Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05766670 · ClinicalTrials.gov registry record · Phase 3
Intramedullary Calcium Sulfate Antibiotic Depot
A Phase 3 study of Tibial Fractures and Osteomyelitis Tibia, sponsored by Wake Forest University Health Sciences.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 497
- Enrollment target
- 10
- Study locations
NCT05766670: Recruiting Phase 3 study of Tibial Fractures and Osteomyelitis Tibia, sponsored by Wake Forest University Health Sciences.
NCT05766670 is a Phase 3 study of Tibial Fractures and Osteomyelitis Tibia that is actively recruiting participants, run by Wake Forest University Health Sciences. The registered enrollment target is 497 participants, above the 299-participant average among 12 other Tibial Fractures trials with a reported enrollment target (66% higher). The trial reports 10 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05766670, a Phase 3 study of Tibial Fractures and Osteomyelitis Tibia, is actively recruiting participants, sponsored by Wake Forest University Health Sciences.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 497 participants
- Enrollment target
- 10
- Study locations
Study Summary
The goal of this randomized clinical trial is to study the best treatment for open lower leg fractures to prevent infection. The main questions it aims to answer is if treating tibia fracture patients with a calcium sulfate antibiotic depot is better at preventing infection that the standard of care.
Primary Outcome
Number of participants in each group who develop surgical site infection (SSI) as defined by the criteria establish by the Centers for Disease Control and Prevention (CDC). The CDC criteria define deep as occurring within 30 or 90 days after the procedure. However, we will continue to follow patients for 12 months and document any infections and other complications during this period.
Conditions Studied
Interventions
- OTHER Standard Intramedullary Nail
- DRUG Vancomycin Hydrochloride
- DRUG Gentamicin
Study Locations (10)
North Carolina
- Atrium Health Carolinas Medical Center - Charlotte
- Atrium Health Cabarrus - Concord
- Atrium Health Wake Forest Baptist Medical Center - Winston-Salem
California
- Cedars-Sinai - Los Angeles
Georgia
- Atrium Health Navicent The Medical Center - Macon
Kentucky
- University of Kentucky - Lexington
Louisiana
- Louisiana State University Health Sciences Center - New Orleans
Pennsylvania
- Pennsylvania State University - Hershey
Tennessee
- Vanderbilt University Medical Center - Nashville
Virginia
- Valley Health - Winchester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 497 participants |
| Start Date | 2024-04-08 |
| Est. Completion | 2028-01 |
| Phase | Phase 3 |
What NCT05766670 shows while recruiting
NCT05766670 is an interventional study that assigns participants to a tested intervention. The registered 497 participants enrollment target is mid-sized for trials with a published cap, above the 299-participant average among 12 other Tibial Fractures trials with a reported enrollment target (66% higher).
The record links to 3 conditions, with Tibial Fractures appearing as the primary indexed condition, and to 3 interventions - of which Standard Intramedullary Nail is the first listed.
NCT05766670 lists 10 locations in 8 states (North Carolina, California, Georgia).
Frequently Asked Questions
What is clinical trial NCT05766670 about?
NCT05766670 is a clinical study titled "Intramedullary Calcium Sulfate Antibiotic Depot". The goal of this randomized clinical trial is to study the best treatment for open lower leg fractures to prevent infection. The main questions it aims to answer is if treating tibia fracture patients with a calcium sulfate antibiotic depot is better at preventing infection that the standard of care...
What is the current status of trial NCT05766670?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 497 participants. The study started on 2024-04-08. Estimated completion is 2028-01.
What conditions does trial NCT05766670 study?
This clinical trial studies the following conditions: Tibial Fractures, Osteomyelitis Tibia, Open tíbia Fracture.
What interventions are being tested in trial NCT05766670?
The interventions under investigation include: Standard Intramedullary Nail (OTHER), Vancomycin Hydrochloride (DRUG), Gentamicin (DRUG).
Who is sponsoring clinical trial NCT05766670?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05766670 being conducted?
This trial has 10 study locations across California, Georgia, Kentucky, Louisiana, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Tibial Fractures
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05766670's enrollment target sits among peer trials
497 3rd of 12 higher than 10 of 12 other Tibial Fractures trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Tibial Fractures trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Effect of NSAIDs on Union, Opioid Utilization and Pain Management for Tibia Fractures: A Pragmatic, Randomized Controlled Trial
RECRUITING · Phase 3
-
Comparison of Healing Measures Tibial Fractures Following Standard Intramedullary Nailing or Micromotion Tibial Intramedullary Nailing
RECRUITING · NA
-
Prophylactic Antibiotic Coated Nail to Prevent Infection: A Clinical Trial
RECRUITING · Phase 4
-
Does Joint Lavage Reduce Intraarticular Inflammation in High-energy Tibial Pilon Fractures?
RECRUITING · NA
-
Blood Flow Restriction Training in Patients With Lower Extremity Fractures
RECRUITING · NA
-
Intramedullary Bone Grafting for Open Tibial Shaft Fractures
RECRUITING · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03175224 · 497 participants · Phase 2
APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors
- NCT05301816 · 497 participants · NA
PDN Post Market, Multicenter, Prospective, Global Clinical Study
- NCT05283720 · 496 participants · Phase 2
A Study to Evaluate Adverse Events and Change in Disease Activity of Subcutaneous (SC) Epcoritamab in Combination With Oral and Intravenous Anti-Neoplastic Agents in Adult Participants With Non-Hodgkin Lymphoma
- NCT06417775 · 496 participants · Phase 3
Study of Oral Ubrogepant to Assess Adverse Events and Change in Disease Activity in Adult Participants With Menstrual Migraine
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI