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.
Highlights
Computer Assisted Surgery (CAS) has proven to improve the accuracy in several orthopedic procedures
During the trial period, a total of 125 patients (133 hips) were included, 67 hips were randomized to the conventional group and 66 hips to the CAS group
A total of 11 randomized patients were excluded due to primary missing data and loss of follow up, five patients in the conventional group and six patients in the CAS group. These patients showed no difference in baseline characteristics. Patients in both groups were similar, except for Body Mass Index (BMI), which was significantly higher in the CAS group (26.9 versus 25.5, p = 0.003), which can be explained by a higher body weight (Table 1)
Summary
Computer Assisted Surgery (CAS) has proven to improve the accuracy in several orthopedic procedures We used this technique to evaluate femoral component positioning in Hip Resurfacing Arthroplasty (HRA). We hypothesized that the use of CAS optimizes the position of the femoral component and improves PROMs. Hip Resurfacing Arthroplasty (HRA) is still considered a viable treatment option for young and active patients with end-stage osteoarthritis of the hip. There have been a high number of early failures and a high revision rates [4,5,6,7,8] This led to a recall of several MoM hip bearings, a more frequent follow-up of patients, and to a reduced use of HRA’s worldwide. For some implants and patient categories equal to Total Hip Arthroplasty [9, 10]
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