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

Fractures Clinical Trial

— LiFT  

Official title:

Lithium for Fracture Treatment: a Double Blind Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02999022
• Other study ID #: LiFT001
• Status: Recruiting
• Phase: Phase 2
• Start date: July 21, 2017
• Est. completion date: June 2025

Study information

• Verified date: January 2024
• Source: Sunnybrook Health Sciences Centre
• Contact: Pujitha Rao
• Phone: 416-480-5627
• Email: lift[@]sunnybrook.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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 (clavicle, 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: June 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fractures
• Fractures, Bone

Intervention

Drug:
• Lithium Carbonate
Intervention begins 14 days after injury for non-surgical participants and 2 weeks after surgery for participants who have surgical treatment of their fractures.
• Lactose Placebo
Intervention begins 14 days after injury for non-surgical participants and 2 weeks after surgery for participants who have surgical treatment of their fractures.

Locations

Country	Name	City	State
Canada	Royal Victoria Regional Health Centre	Barrie	Ontario
Canada	Hamilton Health Sciences	Hamilton	Ontario
Canada	The Ottawa Hospital Civic Campus	Ottawa	Ontario
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
Canada	Unity Health St. Michael's Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	radiographic healing of fracture	radiographic healing using the RUST score at 8 weeks	8 weeks after injury (non-surgical participants) or 8 weeks after surgery (surgical participants)
Secondary	radiographic union of fracture	time to radiographic union using the RUST score	4, 6, 12, and 24 weeks after injury (non-surgical participants) or 4, 6, 12, and 24 weeks after surgery (surgical participants)
Secondary	visual analogue pain score	changes from baseline in participant-reported average pain in past week as measured on a visual analogue scale from 0-10 where 0 is no pain and 10 is extreme pain	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)
Secondary	physical function	changes in participant-reported function from baseline as measured on the RAND SF36 questionnaire	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)
Secondary	NSAID use	to track participant-reported use of non-steroidal anti-inflammatory medication and measure changes over the course of the study	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)
Secondary	re-operation (after initial fracture management)	surgery required after initial fracture management	4, 6, 8, 12, and 24 weeks after injury (non-surgical participants) or 4, 6, 8, 12, and 24 weeks after surgery (surgical participants)
Secondary	adverse events	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	2-6 weeks after injury (non-surgical participants) or 2-6 weeks after surgery (surgical participants)