OPTY-LINE remote-controlled adjustable intramedullary device implantation in open-wedge high tibial osteotomy: a prospective proof-of-concept pilot and comparison with Tomofix fixed-plate device method

Jonker, Leon, Fallahi, Farshid, Saraswathy, Jayadeep J., Edge, John and Dawson, Matt (2019) OPTY-LINE remote-controlled adjustable intramedullary device implantation in open-wedge high tibial osteotomy: a prospective proof-of-concept pilot and comparison with Tomofix fixed-plate device method. Journal of Orthopaedic Surgery, 27 (3).

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Official URL: https://doi.org/10.1177/2309499019864721

Abstract

Purpose: The objective was to evaluate the clinical and patient-related short- to medium-term performance of the OPTY-LINE nail device for high tibial osteotomy (HTO), comparing a case series of the said device to the established Tomofix fixed-plate device.

Patients and Methods: Males with symptomatic medial compartmental osteoarthritis and no serious (co-morbid) knee pathology were followed up, five Tomofix and six OPTY-LINE patients. Patients underwent computed tomography assessment and completed Knee Injury and Osteoarthritis Outcome score (KOOS) and osteotomy surgery patient satisfaction questionnaires, 3 and 6 months post-surgery. A radiologist impression score and a quantitative digital bone density analysis were performed by two independent radiologists. Mann–Whitney U test was applied for inferential statistical tests.

Results: At 6 months post-surgery, for Tomofix, the median radiologists’ healing impression score was ‘progressive healing’ versus ‘union virtually complete’ for the OPTY-LINE nail; bone healing quotient was 1.30 (standard deviation (SD) 1.74) versus 1.78 (SD 1.58), p = 0.18. The post-operative absolute surgical accuracy was a mean 12 (7.5) for Tomofix versus 4.1 (2.3) for OPTY-LINE, p = 0.052. At baseline, however, Tomofix patients had more knee symptoms, as determined by KOOS symptom sub-score, when compared to the OPTY-LINE cohort ( p = 0.009).

Conclusion: This initial, non-randomized, comparative evaluation of the OPTY-LINE device for HTO has produced similar outcomes to patients treated with the established Tomofix device. In particular, the rate of post-surgical bone regeneration and surgical accuracy achieved with the OPTY-LINE device are encouraging. Large-scale randomized controlled studies with longer follow-up are indicated to further evaluate the clinical and patient-related outcome performance for OPTY-LINE.

Item Type: Article
Journal / Publication Title: Journal of Orthopaedic Surgery
Publisher: SAGE Publications / Hong Kong University Press
ISSN: 2309-4990
Departments: Research Office & Graduate School (ROGS)
Additional Information: Leon Jonker, R&D Manager North Cumbria University Hospitals NHS Trust and Honorary Research Fellow at University of Cumbria, UK. This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed.
Depositing User: Insight Administrator
SWORD Depositor: Insight Administrator
Date Deposited: 12 Sep 2019 10:31
Last Modified: 12 Sep 2019 13:17
URI: http://insight.cumbria.ac.uk/id/eprint/5039

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