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

Mayo Clinic

Status: Completed

Conditions: Osteoarthritis

Treatments: Procedure: Total Knee Robotically-Assisted

Study type: Interventional

Funder types: Other

Identifiers

NCT03482349

17-002188

Details and patient eligibility

About

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.

Full 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, 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.

Enrollment: 152 patients

Sex: All

Ages: 20 to 100 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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152 participants in 2 patient groups

Total Knee Robotically-Assisted

Experimental group

Description:

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.

Treatment:

Procedure: Total Knee Robotically-Assisted

Total Knee Manual-Executed by Surgeon

No Intervention group

Description:

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.