Computer-navigated versus conventional total knee arthroplasty: A randomized controlled trial protocol in China

Abstract

Background: The literature lacks studies that confirm whether the improved radiographic alignment that can be achieved with computer-navigated total knee arthroplasty (TKA) improves patients' activities of daily living or the durability of total knee prostheses. Thus, in this protocol, we designed a randomized controlled trial to compare implant alignment, functional scores, and survival of the implant using computer-assisted surgery versus a conventional surgical technique.

Methods: This prospective, blinded randomized controlled trial was conducted at our single hospital. This study was approved by the ethics committee of Jiaxing Second Hospital. The patient inclusion criteria were age 20 to 80 years' old, a body mass index of ≤35 kg/m, and consented for primary knee arthroplasty performed through a medial parapatellar approach by the senior author. We randomized consented study participants on a 1:1 ratio to 1 of 2 study groups using a computer-generated list of random numbers in varying block sizes. The primary outcome in this study was the Knee Injury and Osteoarthritis Outcome Score. Secondary outcomes were the Knee Society Score, Western Ontario and McMaster Universities Osteoarthritis Index, complications, and range of motion together with alignment and rotational positioning of the implant. Statistical significance was defined as a P value of ≤0.05.

Conclusions: Authors hypothesized that computer-assisted surgery in primary TKA improves implant alignment, functional scores, and survival of the implant compared to the conventional technique.

Figure 1

Consolidated Standards of Reporting Trials Statement flow diagram.