No added value for Computer-Assisted surgery to improve femoral component positioning and Patient Reported Outcomes in Hip Resurfacing Arthroplasty; a multi-center randomized controlled trial

Abstract

BackgroundComputer Assisted Surgery (CAS) has proven to improve the accuracy in several orthopedic procedures. Therefore we used this technique to evaluate femoral component positioning in Hip Resurfacing Arthroplasty (HRA). The aim of this study was to evaluate imageless CAS compared to manually implanted femoral components and subsequently evaluates Patient Related Outcome Measures (PROMs). We hypothesized that the use of CAS optimizes the position of the femoral component and improves PROMs.MethodsThis is a multicenter, single-blinded, randomized, controlled trial of two groups. In the CAS group guiding of the femoral component was done with imageless navigation. In the Conventional (control) group the femoral component was placed manually according to the preplanned position. The primary outcome measure consists of a maximum of 3 degrees difference between the postoperative Stem Shaft Angle (SSA) and preplanned SSA. Secondary outcome measures consist of the Hip disability and Osteoarthritis Outcome Scale (HOOS), the Harris Hip Score (HHS) and Visual Analogue Scale (VAS) pain score.ResultsA total of 122 patients were randomized, 61 in the CAS group and 61 in the conventional group. There was no significant differences in accuracy of femoral implant position. The mean difference between the postoperative- and preplanned SSA was − 2.26 and − 1.75 degrees (more varus) respectively in the CAS and Conventional group. After surgery both groups show significant improvement in all PROMs compared to the baseline measurements, with no significant differences between the groups.ConclusionOur cohort indicates no benefit for the use of CAS in accuracy of placement of the femoral component in HRA compared to manual implantation. There are no clinical differences in PROMs after 1 year follow up. This study showed no added value and no justification for the use of CAS in femoral component positioning in HRA.Trial registrationThis trial is registered at ClinicalTrails.gov (https://clinicaltrials.gov/) on the 25th of October 2006: NCT00391937.Level of incidenceLevel IIb, multicenter randomized controlled trial.

Accuracy of Positioning and Risk Factors for Malpositioning Custom-Made Femoral Stems in Total Hip Arthroplasty—A Retrospective Multicenter Analysis

“…Concerning the stem, there is conflicting evidence on whether the planned position can be achieved more accurately with navigation tools or robots. Koper et al in 2019 published their multicenter randomized controlled trial on the value of navigation in hip resurfacing using the BrainLab Ci™ ASR System 1.0 (BrainLAB AG, Feldkirchen, Germany) [ 40 ]. Compared to conventional implantation, there was no significant difference in the accuracy of the placement of the femoral component.…”

Are serum cobalt and chromium levels predictors for patient-reported outcome measures in the ASR hip resurfacing arthroplasty?

“…This is a retrospective evaluation of data from a prospectively collected database of all patients from our hospital who participated in an earlier published multicentre RCT. 32 The trial compared computer-assisted surgery (CAS) to conventional surgery in patients who received an ASR-HRA, started in October 2006 and discontinued in January 2010 due to the worldwide ASR-HRA recall. Operations were performed using a standard posterolateral approach and the ASR-HRAs were either placed according with the standard manual device or by using CAS.…”

“…Two authors (MK, EMvE) independently calculated these angles in a double-blinded manner (duplicate measurements without patient details) using GeoGebra software (International GeoGebra Institute and GeoGebra, Austria). 32 For the measurements of the inclination angle and SSA, the intraobserver and interobserver reliability were evaluated using the intraclass correlation coefficient (ICC). A two-way mixed model was used with absolute agreement and a confidence interval (CI) of 95%.…”

“…Over a period of ten years, we followed a cohort of patients, recruited in a previously conducted randomized controlled trial (RCT), with regular serum Co and Cr measurements and PROM assessments. 32 These unique long-term follow-up data enable us to evaluate the relationship between increasing serum metal ion levels and PROM outcomes. The primary aim of this study was to evaluate a increasing serum Co or Cr levels as a predictor of a deteriorating Harris Hip Score (HHS) 33 and Hip disability and Osteoarthritis Outcome Score (HOOS) 34 in patients with an ASR-HRA.…”