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
Autor: | H. W. J. Koot, Jan H. Waarsing, Max Reijman, Pieter K. Bos, Jan A N Verhaar, M. C. Koper, E. M. van Es, S. B. Keizer, F. C. van Biezen, I. Jansen |
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Přispěvatelé: | Orthopedics and Sports Medicine |
Rok vydání: | 2019 |
Předmět: |
Adult
Male medicine.medical_specialty lcsh:Diseases of the musculoskeletal system Visual analogue scale Arthroplasty Replacement Hip medicine.medical_treatment Osteoarthritis Hip law.invention 03 medical and health sciences 0302 clinical medicine Rheumatology Randomized controlled trial law medicine Humans Single-Blind Method Orthopedics and Sports Medicine Femur Patient Reported Outcome Measures Postoperative Period 030212 general & internal medicine Computer-assisted surgery Hip surgery 030222 orthopedics business.industry Middle Aged Arthroplasty Hip resurfacing Surgery Radiography Surgery Computer-Assisted Harris Hip Score Orthopedic surgery Female Hip Prosthesis lcsh:RC925-935 business Research Article Follow-Up Studies |
Zdroj: | BMC Musculoskeletal Disorders, Vol 20, Iss 1, Pp 1-9 (2019) BMC Musculoskeletal Disorders, 20(1). BioMed Central Ltd. BMC Musculoskeletal Disorders |
ISSN: | 1471-2474 |
Popis: | Background Computer 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. Methods This 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. Results A 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. Conclusion Our 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 registration This trial is registered at ClinicalTrails.gov (https://clinicaltrials.gov/) on the 25th of October 2006: NCT00391937. Level of incidence Level IIb, multicenter randomized controlled trial. |
Databáze: | OpenAIRE |
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