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Short-term safety and efficacy of a novel high tibial osteotomy system: a case controlled study

  • Knee
  • Published:
Knee Surgery, Sports Traumatology, Arthroscopy Aims and scope

A Letter to Editor to this article was published on 31 August 2012

Abstract

Purpose

To evaluate the safety and efficacy of the novel iBalance Medial Opening Wedge High Tibial Osteotomy (HTO) system in executing lower limb realignment in patients with symptomatic varus gonarthrosis.

Methods

A multicentre case series of iBalance medial opening wedge HTO was compared to an historic case-matched control series of HTO’s performed using another implant. Subjects were prospectively observed at 3, 6 and 12 months after surgery. Primary endpoints included the reporting of adverse events, weight-bearing status without pain and radiographic evidence of bony union. Secondary endpoints included maintenance of osteotomy correction angle, patient reported outcome (KOOS and SF-36) and gait analysis.

Results

Thirty-two consecutive patients were included in the iBalance group (mean age 49.7, 30–67; M:F, 20:12), paired with 32 control subjects (49.8, 35–66; 21:11). Three patients (9.4%) in the iBalance group experienced a complication requiring intervention versus one patient (3.1%) in the control group. No statistically significant differences were seen between groups in terms of time to weight bearing, radiographic union, implant stability or patient reported outcome. Gait analysis revealed a statistically significant reduction in knee external adduction moment (P < 0.001).

Conclusions

The iBalance medial opening wedge HTO system has been shown to be a safe, novel implant for use in proximal tibial osteotomy. This study shows that the iBalance medial opening wedge HTO system has an equivalent short-term safety and efficacy profile to the 2nd generation Puddu system.

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Acknowledgments

The authors would like to acknowledge the funding support from iBalance Medical Inc. (Now Arthrex Inc, Naples FL, USA).

Conflict of interest

The principal investigator (RL) received research funding and was a paid consultant for iBalance Medical Inc. None of the other authors have any conflict of interest to disclose.

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Authors and Affiliations

  1. Fowler Kennedy Sport Medicine Clinic, University of Western Ontario, 3M Centre, London, ON, Canada

    Alan Getgood, Brett Collins & Robert Litchfield

  2. Sports Medicine Center CMS, Wawelska 5, Warsaw, Poland

    Konrad Slynarski & Emilia Kurowska

  3. Sydney Orthopaedic Research Institute, Sydney, NSW, Australia

    David Parker

  4. Department of Orthopaedic Surgery, University of Oslo, Oslo, Norway

    Lars Engebretsen

  5. Section of Orthopaedics, University of Manitoba, Pan Am Clinic, Winnipeg, MB, Canada

    Peter B. MacDonald

Authors
  1. Alan Getgood
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  2. Brett Collins
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  3. Konrad Slynarski
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  4. Emilia Kurowska
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  5. David Parker
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  6. Lars Engebretsen
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  7. Peter B. MacDonald
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  8. Robert Litchfield
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Correspondence to Alan Getgood.

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Getgood, A., Collins, B., Slynarski, K. et al. Short-term safety and efficacy of a novel high tibial osteotomy system: a case controlled study. Knee Surg Sports Traumatol Arthrosc 21, 260–269 (2013). https://doi.org/10.1007/s00167-011-1709-4

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  • DOI: https://doi.org/10.1007/s00167-011-1709-4

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