RCT Comparing Robotically-Assisted vs. Manually-Executed Total Knee Arthroplasties

A Prospective Randomized Clinical Trial (RCT) Comparing Functional and Radiographic Outcomes of Robotically-Assisted vs. Manually-Executed Total Knee Arthroplasties

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 arthroplasty.

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, but longer life expectancies have placed an even greater emphasis on survivorship. Additionally, patient satisfaction remains an issue.

A prospective randomized clinical trial (RCT) is proposed to compare robotically-assisted versus manually executed primary (TKAs). This study is designed to address the major short-term clinically important issues between the two types of procedures with special emphasis on functional outcome. Patients will be randomized to receive either a robotically-assisted or a manually-executed primary TKA.

Inclusion Criteria:

• 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 Criteria:

• 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