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

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