Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
100 participants
INTERVENTIONAL
2019-11-12
2025-05-30
Brief Summary
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Detailed Description
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Randomization will take place immediately following the identification of a potential participant. The control group will receive the standard of care for diaphyseal tibia fractures. The standard of care consists of intramedullary nailing and post-operative opioids for pain control. The interventional group will have the same surgical indication and intervention but will differ in the primary method of pain control. The study group will receive NSAIDs and a reduced dosage of opioids for pain control. Primary outcome measures will be time to union, non-union, and pain over the post-operative period measured by a VAS pain scale. Once the data collection of both groups is complete, the statistical analysis will begin to determine if there is a statistical difference between the control and study groups in the primary outcome measurements.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
Randomization will take place immediately following the identification of a potential participant. The control group will receive the standard of care for diaphyseal tibia fractures. The standard of care consists of intramedullary nailing and post-operative opioids for pain control. The interventional group will have the same surgical indication and intervention but will differ in the primary method of pain control. The study group will receive NSAIDs and a reduced dosage of opioids for pain control. Primary outcome measures will be time to union, non-union, and pain over the post-operative period measured by a VAS pain scale. Once the data collection of both groups is complete, the statistical analysis will begin to determine if there is a statistical difference between the control and study groups in the primary outcome measurements
TREATMENT
NONE
Study Groups
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NSAIDs
This arm is given NSAIDs perioperatively and after discharge
NSAIDs
The patients will be given NSAIDs with a reduced dose of the standard opioids treatment.
Opioids
This arm will be given the standard opioids treatment to control pain perioperatively and at discharge.
No interventions assigned to this group
Interventions
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NSAIDs
The patients will be given NSAIDs with a reduced dose of the standard opioids treatment.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diaphyseal tibia fracture (OTA/AO 42 A, B)
Exclusion Criteria
18 Years
105 Years
ALL
No
Sponsors
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University of Louisville
OTHER
Responsible Party
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Rodolfo Zamora, MD
Associate Professor
Principal Investigators
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Rodolfo Zamora, MD
Role: PRINCIPAL_INVESTIGATOR
University of Louisville
Locations
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University of Louisville Hospital
Louisville, Kentucky, United States
University of Louisville
Louisville, Kentucky, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Giannoudis PV, Hak D, Sanders D, Donohoe E, Tosounidis T, Bahney C. Inflammation, Bone Healing, and Anti-Inflammatory Drugs: An Update. J Orthop Trauma. 2015 Dec;29 Suppl 12:S6-9. doi: 10.1097/BOT.0000000000000465.
Lu C, Xing Z, Wang X, Mao J, Marcucio RS, Miclau T. Anti-inflammatory treatment increases angiogenesis during early fracture healing. Arch Orthop Trauma Surg. 2012 Aug;132(8):1205-13. doi: 10.1007/s00402-012-1525-4. Epub 2012 May 24.
Sathyendra V, Darowish M. Basic science of bone healing. Hand Clin. 2013 Nov;29(4):473-81. doi: 10.1016/j.hcl.2013.08.002. Epub 2013 Oct 15.
Schindeler A, McDonald MM, Bokko P, Little DG. Bone remodeling during fracture repair: The cellular picture. Semin Cell Dev Biol. 2008 Oct;19(5):459-66. doi: 10.1016/j.semcdb.2008.07.004. Epub 2008 Jul 25.
Geusens P, Emans PJ, de Jong JJ, van den Bergh J. NSAIDs and fracture healing. Curr Opin Rheumatol. 2013 Jul;25(4):524-31. doi: 10.1097/BOR.0b013e32836200b8.
Marquez-Lara A, Hutchinson ID, Nunez F Jr, Smith TL, Miller AN. Nonsteroidal Anti-Inflammatory Drugs and Bone-Healing: A Systematic Review of Research Quality. JBJS Rev. 2016 Mar 15;4(3):e4. doi: 10.2106/JBJS.RVW.O.00055.
Other Identifiers
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19.0676
Identifier Type: -
Identifier Source: org_study_id
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