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Mono- versus polyaxial locking plates in distal femur fractures: a prospective randomized multicentre clinical trial
Authors:Marc Hanschen  Ina M. Aschenbrenner  Kai Fehske  Sonja Kirchhoff  Leonhard Keil  Boris M. Holzapfel  Sebastian Winkler  Bernd Fuechtmeier  Rainer Neugebauer  Sven Luehrs  Ulrich Liener  Peter Biberthaler
Affiliation:1. Department of Trauma Surgery, Klinikum rechts der Isar, Technical University Munich, Ismaninger Strasse 22, 81675, Munich, Germany
2. Department of Trauma, Hand, Plastic and Reconstructive Surgery, University Clinics of Wuerzburg, Oberduerrbacher Str. 6, 97080, Wuerzburg, Germany
3. Department of Clinical Radiology, Ludwig-Maximilians-University, Nussbaumstr. 20, 80336, Munich, Germany
4. Department of Trauma and Orthopaedic Surgery, Ludwig-Maximilians-University, Nussbaumstr. 20, 80336, Munich, Germany
5. Department of Trauma and Orthopaedic Surgery, Hospital Barmherzige Brueder, Pruefeninger Str. 86, 93049, Regensburg, Germany
6. Department of Trauma, Hand, Plastic and Reconstructive Surgery, University of Ulm, Albert-Einstein-Allee 23, 89081, Ulm, Germany
Abstract:

Purpose

Treatment of complex fractures of the distal femur utilizing monoaxial locking plates (e.g. Less Invasive Stabilisation System, LISS®, Synthes) is considered to be superior to conventional plating systems. Due to the limitation that the thread forces the screw into pre-determined positions, modifications have been made to allow screw positioning within a range of 30° (Non Contact Bridging, NCB®-DF, Zimmer). For the first time, this multicenter prospective randomized clinical trial (RCT) investigates the outcome of LISS® vs. NCB®-DF treatment following complex fractures of the distal femur.

Methods

Since June 2008, 27 patients with a fracture of the distal femur (AO ASIF 33-A-C and periprosthetic fractures) were enrolled in this study by four university trauma centres in southern Germany. Clinical (e.g. range of motion, Oxford knee score, Tegner score) and radiological (e.g. axis deviation, secondary loss of realignment) follow-ups were conducted one and six weeks, as well as three, six, and 12 months after the operation.

Results

This study comprises data of 27 patients (8 male, 19 female; 15 NCB®-DF, 12 LISS®). Polyaxial osteosynthesis using the NCB® system tended to result in better functional knee scores and a higher range of motion. Interestingly, fracture union tended to be more rapid using the polyaxial plating system.

Conclusions

We present the analysis of a multicenter prospective RCT to compare the monoaxial LISS® vs. the polyaxial NCB®-DF treatment following complex fractures of the distal femur. NCB®-DF treatment tended to result in better functional and radiological outcomes than LISS® treatment.

Level of Evidence

Level I
Keywords:Monoaxial plating   Polyaxial plating   Locked plate osteosynthesis   Distal femur fracture   Randomized clinical trial
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