurological or musculoskeletal disorders or disease that may adversely affect normal gait or weight bearing.
- Presence of previous prosthetic knee replacement devices (of any type)
- Metastatic disease
- Psychiatric illness
- Drug or alcohol abuse
- Body mass index (BMI) \> 40 kg/m2
Key Trial Info
Start Date :
March 16 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 13 2025
Estimated Enrollment :
152 Patients enrolled
Trial Details
Trial ID
NCT03482349
Start Date
March 16 2018
End Date
March 13 2025
Last Update
March 14 2025
Active Locations (3)
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1
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
2
Mayo Clinic Florida
Jacksonville, Florida, United States, 32224
3
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905