Outcome after polyaxial locking plate osteosynthesis in proximal tibia fractures: a prospective clinical trial

Dominik Völk, Markus Neumaier, Heike Einhellig, Peter Biberthaler, Marc Hanschen, Dominik Völk, Markus Neumaier, Heike Einhellig, Peter Biberthaler, Marc Hanschen

Abstract

Background: The aim of this study was to evaluate the clinical and/or radiologic outcome using different polyaxial locking plates for the treatment of proximal tibia fractures, the Non-Contact-Briding plate (NCB-PT®) by Zimmer or the Variable Angle Locking Compression Plate (VA-LCP®) by Synthes.

Methods: This study enrolled 28 patients with proximal tibia fractures (AO/ OTA 41 B-C) and indication for locking plate osteosynthesis. All patients were treated with a polyaxial locking plate system. Depending on the fracture morphology, patients were either treated with a NCB-PT® or VA-LCP®. The implant was chosen according to the surgeon's experience and preference, in case of a higher degree of comminution the tendency was observed to use the NCB-PT® plate. After a time interval of 12 months postoperative we conducted clinical (e.g. range of motion, the Rasmussen score) and radiological (e.g. primary/secondary loss of reduction) follow-ups.

Results: Patients provided with the NCB-PT® (9 patients) showed longer operation time, use of longer implants, longer interval from injury to surgery and lower clinical scores after the 12 months follow-up compared with the VA-LCP® group (19 patients). Interestingly, the results showed no significant differences regarding the clinical and radiologic outcome.

Conclusions: The small number of patients as well as the heterogeneity of fractures constitute a limitation of this study. Nevertheless, the differentiated use of implants is associated with comparable clinical and radiological outcomes. This trial emphasizes the need for further prospective randomised trials with higher patient numbers.

Trial registration: Retrospectively registered 21.12.2020. Registration number NCT04680247 .

Keywords: Clinical trial; Osteosynthesis; Outcome; Polyaxial locking plate; Proximal tibia fracture.

Conflict of interest statement

This report includes experimental work performed by DV in fulfilment of his doctoral thesis requirements. PB is a surgical instructor in AO courses on the VA-LCP® as well as for the Zimmer institute on the NCB-PT®-system. MH is surgical instructor for Orthofix Srl and BoneSupport, none related to this study.

Apart from the competing interests mentioned above, there are no further competing interests for any of the other authors.

Figures

Fig. 1
Fig. 1
This figure shows an exemplary case of a 64-year old patient treated with a NCB-PT® system. The patient suffered from a AO type 41-C proximal tibia fracture (a-b) after a skiing accident. Initial fixation with an external fixator allowed the soft tissue to consolidate. Due to soft tissue concerns, a staged procedure was chosen for definitive reconstruction. In the first step we conducted a plate osteosynthesis after reduction from posteromedial with a Synthes LCP and the patient in prone position. For the second step we performed a standard anterolateral approach. After a horizontal arthrotomy and visualisation of the entire lateral plateau we elevated the central indented fragment and supported it with an allogeneic cancellous bone graft. After reaching a satisfactory reduction of the lateral compartment we inserted a 7-hole NCB-PT® plate as well as two proximal 4.0 mm lag screws. In a final step we performed a refixation of the tibial tuberosity with two 4.0 mm lag screws The presented images show the postoperative radiologic controls after the final surgery (c) and the image of our radiologic follow-up one year after surgery for NCB-PT® patients (d)
Fig. 2
Fig. 2
The second presented case is a 60-year old patient with an AO type 41-C proximal tibia fracture (a-b) after a fall from under 2 m. Due to soft tissue concerns, a staged procedure was chosen for definitive reconstruction. First, we performed a posteromedial approach. After reduction and temporary K-wire fixation we inserted a Synthes LCP plate for posteromedial osteosynthesis. In the same surgery, we conducted a standard anterolateral approach and horizontal arthrotomy. The main posterolateral fragment was reduced until we reached a stepless result. After insertion of an allogeneic cancellous bone graft, we preformed the fragment fixation with a 4-hole VA-LCP®. Following further consolidation of the soft tissue, we conducted an arthroscopy of the knee and screw osteosynthesis of the eminentia intercondylaris. The images show the postoperative radiologic controls after the final surgery (c) and the image of our radiologic follow-up one year after surgery for VA-LCP® patients (d)
Fig. 3
Fig. 3
Analysing the intraoperative data between the patients treated with a VA-LCP® or NCB-PT® we could determine a significant difference regarding the mean operation time (panel a) and the interval from injury to surgery (panel b). As a result of the heterogeneity of fracture types both proofed to be statistically significant (operation time, p-value 0.0335; injury to surgery interval, p-value 0.0004)
Fig. 4
Fig. 4
In order to reach a comprehensive analysis of the clinical outcome we used five different scoring systems. Among those were the Tegner score (panel a) and Oxford knee score (panel b). Each one of the scores was evaluated by patients’ self-assessment survey to reflect the situation before the accident and at our 12 months follow-up. In our analysis patients tended to reach comparable functional scores at the 12 month follow-up

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