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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lithium carbonate | Experimental | Lithium carbonate 300mg capsule; once per day for 2 weeks. |
|
| Lactose placebo | Placebo Comparator | Lactose placebo capsule; once per day for 2 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lithium Carbonate | Drug | Intervention begins 14 days after injury for non-surgical participants and 2 weeks after surgery for participants who have surgical treatment of their fractures. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| visual analogue pain score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pujitha Rao | Contact | 416-480-5627 | lift@sunnybrook.ca | |
| Mariam Saleem | Contact | Mariam.saleem@sunnybrook.ca |
| Name | Affiliation | Role |
|---|---|---|
| Diane Nam, MSc,MD,FRCSC | Sunnybrook Health Sciences Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Victoria Regional Health Centre | Recruiting | Barrie | Ontario | L4M 6M2 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31915160 | Derived | Nam D, Balasuberamaniam P, Milner K, Kunz M, Vachhani K, Kiss A, Whyne C. Lithium for Fracture Treatment (LiFT): a double-blind randomised control trial protocol. BMJ Open. 2020 Jan 7;10(1):e031545. doi: 10.1136/bmjopen-2019-031545. |
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| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D002145 | Callosities |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D007642 | Keratosis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D016651 | Lithium Carbonate |
| D008094 | Lithium |
| ID | Term |
|---|---|
| D002254 | Carbonates |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D002255 | Carbonic Acid |
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| Lactose Placebo | Drug | Intervention begins 14 days after injury for non-surgical participants and 2 weeks after surgery for participants who have surgical treatment of their fractures. |
|
|
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) |
| 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) |
| 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) |
| 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) |
| 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) |
| Hamilton Health Sciences | Recruiting | Hamilton | Ontario | Canada |
|
| The Ottawa Hospital Civic Campus | Recruiting | Ottawa | Ontario | K1Y 4E9 | Canada |
|
| Sunnybrook Health Sciences Centre | Recruiting | Toronto | Ontario | M5R 3P6 | Canada |
|
| Unity Health St. Michael's Hospital | Recruiting | Toronto | Ontario | Canada |
|
| D017554 |
| Carbon Compounds, Inorganic |
| D018020 | Lithium Compounds |
| D008672 | Metals, Alkali |
| D004602 | Elements |
| D019565 | Metals, Light |
| D008670 | Metals |