Inflammatory Response Conventional Total Knee Replacement Versus Mako Total Knee Replacement
Condition: Knee Osteoarthritis; Arthritis; Surgery
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      Total knee Arthroplasty (TKA) is a highly effective treatment for knee osteoarthritis. Mid-
      to long-term follow-up studies have shown good clinical outcomes following TKA; despite these
      results, there is a high incidence of patient dissatisfaction; 20% of patients reporting
      dissatisfaction in otherwise uncomplicated procedures.

      One reason for early dissatisfaction may be the trauma of surgery may lead to localised and
      systemic inflammatory responses that impair postoperative clinical recovery; this in turn
      influences long-term functional outcomes. Surgical techniques that limit the insult of
      surgery and help to restore the patient's native knee anatomy and kinematics may help to
      improve clinical outcomes, functional recovery, and patient satisfaction.

      The technical objectives of surgery are to restore limb alignment, preserve the joint line,
      balance flexion and extension gaps, and maintain the normal Q angle for optimal patella
      tracking. Compromise to the periarticular soft tissue structures may compromise postoperative
      clinical and functional recovery, reduce stability, and decrease implant survivorship. In
      conventional jig-based (CO) TKA, bone cuts are most commonly performed using measured
      resection or gap balancing. The manual error associated with inadvertent soft tissue release
      during preparation for implantation or tissue damage from the saw blades is an accepted part
      of the procedure.

      The evolution of surgical technology has led to the development of robotic-arm assisted TKA,
      which uses three dimensional images of the patient's native knee anatomy to guide bone
      resection and optimise implant positioning. The second-generation RIO Robotic Arm Interactive
      Orthopaedic system (Mako surgical) uses preoperative computerised tomography scans to build a
      computer-aided design (CAD) model of the patient's knee joint. The Mako robotic software
      processes this information to calculate the volume of bone requiring resection and creates a
      three-dimensional haptic window for the RIO robotic arm to resect.

      In short, the robotic technology in TKA allows execution of the preoperative surgical plan
      without undue soft tissue release, inadvertent trauma from power tools, and minimal trauma to
      bone surfaces. Conceptually, this Mako TKA should have reduced soft tissue trauma and
      inflammatory response as assessed with inflammatory cytokines compared to CO TKA.

      The overall aim of this single centre, prospective randomised controlled trial is to
      determine differences in the inflammatory response between CO TKA and Mako TKA.

      A comprehensive range of local and systemic biochemical markers, thermal response, and
      macroscopic soft tissue injury outcomes between the two groups will be recorded and
      correlated to clinical and functional outcomes over 2-year postoperative. Patients undergoing
      CO TKA will form the control group and those undergoing Mako TKA will form the investigation
      group.
    


Intervention name(s): Total Knee Arthroplasty
Intervention type(s): Device
Intervention description(s): Surgical implantation of prosthetic knee using robotic-arm assist
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: biomechanical; inflammation; mako robot; makoplasty; soft tissue injury; total knee arthroplasty; total knee replacement; thermal