Focus of the Report: The focus of this Health Technology Assessment (HTA) is to evaluate the effectiveness and safety of the Mako Robotic-Arm assisted total knee arthroplasty (RATKA) system (Stryker) compared with manual total knee arthroplasty (TKA) for the treatment of knee osteoarthritis (KOA).

Technology Description: The Mako RATKA system is a semiactive tactile robotic system, meaning that the robotic arm is under direct control of a surgeon who receives real-time tactile feedback during the TKA procedure. RATKA is thought to improve prosthesis position and alignment as well as to increase preservation of soft tissue, which may lead to improved outcomes and prolonged implant survival.

Controversy: TKA is technically challenging and demands precise implant alignment and soft tissue balance for optimal knee function. Failure of manual TKA is predominantly caused by surgical error. Mako RATKA utilizes computerized surgical planning and navigation to enable more precise placement of prosthetic implants. However, robotic systems are costly, and Mako RATKA requires a preoperative computed tomography (CT) scan. Mako RATKA also involves a learning curve for this complex procedure. It is unknown whether there is a clinically significant benefit of using RATKA over conventional manual TKA, especially over the long term.

Key Questions:

  1. Is Mako Robotic-Arm (Stryker) (RATKA) effective for KOA?

  2. How does Mako RATKA compare with manual TKA for KOA?

  3. Is Mako RATKA in patients with KOA safe?

  4. Have definitive patient selection criteria been identified for Mako RATKA for KOA?

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