Quality Assessment of Computer-Assisted Navigation Knee Arthroplasty Studies

Area of Science:

• Orthopedic Surgery
• Medical Technology Evaluation
• Clinical Trial Methodology

Background:

• Computer-navigated total knee arthroplasty (TKA) aims to enhance component alignment and reduce complications compared to conventional TKA.
• Existing studies on navigated TKA exhibit variable quality, necessitating a systematic assessment of their methodological rigor.
• This review evaluates the quality of randomized controlled trials (RCTs) comparing computer-navigated and conventional TKA.

Purpose of the Study:

• To systematically assess the methodological quality of RCTs comparing computer-navigated TKA with conventional TKA.
• To identify strengths and weaknesses in the design and reporting of these trials.
• To provide recommendations for improving the quality of future research in navigated TKA.

Main Methods:

• A systematic literature search was performed across PubMed, Embase, and MEDLINE for RCTs on computer-navigated knee arthroplasty.
• 119 RCTs met the inclusion criteria and were assessed using the transformed Detsky index for reporting completeness and the modified Cochrane risk-of-bias tool for methodological rigor.
• Quality assessment focused on reporting standards, biases, randomization, and blinding.

Main Results:

• While 98% of studies showed high reporting quality (mean Detsky score 92%), only 27% had high methodological quality (mean Cochrane risk-of-bias score 6.2).
• Deficiencies were noted in allocation concealment, blinding, and bias mitigation.
• Study quality, particularly risk of bias, improved over time, with variations observed based on trial location and funding source.

Conclusions:

• Randomized controlled trials in computer-navigated TKA have improved in reporting standards but still exhibit significant methodological weaknesses.
• Enhancing randomization, blinding, and sample sizes is crucial for strengthening the validity of future TKA trials.
• Multicenter collaborations, standardized reporting, and transparent industry funding are essential for generating reliable evidence for TKA decision-making.