Robotic- and orthosensor-assisted versus manual (ROAM) total knee replacement: a study protocol for a randomised...

Area of Science:

• Orthopedic Surgery
• Biomedical Engineering
• Health Economics

Background:

• Robotic-arm-assisted knee arthroplasty offers improved accuracy over manual methods.
• The benefit of adding an intra-articular sensor (Verasense™) for intraoperative balancing in total knee replacement (TKR) is unknown.
• Current research aims to evaluate the efficacy and cost-effectiveness of robotic-assisted TKR with Verasense™.

Purpose of the Study:

• To compare functional outcomes between manual TKR and robotic-arm-assisted TKR with Verasense™.
• To assess secondary outcomes including knee function, joint awareness, satisfaction, pain, and quality of life.
• To evaluate the cost-effectiveness of robotic-assisted TKR with Verasense™ compared to standard TKR.

Main Methods:

• A randomized controlled trial involving 90 patients with end-stage knee osteoarthritis undergoing primary TKR.
• Patients were randomized 1:1 to manual TKR or robotic-arm-assisted TKR with Verasense™.
• Primary outcome is functional improvement at 6 months; secondary outcomes include various patient-reported measures and cost-effectiveness.

Main Results:

• This section is not available in the provided abstract as the study is ongoing or results are not yet published.
• Further analysis will compare functional improvement, knee-specific function, joint awareness, patient satisfaction, pain, stiffness, quality of life, cost-effectiveness, and gait patterns.
• The study will determine if robotic-assisted surgery with Verasense™ leads to superior outcomes compared to standard manual techniques.

Conclusions:

• The study will determine if robotic-arm-assisted surgery with Verasense™ improves TKR outcomes compared to standard manual jig-based systems.
• Primary assessment will be based on knee-specific function.
• Cost-effectiveness of the technology will also be evaluated.