Intramedullary Calcium Sulfate Antibiotic Depot

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial Description

This research is a randomized clinical trial aimed to reduce the frequency of fracture related infections following open tibia fracture. The proposed test methods for infection reduction is use of an antibiotic depot placed inside the bone at the time of final fracture treatment. This is in addition to standard of care wound care, fracture fixation with intramedullary nailing, and peri-operative systemic antibiotics. This prospective randomized clinical trial will compare outcomes between patients treated with an antibiotic depot placed inside the bone at the time of final fracture fixation and those treated with traditional standard of care intramedullary nailing. The target population for the proposed study is patients with severe open tibia fractures (Type II or III) who require definitive fixation with intramedullary nail recruited form one of the participating sites during the index hospitalization. One group will be treated prophylactically suing a calcium sulfate antibiotic depot at the time of definitive fixation, while the second group will be treated with a standard of care intramedullary nail without the antibiotic depot. Participants will be followed for 12 months (data capture includes patient interviews and clinical data capture from the treatment team and medical record at baseline, 6 weeks, 3 months, 6 months, and 12 months). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05766670
Study type	Interventional
Source	Wake Forest University Health Sciences
Contact	Christine Churchill, MA
Phone	7043552000
Email	christine.churchill@atriumhealth.org
Status	Not yet recruiting
Phase	Phase 3
Start date	June 2024
Completion date	January 2028

View Details

See also
Status	Clinical Trial	Phase
Not yet recruiting	`NCT05459038` - Clinical Validation of the C-Arm Rotational View (CARV) to Avoid Rotational Malalignment After Intramedullary Nailing of Tibial Shaft Fractures.	N/A
Terminated	`NCT02845245` - Comminuted Intra-Articular Distal Tibia Fracture Fixation Using Computer Techniques	N/A
Completed	`NCT02456194` - Management of Traumatic Bone Defects in Tibial Plateau Fractures With Antibiotic-Impregnated Biodegradable Calcium Sulfate Beads: A Prospective Clinical Trial	N/A
Completed	`NCT01132508` - Use of a Reinforced Injectable Calcium Phosphate Bone Cement in the Treatment of Tibial Plateau Fractures	N/A
Terminated	`NCT00667849` - Trial to Evaluate UltraSound in the Treatment of Tibial Fractures	N/A
Completed	`NCT00512434` - Percutaneous Autologous Bone-marrow Grafting for Open Tibial Shaft Fracture	N/A
Completed	`NCT00161616` - Study Evaluating InductOs in Diaphyseal Tibia Fractures	Phase 4
Terminated	`NCT03881241` - Safety Study of Treatment of Leg Fractures
Completed	`NCT02750072` - INfrapatellar Versus SUprapatellar Reamed Intramedullary Nailing for Fractures of the Tibia	N/A
Completed	`NCT04015167` - A Post-Market Clinical Evaluation of the Treatment of Tibia Fractures With the T2 Alpha Tibia Nailing System
Recruiting	`NCT06451510` - Knee Osteoarthritis in the Region of Norrbotten
Completed	`NCT05613257` - Distal Targeter vs Free-hand	N/A
Completed	`NCT03388879` - Reamed Nailing Versus Taylor Spatial Frame in Tibia Shaft Fractures	N/A
Completed	`NCT02491047` - Safety and Performance of BonyPid-1000™ in the Treatment of Gustilo I, II, IIIA and IIIB Tibial Open Fractures	N/A
Completed	`NCT01797640` - Intramedullary Nailing of Tibia Fractures	N/A
Recruiting	`NCT03232216` - Vitamin D Supplementation and Tibia Fracture. Does it Improve Healing Rate?	N/A
Withdrawn	`NCT03826784` - Bone Healing Accelerant Versus Standard of Care for Open Tibia Fractures	Phase 3
Terminated	`NCT00253981` - Light Therapy in the Treatment of Leg Pain	N/A
Completed	`NCT05303389` - Posterior Plating Versus Anterior to Posterior Screws in Fixation of Posterior Column in Pilon Fractures	N/A
Recruiting	`NCT05272631` - Depuy Synthes Lower Extremity Shaft Nail Registry