Patient-Specific CT-Based Instrumentation versus Conventional Instrumentation in Total Knee Arthroplasty: A Prospective Randomized Controlled Study on Clinical Outcomes and In-Hospital Data

Abstract

Total knee arthroplasty (TKA) is a frequently performed procedure in orthopaedic surgery. Recently, patient-specific instrumentation was introduced to facilitate correct positioning of implants. The aim of this study was to compare the early clinical results of TKA performed with patient-specific CT-based instrumentation and conventional technique. A prospective, randomized controlled trial on 112 patients was performed between January 2011 and December 2011. A group of 112 patients who met the inclusion and exclusion criteria were enrolled in this study and randomly assigned to an experimental or control group. The experimental group comprised 52 patients who received the Signature CT-based implant positioning system, and the control group consisted of 60 patients with conventional instrumentation. Clinical outcomes were evaluated with the KSS scale, WOMAC scale, and VAS scales to assess knee pain severity and patient satisfaction with the surgery. Specified in-hospital data were recorded. Patients were followed up for 12 months. At one year after surgery, there were no statistically significant differences between groups with respect to clinical outcomes and in-hospital data, including operative time, blood loss, hospital length of stay, intraoperative observations, and postoperative complications. Further high-quality investigations of various patient-specific systems and longer follow-up may be helpful in assessing their utility for TKA.

A Meta-analysis of Functional Outcomes in Patient-Specific Instrumented Knee Arthroplasty

“…In total, eight studies [12][13][14][15][16][17][18][19] were included reporting a total of 828 knees (five RCTs [12][13][14][15][16] and three prospective comparative [17][18][19] ). Two series were extracted from the study by Pfitzner et al 14 as this had three arms investigating conventional versus PSI (CT) versus PSI (MRI).…”

“…Maximum postoperative follow-up ranged between 3 months 12-14 in three studies and 2 years in two studies, 17,18 the remaining studies were either 6 15,19 or 12 months. 16 Six studies examined postoperative alignment parameters in addition to functional outcomes. [12][13][14][15]17,19 All eight studies reported postoperative KSS (function), [12][13][14][15][16][17][18][19] and seven studies reported KSS (knee).…”

“…16 Six studies examined postoperative alignment parameters in addition to functional outcomes. [12][13][14][15]17,19 All eight studies reported postoperative KSS (function), [12][13][14][15][16][17][18][19] and seven studies reported KSS (knee). 12,13,[15][16][17][18][19] Three studies reported postoperative OKS, 12,13,18 five documented ROM, [13][14][15]17,18 two reported WOMAC 14,16 or VAS.…”

“…12,13,[15][16][17][18][19] Three studies reported postoperative OKS, 12,13,18 five documented ROM, [13][14][15]17,18 two reported WOMAC 14,16 or VAS. 16,17 Quality Assessment and Risk of Bias…”

“…In this study, we therefore systematically review data from Levels 1 [12][13][14][15] and 2 studies [16][17][18][19] of patient-specific instrumented knee arthroplasty. Meta-analysis methods of published literature data was undertaken to assess whether patient-specific instrumented knee arthroplasty allows a greater range of motion and provides a superior functional outcome to conventional knee prostheses.…”