title: Poor relation between biomechanical and clinical studies for the proximal femoral locking compression plate.
abstract: Background and purpose - The proximal femur locking compression plate (PF-LCP) is a new concept in the treatment of hip fractures. When releasing new implants onto the market, biomechanical studies are conducted to evaluate performance of the implant. We investigated the relation between biomechanical and clinical studies on PF-LCP. Methods - A systematic literature search of relevant biomechanical and clinical studies was conducted in PubMed on December 1, 2015. 7 biomechanical studies and 15 clinical studies were included. Results - Even though the biomechanical studies showed equivalent or higher failure loads for femoral neck fracture, the clinical results were far worse, with a 37% complication rate. There were no biomechanical studies on pertrochanteric fractures. Biomechanical studies on subtrochanteric fractures showed that PF-LCP had a lower failure load than with proximal femoral nail, but higher than with angled blade plate. 4 clinical studies had complication rates less than 8% and 9 studies had complication rates between 15% and 53%. Interpretation - There was no clear relation between biomechanical and clinical studies. Biomechanical studies are generally inherently different from clinical studies, as they examine the best possible theoretical use of the implant without considering the long-term outcome in a clinical setting. Properly designed clinical studies are mandatory when introducing new implants, and they cannot be replaced by biomechanical studies.
authors.affiliation: a Department of Orthopedic Surgery and Traumatology , Odense University Hospital , Odense.|b Department of Clinical Research , University of Southern Denmark , Odense , Denmark.
authors.forename: Bjarke
authors.initials: B
authors.lastname: Viberg
authors.affiliation: a Department of Orthopedic Surgery and Traumatology , Odense University Hospital , Odense.|b Department of Clinical Research , University of Southern Denmark , Odense , Denmark.
authors.forename: Katrine M V
authors.initials: KMV
authors.lastname: Rasmussen
authors.affiliation: a Department of Orthopedic Surgery and Traumatology , Odense University Hospital , Odense.|b Department of Clinical Research , University of Southern Denmark , Odense , Denmark.
authors.forename: Søren
authors.initials: S
authors.lastname: Overgaard
authors.affiliation: c Department of Orthopedics , Skåne University Hospital Malmö, Lund University , Sweden.
authors.forename: Cecilia
authors.initials: C
authors.lastname: Rogmark
mesh_terms: D001696:Biomechanical Phenomena; D001860:Bone Plates / Q000009:adverse effects; D005265:Femoral Neck Fractures / Q000601:surgery; D006620:Hip Fractures / Q000601:surgery*; D006801:Humans; D011475:Prosthesis Failure; D016474:Weight-Bearing