Clinical Trial: Lithium for Fracture Treatment

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Lithium for Fracture Treatment: a Double Blind Randomized Control Trial

Brief Summary: This is a study designed to see if a low dose of Lithium treatment, taken for 2 weeks, can improve fracture healing and improve patients' function and productivity.

Detailed Summary:

Despite the success of traditional treatments for broken bones (surgery, immobilization, or both) 10% of fractures do not heal or take longer than normal to heal. This can have a significant effect on a patient's function and productivity, as well as on healthcare expenditures. Very few advances in fracture healing have been made, despite the need for new approaches to fracture treatment. This study proposes a simple, economical, and non-invasive approach to complement traditional fracture treatment that could decrease healing time and reduce the incidence of delayed healing. The investigators think that this can improve health outcomes for patients and reduce health care costs for the healthcare system in general. The goal is to see if a low-dose of Lithium treatment can have a positive effect on fracture healing and can reduce pain and improve function in patients who have broken a bone.

The LiFT study is a participant, surgeon and observer blinded single-centre randomized (1:1), controlled, superiority trial with 2 parallel groups. A minimization procedure will stratify participants based on the fractured long bone (humerus, femur or tibia/fibula) and smoking.

Participants will be randomized to 1 of 2 groups: lithium capsules or placebo. The Lithium/placebo will be taken daily for 2 weeks, starting 2 weeks after the fracture occurs (or 2 weeks after surgery if the participant is treated with surgery).


Sponsor: Sunnybrook Health Sciences Centre

Current Primary Outcome: radiographic healing of fracture [ Time Frame: 8 weeks after injury (non-surgical participants) or 8 weeks after surgery (surgical participants) ]

to determine if the study protocol for lithium treatment after fracture can accelerate radiographic healing when compared to placebo


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • radiographic union of fracture [ Time Frame: 4, 6, 12, and 24 weeks after injury (non-surgical participants) or 4, 6, 12, and 24 weeks after surgery (surgical participants) ]
  • pain [ Time Frame: baseline then 4, 6, 8, 12, and 24 weeks after injury (non-surgical participants) or baseline then 4, 6, 8, 12, and 24 weeks after surgery (surgical participants) ]
    to measure changes in participant-reported pain as measured on a visual analogue scale (VAS)
  • physical function [ Time Frame: baseline then 4, 6, 8, 12, and 24 weeks after injury (non-surgical participants) or baseline then 4, 6, 8, 12, and 24 weeks after surgery (surgical participants) ]
    to measure changes in participant-reported function as measured on the RAND SF36 questionnaire
  • NSAID use [ Time Frame: baseline then 3, 4, 6, 8, 12, and 24 weeks after injury (non-surgical participants) or baseline then 3, 4, 6, 8, 12, and 24 weeks after surgery (surgical participants) ]
    to track participant-reported use of non-steroidal anti-inflammatory medication and measure changes over the course of the study
  • re-operation (after initial fracture management) [ Time Frame: 4, 6, 8, 12, and 24 weeks after injury (non-surgical participants) or 4, 6, 8, 12, and 24 weeks after surgery (surgical participants) ]
    surgery required after initial fracture management
  • adverse events [ Time Frame: 2-6 weeks after injury (non-surgical participants) or 2-6 weeks after surgery (surgical participants) ]
    the number and type of adverse events occuring after the first dose of lithium/placebo and until the 6-week visit will be collected and reported according to local and national rules and regulations


Original Secondary Outcome: Same as current

Information By: Sunnybrook Health Sciences Centre

Dates:
Date Received: September 9, 2016
Date Started: April 17, 2017
Date Completion: August 2019
Last Updated: April 17, 2017
Last Verified: April 2017