Lithium for Fracture Treatment (LiFT): a double-blind randomised control trial protocol

Diane Nam, Phumeena Balasuberamaniam, Katrine Milner, Monica Kunz, Kathak Vachhani, Alex Kiss, Cari Whyne, Diane Nam, Phumeena Balasuberamaniam, Katrine Milner, Monica Kunz, Kathak Vachhani, Alex Kiss, Cari Whyne

Abstract

Introduction: Fracture healing can fail in up to 10% of cases despite appropriate treatment. While lithium has been the standard treatment for bipolar disorder, it may also have a significant impact to increase bone healing in patients with long bone fractures. To translate this knowledge into clinical practice, a randomised clinical trial (RCT) is proposed.

Methods and analysis: A multicentre double blind, placebo-controlled RCT is proposed to evaluate the efficacy of lithium to increase the rate and predictability of long bone fracture healing in healthy adults compared to lactose placebo treatment. 160 healthy individuals from 18 to 55 years of age presenting with shaft fractures of the femur, tibia/fibula, humerus or clavicle will be eligible. Fractures will be randomised to placebo (lactose) or treatment (300 mg lithium carbonate) group within 2 weeks of the injury. The primary outcome measure will be radiographic union defined as visible callus bridging on three of the four cortices at the fracture site using a validated radiographic union score. Secondary outcome measures will include functional assessment and pain scoring.

Ethics and dissemination: Participant confidentiality will be maintained with publication of results. Research Ethics Board Approval: Sunnybrook Research Institute (REB # 356-2016). Health Canada Approval (HC6-24-C201560). Results of the main trial and secondary endpoints will be submitted for publication in a peer-reviewed journal and presented at conferences.

Trial registration number: NCT02999022.

Keywords: adult orthopaedics; clinical trials; orthopaedic & trauma surgery; trauma management.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Overview of trial procedure. Clinic visit dates are relative to date of injury (for non-operative patients) or surgery (for operative patients). KT Survey = knowledge translation survey; ER = emergency department.

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