Lithium for Fracture Treatment: a Double Blind Randomized Controlled Trial (LiFT)

Launched by SUNNYBROOK HEALTH SCIENCES CENTRE · Dec 16, 2016

Keywords

ClinConnect Summary

The Lithium for Fracture Treatment (LiFT) trial is a research study looking at whether a low dose of lithium, taken for two weeks, can help heal fractures better and improve how well patients can function in their daily lives. Researchers are particularly interested in patients aged 18 to 55 who have specific types of fractures, such as those in the arm, leg, or collarbone, and who are generally healthy. If you or someone you know has recently suffered one of these fractures and meets the eligibility criteria, you might be able to participate in the study.

Participants in this trial will receive either lithium or a placebo (a pill that looks like the treatment but has no active ingredients) for two weeks. Throughout the study, researchers will monitor how well the fractures heal and whether patients experience any changes in their ability to perform everyday activities. It’s important to know that some individuals, like those who are pregnant, have certain health conditions, or are currently taking specific medications, may not be eligible to join the study. If you’re interested, the trial is currently recruiting participants, and you’ll receive more information about what to expect if you choose to take part.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age 18-55 years.
• • 2. ASA (American Society of Anesthesiologists) ≤ 2 class (healthy) prior to injury.
• • 3. Diaphyseal fracture of the humerus, femur or combined tibia/fibula (OTA diaphyseal subclass 2A or B), and clavicle (OTA diaphyseal subclass B1 or B2), with or without nerve injury.
• • 4. Fracture that is primarily closed or open fracture that has complete wound coverage.
• • 5. Randomization ≤14 days from injury or surgery (for surgical patients).
• • 6. Fractures treated surgically or nonsurgically by endochondral/secondary bone healing.
• • 7. For surgical patients, surgery must be within 14 days of injury.
• Exclusion Criteria:
• • 1. Currently pregnant or breastfeeding.
• • 2. Any past or current malignancy that, in the opinion of an investigator, is not medically controlled.
• • 3. Metabolic bone disease based on clinical history that, in the opinion of an investigator, is not medically controlled.
• • 4. Autoimmune disease that, in the opinion of an investigator, is not medically controlled.
• • 5. Hypothyroidism based on clinical history that, in the opinion of an investigator, is not medically controlled.
• • 6. Renal impairment based on clinical history.
• • 7. Past allergy or adverse reaction to Lithium.
• • 8. Lactose intolerance.
• • 9. Fractures surgically treated with absolute stability/primary bone healing.
• • 10. Isolated tibia or isolated fibula fracture.
• • 11. Currently taking Lithium or anti-psychotic or anti-seizure medication for the treatment of these conditions or at the discretion of an investigator.
• • 12. Inability to comply with study protocol, in the opinion of the investigator(s).
• • 13. Participation in another interventional clinical trial, at the discretion of the principal investigator.
• • 14. Use of concomitant ultrasound or other bone stimulation device.