Statistical analysis plan for the Robotic-Assisted Surgery and Kinematic ALignment in total knee arthroplasty...

Area of Science:

• Orthopedic Surgery
• Surgical Technology
• Clinical Trials

Background:

• Uncertainty exists regarding the superiority of robotic-assisted surgery (RAS) and kinematic alignment (KA) in improving total knee arthroplasty (TKA) outcomes.
• The Robotic-Assisted Surgery and Kinematic ALignment in TKA (RASKAL) trial is designed to address this uncertainty.
• Current comparative data between RAS/KA and conventional methods like computer-assisted surgery (CAS) and mechanical alignment (MA) are limited.

Purpose of the Study:

• To statistically analyze the RASKAL trial data, ensuring transparency and minimizing bias.
• To assess the effectiveness of RAS and KA, individually or combined, in enhancing clinical, operative, functional, radiological, and survivorship outcomes in TKA patients.
• To provide a robust statistical analysis plan (SAP) that guides the interpretation of trial results.

Main Methods:

• A registry-nested, multicenter, randomized, blinded, 2x2 factorial trial involving approximately 300 TKA patients.
• The statistical analysis plan (SAP) pre-specifies the analysis of primary and secondary outcomes, including handling of protocol deviations, missing data, and withdrawals.
• Primary outcome: knee-specific function (Knee injury and Osteoarthritis Outcome Score-12) comparing RAS to CAS and KA to MA up to one year postoperatively, analyzed via modified intention-to-treat.

Main Results:

• The primary outcome analysis will compare knee function scores between robotic-assisted surgery (RAS) and computer-assisted surgery (CAS).
• Secondary analyses will evaluate kinematic alignment (KA) against mechanical alignment (MA) for knee function.
• A comprehensive assessment of various secondary outcomes including patient-reported measures, recovery, operative efficiency, radiological accuracy, implant survival, and cost-effectiveness is planned.

Conclusions:

• The RASKAL trial's statistical analysis plan is crucial for transparently evaluating the effectiveness of RAS and KA in TKA.
• The findings will elucidate whether advanced techniques like RAS and KA offer superior outcomes compared to conventional CAS and MA.
• This study aims to bolster the internal validity of TKA research by minimizing analytical bias.