Health Problem: Osteoarthritis (OA) is a degenerative disorder affecting more than 30 million adults in the United States and is the leading cause of disability in older adults. OA is characterized by the breakdown of joint cartilage with involvement of the subchondral bone and synovium. Symptoms of OA of the knee include joint pain, stiffness, and swelling, which ultimately impact joint function and can lead to disability. The treatment goals for OA are pain relief, maintenance of joint flexibility, and optimizing joint function. Knee OA symptoms that are recalcitrant to conservative measures may be treated by intra-articular injections or surgically by arthroscopy, osteotomy, or arthroplasty.

Technology Description: The Mako Robotic-Arm system is a semi-active tactile robotic system, meaning that the robotic arm is under direct control of the surgeon who receives real-time tactile feedback during partial knee arthroplasty (PKA). The Mako Robotic-Arm system also provides information on limb alignment and soft tissue balance so that the surgeon can properly align the Mako prosthetic implant and select the appropriate polyethylene insert.

Controversy: PKA is technically challenging and demands precise implant alignment and soft tissue balance for optimal knee function. Failure of manual PKA is predominantly caused by surgical error. Mako Robotic-Arm Assisted PKA usescomputer surgical planning and navigation to enable more precise implantation of prosthetic implants. However, robotic systems are costly, and it is unknown whether there is a clinically significant benefit of using robotic-assisted PKA over conventional manual PKA.

Key Questions:

  • Is PKA with the Mako Robotic-Arm Assisted Surgery system effective for treating OA of the knee?
  • How does PKA with the Mako Robotic-Arm Assisted Surgery system compare with conventional partial knee arthroplasty for OA of the knee?
  • Is PKA with the Mako Robotic-Arm Assisted Surgery system safe?
  • Have definitive patient selection criteria been identified for treatment of OA with the Mako Robotic-Arm Assisted Surgery system?

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