Intramedullary nail fixation versus locking plate fixation for adults with a fracture of the distal tibia: the UK FixDT RCT

Matthew L Costa; Juul Achten; Susie Hennings; Nafisa Boota; James Griffin; Stavros Petrou; Mandy Maredza; Melina Dritsaki; Thomas Wood; James Masters; Ian Pallister; Sarah E Lamb; Nick R Parsons

doi:10.3310/hta22250

$Cover of Intramedullary nail fixation versus locking plate fixation for adults with a fracture of the distal tibia: the UK FixDT RCT$

Intramedullary nail fixation versus locking plate fixation for adults with a fracture of the distal tibia: the UK FixDT RCT

Health Technology Assessment, No. 22.25

Authors

Matthew L Costa,^1,2,3^,* Juul Achten,^1,3 Susie Hennings,¹ Nafisa Boota,¹ James Griffin,¹ Stavros Petrou,¹ Mandy Maredza,¹ Melina Dritsaki,³ Thomas Wood,² James Masters,^2,3 Ian Pallister,⁴ Sarah E Lamb,^1,3 and Nick R Parsons¹; on behalf of the UK FixDT trial investigators.

Affiliations

¹ Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK

² Department of Trauma and Orthopaedics, University Hospitals Coventry and Warwickshire NHS Trust, Coventry, UK

³ Oxford Trauma, Nuffield Department of Orthopaedics, Rheumatology & Musculoskeletal Sciences, University of Oxford, Oxford, UK

⁴ Medical School, Swansea University, Swansea, Wales

^* Corresponding author; Email: ku.ca.xo.smrodn@atsoc.wehttam

Southampton (UK): NIHR Journals Library; 2018 May.

Copyright © Queen’s Printer and Controller of HMSO 2018. This work was produced by Costa et al. under the terms of a commissioning contract issued by the Secretary of State for Health and Social Care. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK.

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Headline

Both nail fixation and locking plate fixation had similar disability ratings at 6 months, but nail fixation cost about £970 less in the first year after the fracture.

Abstract

Background:

The best treatment for fractures of the distal tibia remains controversial. Most of these fractures require surgical fixation, but the outcomes are unpredictable and complications are common.

Objectives:

To assess disability, quality of life, complications and resource use in patients treated with intramedullary (IM) nail fixation versus locking plate fixation in the 12 months following a fracture of the distal tibia.

Design:

This was a multicentre randomised trial.

Setting:

The trial was conducted in 28 UK acute trauma centres from April 2013 to final follow-up in February 2017.

Participants:

In total, 321 adult patients were recruited. Participants were excluded if they had open fractures, fractures involving the ankle joint, contraindication to nailing or inability to complete questionnaires.

Interventions:

IM nail fixation (n = 161), in which a metal rod is inserted into the hollow centre of the tibia, versus locking plate fixation (n = 160), in which a plate is attached to the surface of the tibia with fixed-angle screws.

Main outcome measures:

The primary outcome measure was the Disability Rating Index (DRI) score, which ranges from 0 points (no disability) to 100 points (complete disability), at 6 months with a minimum clinically important difference of 8 points. The DRI score was also collected at 3 and 12 months. The secondary outcomes were the Olerud–Molander Ankle Score (OMAS), quality of life as measured using EuroQol-5 Dimensions (EQ-5D), complications such as infection, and further surgery. Resource use was collected to inform the health economic evaluation.

Results:

Participants had a mean age of 45 years (standard deviation 16.2 years), were predominantly male (61%, 197/321) and had experienced traumatic injury after a fall (69%, 223/321). There was no statistically significant difference in DRI score at 6 months [IM nail fixation group, mean 29.8 points, 95% confidence interval (CI) 26.1 to 33.7 points; locking plate group, mean 33.8 points, 95% CI 29.7 to 37.9 points; adjusted difference, 4.0 points, 95% CI –1.0 to 9.0 points; p = 0.11]. There was a statistically significant difference in DRI score at 3 months in favour of IM nail fixation (IM nail fixation group, mean 44.2 points, 95% CI 40.8 to 47.6 points; locking plate group, mean 52.6 points, 95% CI 49.3 to 55.9 points; adjusted difference 8.8 points, 95% CI 4.3 to 13.2 points; p < 0.001), but not at 12 months (IM nail fixation group, mean 23.1 points, 95% CI 18.9 to 27.2 points; locking plate group, 24.0 points, 95% CI 19.7 to 28.3 points; adjusted difference 1.9 points, 95% CI –3.2 to 6.9 points; p = 0.47). Secondary outcomes showed the same pattern, including a statistically significant difference in mean OMAS and EQ-5D scores at 3 and 6 months in favour of IM nail fixation. There were no statistically significant differences in complications, including the number of postoperative infections (13% in the locking plate group and 9% in the IM nail fixation group). Further surgery was more common in the locking plate group (12% in locking plate group and 8% in IM nail fixation group at 12 months). The economic evaluation showed that IM nail fixation provided a slightly higher quality of life in the 12 months after injury and at lower cost and, therefore, it was cost-effective compared with locking plate fixation. The probability of cost-effectiveness for IM nail fixation exceeded 90%, regardless of the value of the cost-effectiveness threshold.

Limitations:

As wound dressings after surgery are clearly visible, it was not possible to blind the patients to their treatment allocation. This evidence does not apply to intra-articular (pilon) fractures of the distal tibia.

Conclusions:

Among adults with an acute fracture of the distal tibia who were randomised to IM nail fixation or locking plate fixation, there were similar disability ratings at 6 months. However, recovery across all outcomes was faster in the IM nail fixation group and costs were lower.

Future work:

The potential benefit of IM nail fixation in several other fractures requires investigation. Research is also required into the role of adjuvant treatment and different rehabilitation strategies to accelerate recovery following a fracture of the tibia and other long-bone fractures in the lower limb. The patients in this trial will remain in longer-term follow-up.

Trial registration:

Current Controlled Trials ISRCTN99771224 and UKCRN 13761.

Funding:

This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 22, No. 25. See the NIHR Journals Library website for further project information.

About the Series

Health Technology Assessment

ISSN (Print): 1366-5278

ISSN (Electronic): 2046-4924

Article history

The research reported in this issue of the journal was funded by the HTA programme as project number 11/136/04. The contractual start date was in March 2013. The draft report began editorial review in March 2017 and was accepted for publication in November 2017. The authors have been wholly responsible for all data collection, analysis and interpretation, and for writing up their work. The HTA editors and publisher have tried to ensure the accuracy of the authors’ report and would like to thank the reviewers for their constructive comments on the draft document. However, they do not accept liability for damages or losses arising from material published in this report.

Declared competing interests of authors

Matthew L Costa is a member of the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) General Board and reports grants from the trauma industry (Stryker Corporation, X-Bolt Orthopaedics, Onbone, Smith & Nephew plc, Heraeus Holding GmbH and DePuy Synthes Companies); grants from the AO Foundation; and grants from NIHR and the European Union outside the submitted work. Sarah E Lamb was a member of the NIHR HTA Additional Capacity Funding Board, NIHR HTA End of Life Care and Add-on Studies, NIHR HTA Prioritisation Group and NIHR HTA Trauma Board during this study.

Last reviewed: March 2017; Accepted: November 2017.

Copyright © Queen’s Printer and Controller of HMSO 2018. This work was produced by Costa et al. under the terms of a commissioning contract issued by the Secretary of State for Health and Social Care. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK.

Bookshelf ID: NBK500128DOI: 10.3310/hta22250