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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Osteoarthritis

Intervention / Treatment
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* Procedure: Total Knee Robotically-Assisted


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Total Knee Robotically-Assisted<br>The intervention is then performed with a new device and surgical procedure. At first the femur and the tibia are fixed to the operating table with a special clamp and the knee bones are exposed with the standard technique; then the surgeon digitizes the shape of the joint and the computer transfers the planned surgical strategy to a dedicated surgical robot. Resections are performed by the surgeon on a constrained guide held by the robot. | Procedure: Total Knee Robotically-Assisted<br>* The surgeon digitizes the shape of the joint and the computer transfers the planned surgical strategy to a dedicated surgical robot. Resections are performed by the surgeon on a constrained guide held by the robot.<br>|
| No Intervention: Total Knee Manual-Executed by Surgeon<br>Your orthopaedic surgeon will remove the damaged cartilage and bone, and then position the new metal and plastic implants to restore the alignment and function of your knee. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiographic Parameters | Knee radiographs including an anteroposterior (AP) view and true lateral view, plus a patellar view | 1 year |