Osteomyelitis TibiaPhase 4NCT05421741
Prophylactic Antibiotic Coated Nail to Prevent Infection: A Clinical Trial
A Phase 4 study testing Antibiotic coated intramedullary Nail and Standard Intramedullary Nail in people with Osteomyelitis Tibia and Tibial Fractures, run by Wake Forest University Health Sciences at 15 sites in United States.
Trial summary
This prospective randomized clinical trial will compare outcomes between patients treated primarily with a prophylactic antibiotic coated nail and those treated with traditional standard of care intramedullary (IM) nailing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteomyelitis Tibia, Tibial Fractures, Open Tibia Fracture
- What is being tested?
- Antibiotic coated intramedullary Nail and Standard Intramedullary Nail
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 242 participants
- Where
- 15 sitesUnited States
- Study dates
- 15 May 2023to Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 18 years or older
- Gustilo Type II or III open tibia fracture requiring definitive fixation with intramedullary nail
Who cannot join
- Less than 18 years of age
- Allergy to vancomycin or gentamicin
- Unable to speak English or Spanish
- Pregnant and lactating women
- Prisoner
- Unable to follow up for 12 months
Trial locations and contacts
15 sites in 1 country. Contact the study team or a site near you to ask about taking part.
15 sites in 1 country
United States15 sites, 15 recruiting
- Recruiting
University of North Carolina Chapel Hill
Chapel Hill, North Carolina, 27546
Andrew Chen, MD
Malvika Choudhari
- Recruiting
Atrium Health Carolinas Medical Center
Charlotte, North Carolina, 28203
Rachel B Seymour, PhD
Christine Churchill, MA
- Recruiting
The University of Chicago
Chicago, Illinois, 60637
Ashley Mayo, 773-906-4605, ashley.mayo@bsd.uchicago.edu
Brianna Fram, MD
- Recruiting
Atrium Health Cabarrus
Concord, North Carolina, 28025
Luke Harmer, MD
Erica Grochowski, MPH
- Recruiting
University of Florida Gainesville
Gainesville, Florida, 32607
Michael Talerico, MD
Marissa Pazik
- Recruiting
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
Jana Davis, MD, jdavis25@pennstatehealth.psu.edu
Uzma Muzammil, umuzammil@pennstatehealth.psu.edu
- Recruiting
University of Texas Houston
Houston, Texas, 77030
Stephen Warner, MD
Natasha Howard
- Recruiting
University of Kentucky
Lexington, Kentucky, 40536
Paul Matuszewski, MD
Paul Matuszewski, MD
- Recruiting
Atrium Health Navicent
Macon, Georgia, 31201
Jarrod Dumpe, MD
Jarrod Dumpe, MD
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Karen Trochez
Daniel Stinner, MD
- Not yet recruiting
Carilion Clinic
Roanoke, Virginia, 24016
Cody Evans, MD, 540-510-6200, clevans@carilionclinic.org
Cody Evans, MD
- Recruiting
San Antonio Military Medical Center
San Antonio, Texas, 78234
Raymond Kessler, MD
Raymond Kessler, MD
- Recruiting
Florida Orthopaedic Institute
Temple Terrace, Florida, 33637
Lisa Stang
Hassan Mir, MD
- Recruiting
Valley Health System
Winchester, Virginia, 22601
Kenneth Nelson, MD, skiarmy@yahoo.com
Ashley Zelaski, azelaski2@valleyhealthlink.com
- Recruiting
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27157
Martha Holden
Eben Carroll, MD
About this study
This prospective randomized clinical trial will compare outcomes between patients treated primarily with a prophylactic antibiotic coated nail and those treated with traditional standard of care intramedullary (IM) nailing.
Read the detailed description
Despite significant treatment advances and protocols to prevent infection, severe open fractures of the lower extremity still have very high rates of deep infection. Infection in an active duty military population increases disability and decreases the likelihood of returning to duty. In addition, infection is one of the main factors associated with rehospitalization. Further, deep infections have not only resulted in increased disability after injury, infection is implicated as one of the main factors in late amputation. Among service members, only 20-25% with a severe open tibia fracture are able to return to active duty. Novel techniques for reducing infection are needed. The proposed study addresses the focus area of fracture-related infections, specifically the prevention of infection.
This prospective randomized clinical trial will compare outcomes between patients treated primarily with a prophylactic antibiotic coated nail and those treated with traditional standard of care intramedullary (IM) nailing.
This prospective randomized clinical trial will compare outcomes between patients treated primarily with a prophylactic antibiotic coated nail and those treated with traditional standard of care intramedullary (IM) nailing.
The target population for the proposed study is patients with severe open tibia fractures (Type II or Type III) who require definitive fixation with intramedullary nail recruited from one of the participating sites during the index hospitalization.
One group will be treated prophylactically using an antibiotic coated intramedullary nail at time of definitive fixation (1CN), while the second group will be treated with traditional standard of care intramedullary nail without antibiotic-coating (SN).
Participant will be followed for 12 months (data capture including patient interviews and clinical data capture from the treatment team and medical record at baseline, 6 weeks, 3 months, 6 months, and 12 months).
- Conditions
- Osteomyelitis Tibia, Tibial Fractures, Open Tibia Fracture
- Being tested
- Antibiotic coated intramedullary Nail, Standard Intramedullary Nail
- Keywords
- Antibiotic-coated nail
- Medical subject headings
- Tibial Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antibiotic coated intramedullary NailDrug
Also called Local Gentamicin 560 Powder, Vancomycin 2gm Liquid
Antibiotic coated intramedullary nail:
A mixture of 40gm bag of acrylic cement, antibiotic powder (Vancomycin 2gm) and 560mg gentamicin liquid. The intramedullary is coated with the mixture using a cement gun tube.
Standard Intramedullary NailOther
Standard Intramedullary Nail
| Study group | Role | What they receive |
|---|---|---|
| Intramedullary Nail | Active comparator | Traditional standard of care intramedullary (IM) nail Receives: Other: Standard Intramedullary Nail |
| Antibiotic Coated Intramedullary Nail | Active comparator | Intramedullary Nail coated with 2 grams of vancomycin and 560 mg gentamicin liquid. Receives: Drug: Antibiotic coated intramedullary Nail |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants who develop deep surgical site infection (SSI)
Number of participants in each group who develop 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.
Measured: Day 30 through month 12
Secondary outcomes (14)
Radiographic Union Scale in Tibial fractures (RUST) score
The RUST score ranges from a minimum score of 4 (definitely not healed) to a maximum score of 12 (completely healed). The final x-ray obtained within a 12-month period following injury will be uploaded to REDCap for review by a blinded panel of investigators from participating sites.
Measured: week 6, month 3, month 6, and month 12
Percentage of Union
Union is the gradual process of bone regeneration after a fracture. Percentage of Union, as determined by the treating surgeon, will be assessed via radiographs. Recorded by surgeon as yes/no answers.
Measured: week 6, month 3, month 6 and month12
Time to Union
Captured in days
Measured: week 6, month 3, month 6 and month12
Average Time to Return to Work/Duty
number of days
Measured: week 6, month 3, month 6 and month12
International Physical Activity Questionnaire (IPAQ)
IPAQ measures the total amount of physical activity completed in a 7 day period by calculating the minutes per week in in each physical activity level domain (walking, moderate and vigorous) by a metabolic equivalent energy (MET) expenditure estimate.
Walking = 3.3 x number of walking minutes x number of walking days Moderate activity= 4.0 x number activity minutes x number of days Vigorous activity = 8 x number of activity minutes x number of days Total = Walking MET-min/wk+moderate MET-min/wk+vigorous MET-min/wk
Measured: week 6, month 3, month 6 and month12
Number of Subjects Who Have Returned to Work
Determined by asking whether subjects have returned to work
Measured: week 6, month 3, month 6 and month12
Number of Participants who Return to Operating Room (OR)
Measured: Month 12
PROMIS-29 Subscale--Physical Function
The PROMIS-29 scales will be scored using a T-score metric method. A score of 50 points represents the population average for each scale, and 10 points represent one standard deviation. Higher scores means higher physical function.
Measured: week 6, month 3, month 6 and month12
PROMIS-29 Subscale--Physical Function: Anxiety
The PROMIS-29 scales will be scored using a T-score metric method. A score of 50 points represents the population average for each scale, and 10 points represent one standard deviation. Higher scores means a higher level of anxiety.
Measured: week 6, month 3, month 6 and month12
PROMIS-29 Subscale--Depression
The PROMIS-29 scales will be scored using a T-score metric method. A score of 50 points represents the population average for each scale, and 10 points represent one standard deviation. Higher scores means a higher level of depression.
Measured: week 6, month 3, month 6 and month12
PROMIS-29 Subscale--Fatigue
The PROMIS-29 scales will be scored using a T-score metric method. A score of 50 points represents the population average for each scale, and 10 points represent one standard deviation. Higher scores means a higher level of fatigue.
Measured: week 6, month 3, month 6 and month12
PROMIS-29 Subscale--Sleep Disturbance
The PROMIS-29 scales will be scored using a T-score metric method. A score of 50 points represents the population average for each scale, and 10 points represent one standard deviation. Higher scores means a higher level of sleep disturbance.
Measured: week 6, month 3, month 6 and month12
PROMIS-29 Subscale--Pain Interference
The PROMIS-29 scales will be scored using a T-score metric method. A score of 50 points represents the population average for each scale, and 10 points represent one standard deviation. Higher scores means a higher level of pain interference.
Measured: week 6, month 3, month 6 and month12
PROMIS-29 Subscale--Ability to Participate in Social Roles and Activities
The PROMIS-29 scales will be scored using a T-score metric method. A score of 50 points represents the population average for each scale, and 10 points represent one standard deviation. Higher scores means a higher ability to participate in social roles and activities.
Measured: week 6, month 3, month 6 and month12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2022
- Study start15 May 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (38)Papers the sponsor has linked to this study.
- Other trials for Osteomyelitis TibiaStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 242 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joseph Hsu, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05421741
- Sponsor's protocol ID
- IRB00086285
- Other IDs
- 01012022, 40010222
- Status last verified
- May 2026
- First submitted
- 13 Jun 2022
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Owens BD, Kragh JF Jr, Macaitis J, Svoboda SJ, Wenke JC. Characterization of extremity wounds in Operation Iraqi Freedom and Operation Enduring Freedom. J Orthop Trauma. 2007 Apr;21(4):254-7. doi: 10.1097/BOT.0b013e31802f78fb.
PubMed 17414553Burns TC, Stinner DJ, Mack AW, Potter BK, Beer R, Eckel TT, Possley DR, Beltran MJ, Hayda RA, Andersen RC, Keeling JJ, Frisch HM, Murray CK, Wenke JC, Ficke JR, Hsu JR; Skeletal Trauma Research Consortium. Microbiology and injury characteristics in severe open tibia fractures from combat. J Trauma Acute Care Surg. 2012 Apr;72(4):1062-7. doi: 10.1097/TA.0b013e318241f534.
PubMed 22491628Bosse MJ, MacKenzie EJ, Kellam JF, Burgess AR, Webb LX, Swiontkowski MF, Sanders RW, Jones AL, McAndrew MP, Patterson BM, McCarthy ML, Travison TG, Castillo RC. An analysis of outcomes of reconstruction or amputation after leg-threatening injuries. N Engl J Med. 2002 Dec 12;347(24):1924-31. doi: 10.1056/NEJMoa012604.
PubMed 12477942Napierala MA, Rivera JC, Burns TC, Murray CK, Wenke JC, Hsu JR; Skeletal Trauma Research Education Consortium (STReC). Infection reduces return-to-duty rates for soldiers with Type III open tibia fractures. J Trauma Acute Care Surg. 2014 Sep;77(3 Suppl 2):S194-7. doi: 10.1097/TA.0000000000000364.
PubMed 25159355Johnson EN, Burns TC, Hayda RA, Hospenthal DR, Murray CK. Infectious complications of open type III tibial fractures among combat casualties. Clin Infect Dis. 2007 Aug 15;45(4):409-15. doi: 10.1086/520029. Epub 2007 Jul 5.
PubMed 17638186Ficke JR, Pollak AN. Extremity War Injuries: Development of Clinical Treatment Principles. J Am Acad Orthop Surg. 2007 Oct;15(10):590-5. doi: 10.5435/00124635-200710000-00003.
PubMed 17916782Section 1: Preventing and Managing Infection and Other Complications After Orthopaedic Trauma. J Orthop Trauma. 2017 Apr;31 Suppl 1:S2. doi: 10.1097/BOT.0000000000000798. No abstract available.
PubMed 28323794Masini BD, Owens BD, Hsu JR, Wenke JC. Rehospitalization after combat injury. J Trauma. 2011 Jul;71(1 Suppl):S98-102. doi: 10.1097/TA.0b013e3182218fbc.
PubMed 21795886Huh J, Stinner DJ, Burns TC, Hsu JR; Late Amputation Study Team. Infectious complications and soft tissue injury contribute to late amputation after severe lower extremity trauma. J Trauma. 2011 Jul;71(1 Suppl):S47-51. doi: 10.1097/TA.0b013e318221181d.
PubMed 21795878Cross JD, Stinner DJ, Burns TC, Wenke JC, Hsu JR; Skeletal Trauma Research Consortium (STReC). Return to duty after type III open tibia fracture. J Orthop Trauma. 2012 Jan;26(1):43-7. doi: 10.1097/BOT.0b013e31821c0ec1.
PubMed 21885998Bratzler DW, Houck PM; Surgical Infection Prevention Guidelines Writers Workgroup; American Academy of Orthopaedic Surgeons; American Association of Critical Care Nurses; American Association of Nurse Anesthetists; American College of Surgeons; American College of Osteopathic Surgeons; American Geriatrics Society; American Society of Anesthesiologists; American Society of Colon and Rectal Surgeons; American Society of Health-System Pharmacists; American Society of PeriAnesthesia Nurses; Ascension Health; Association of periOperative Registered Nurses; Association for Professionals in Infection Control and Epidemiology; Infectious Diseases Society of America; Medical Letter; Premier; Society for Healthcare Epidemiology of America; Society of Thoracic Surgeons; Surgical Infection Society. Antimicrobial prophylaxis for surgery: an advisory statement from the National Surgical Infection Prevention Project. Clin Infect Dis. 2004 Jun 15;38(12):1706-15. doi: 10.1086/421095. Epub 2004 May 26.
PubMed 15227616Pinto D, Manjunatha K, Savur AD, Ahmed NR, Mallya S, Ramya V. Comparative study of the efficacy of gentamicin-coated intramedullary interlocking nail versus regular intramedullary interlocking nail in Gustilo type I and II open tibia fractures. Chin J Traumatol. 2019 Oct;22(5):270-273. doi: 10.1016/j.cjtee.2019.03.006. Epub 2019 Jun 21.
PubMed 31443939Schmidmaier G, Kerstan M, Schwabe P, Sudkamp N, Raschke M. Clinical experiences in the use of a gentamicin-coated titanium nail in tibia fractures. Injury. 2017 Oct;48(10):2235-2241. doi: 10.1016/j.injury.2017.07.008. Epub 2017 Jul 10.
PubMed 28734495Jorge-Mora A, Amhaz-Escanlar S, Fernandez-Pose S, Garcia-Iglesias A, Mandia-Mancebo F, Franco-Trepat E, Guillan-Fresco M, Pino-Minguez J. Commercially available antibiotic-laden PMMA-covered locking nails for the treatment of fracture-related infections - A retrospective case analysis of 10 cases. J Bone Jt Infect. 2019 Jul 5;4(4):155-162. doi: 10.7150/jbji.34072. eCollection 2019.
PubMed 31555500Shiels SM, Mangum LH, Wenke JC. Revisiting the "race for the surface" in a pre-clinical model of implant infection. Eur Cell Mater. 2020 Jan 29;39:77-95. doi: 10.22203/eCM.v039a05.
PubMed 31995226
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Antibiotic Coated Nail to Prevent Infection: A Clinical Trial
- ClinicalTrials.gov ID
- NCT05421741
- Acronym / sponsor ID
- IRB00086285
- Conditions
- Osteomyelitis Tibia, Tibial Fractures, Open Tibia Fracture
- Keywords
- Antibiotic-coated nail
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 242 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 15 May 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 16 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective randomized clinical trial will compare outcomes between patients treated primarily with a prophylactic antibiotic coated nail and those treated with traditional standard of care intramedullary (IM) nailing.
Detailed description
Despite significant treatment advances and protocols to prevent infection, severe open fractures of the lower extremity still have very high rates of deep infection. Infection in an active duty military population increases disability and decreases the likelihood of returning to duty. In addition, infection is one of the main factors associated with rehospitalization. Further, deep infections have not only resulted in increased disability after injury, infection is implicated as one of the main factors in late amputation. Among service members, only 20-25% with a severe open tibia fracture are able to return to active duty. Novel techniques for reducing infection are needed. The proposed study addresses the focus area of fracture-related infections, specifically the prevention of infection.
This prospective randomized clinical trial will compare outcomes between patients treated primarily with a prophylactic antibiotic coated nail and those treated with traditional standard of care intramedullary (IM) nailing.
This prospective randomized clinical trial will compare outcomes between patients treated primarily with a prophylactic antibiotic coated nail and those treated with traditional standard of care intramedullary (IM) nailing.
The target population for the proposed study is patients with severe open tibia fractures (Type II or Type III) who require definitive fixation with intramedullary nail recruited from one of the participating sites during the index hospitalization.
One group will be treated prophylactically using an antibiotic coated intramedullary nail at time of definitive fixation (1CN), while the second group will be treated with traditional standard of care intramedullary nail without antibiotic-coating (SN).
Participant will be followed for 12 months (data capture including 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intramedullary Nail | Active comparator | Other: Standard Intramedullary NailTraditional standard of care intramedullary (IM) nail |
| Antibiotic Coated Intramedullary Nail | Active comparator | Drug: Antibiotic coated intramedullary NailIntramedullary Nail coated with 2 grams of vancomycin and 560 mg gentamicin liquid. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients 18 years or older
- Gustilo Type II or III open tibia fracture requiring definitive fixation with intramedullary nail
Key exclusion criteria (6 listed)
- Less than 18 years of age
- Allergy to vancomycin or gentamicin
- Unable to speak English or Spanish
- Pregnant and lactating women
- Prisoner
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antibiotic coated intramedullary NailAlso: Local Gentamicin 560 Powder, Vancomycin 2gm LiquidAntibiotic coated intramedullary nail: A mixture of 40gm bag of acrylic cement, antibiotic powder (Vancomycin 2gm) and 560mg gentamicin liquid. The intramedullary is coated with the mixture using a cement gun tube. | Drug | Antibiotic Coated Intramedullary Nail |
| Standard Intramedullary NailStandard Intramedullary Nail | Other | Intramedullary Nail |
Primary outcome
Number of Participants who develop deep surgical site infection (SSI)
Time frame: Day 30 through month 12
Number of participants in each group who develop 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.
14 secondary outcomes
Radiographic Union Scale in Tibial fractures (RUST) score
Time frame: week 6, month 3, month 6, and month 12
Percentage of Union
Time frame: week 6, month 3, month 6 and month12
Time to Union
Time frame: week 6, month 3, month 6 and month12
Average Time to Return to Work/Duty
Time frame: week 6, month 3, month 6 and month12
International Physical Activity Questionnaire (IPAQ)
Time frame: week 6, month 3, month 6 and month12
Number of Subjects Who Have Returned to Work
Time frame: week 6, month 3, month 6 and month12
Number of Participants who Return to Operating Room (OR)
Time frame: Month 12
PROMIS-29 Subscale--Physical Function
Time frame: week 6, month 3, month 6 and month12
PROMIS-29 Subscale--Physical Function: Anxiety
Time frame: week 6, month 3, month 6 and month12
PROMIS-29 Subscale--Depression
Time frame: week 6, month 3, month 6 and month12
PROMIS-29 Subscale--Fatigue
Time frame: week 6, month 3, month 6 and month12
PROMIS-29 Subscale--Sleep Disturbance
Time frame: week 6, month 3, month 6 and month12
PROMIS-29 Subscale--Pain Interference
Time frame: week 6, month 3, month 6 and month12
PROMIS-29 Subscale--Ability to Participate in Social Roles and Activities
Time frame: week 6, month 3, month 6 and month12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Results publication: PubMed 17414553Owens BD, Kragh JF Jr, Macaitis J, Svoboda SJ, Wenke JC. Characterization of extremity wounds in Operation Iraqi Freedom and Operation Enduring Freedom. J Orthop Trauma. 2007 Apr;21(4):254-7. doi: 10.1097/BOT.0b013e31802f78fb.
- Results publication: PubMed 22491628Burns TC, Stinner DJ, Mack AW, Potter BK, Beer R, Eckel TT, Possley DR, Beltran MJ, Hayda RA, Andersen RC, Keeling JJ, Frisch HM, Murray CK, Wenke JC, Ficke JR, Hsu JR; Skeletal Trauma Research Consortium. Microbiology and injury characteristics in severe open tibia fractures from combat. J Trauma Acute Care Surg. 2012 Apr;72(4):1062-7. doi: 10.1097/TA.0b013e318241f534.
- Results publication: PubMed 12477942Bosse MJ, MacKenzie EJ, Kellam JF, Burgess AR, Webb LX, Swiontkowski MF, Sanders RW, Jones AL, McAndrew MP, Patterson BM, McCarthy ML, Travison TG, Castillo RC. An analysis of outcomes of reconstruction or amputation after leg-threatening injuries. N Engl J Med. 2002 Dec 12;347(24):1924-31. doi: 10.1056/NEJMoa012604.
- Results publication: PubMed 25159355Napierala MA, Rivera JC, Burns TC, Murray CK, Wenke JC, Hsu JR; Skeletal Trauma Research Education Consortium (STReC). Infection reduces return-to-duty rates for soldiers with Type III open tibia fractures. J Trauma Acute Care Surg. 2014 Sep;77(3 Suppl 2):S194-7. doi: 10.1097/TA.0000000000000364.
- Results publication: PubMed 17638186Johnson EN, Burns TC, Hayda RA, Hospenthal DR, Murray CK. Infectious complications of open type III tibial fractures among combat casualties. Clin Infect Dis. 2007 Aug 15;45(4):409-15. doi: 10.1086/520029. Epub 2007 Jul 5.
- Results publication: PubMed 17916782Ficke JR, Pollak AN. Extremity War Injuries: Development of Clinical Treatment Principles. J Am Acad Orthop Surg. 2007 Oct;15(10):590-5. doi: 10.5435/00124635-200710000-00003.
- Results publication: PubMed 28323794Section 1: Preventing and Managing Infection and Other Complications After Orthopaedic Trauma. J Orthop Trauma. 2017 Apr;31 Suppl 1:S2. doi: 10.1097/BOT.0000000000000798. No abstract available.
- Results publication: PubMed 21795886Masini BD, Owens BD, Hsu JR, Wenke JC. Rehospitalization after combat injury. J Trauma. 2011 Jul;71(1 Suppl):S98-102. doi: 10.1097/TA.0b013e3182218fbc.
- Results publication: PubMed 21795878Huh J, Stinner DJ, Burns TC, Hsu JR; Late Amputation Study Team. Infectious complications and soft tissue injury contribute to late amputation after severe lower extremity trauma. J Trauma. 2011 Jul;71(1 Suppl):S47-51. doi: 10.1097/TA.0b013e318221181d.
- Results publication: PubMed 21885998Cross JD, Stinner DJ, Burns TC, Wenke JC, Hsu JR; Skeletal Trauma Research Consortium (STReC). Return to duty after type III open tibia fracture. J Orthop Trauma. 2012 Jan;26(1):43-7. doi: 10.1097/BOT.0b013e31821c0ec1.
- Results publication: PubMed 15227616Bratzler DW, Houck PM; Surgical Infection Prevention Guidelines Writers Workgroup; American Academy of Orthopaedic Surgeons; American Association of Critical Care Nurses; American Association of Nurse Anesthetists; American College of Surgeons; American College of Osteopathic Surgeons; American Geriatrics Society; American Society of Anesthesiologists; American Society of Colon and Rectal Surgeons; American Society of Health-System Pharmacists; American Society of PeriAnesthesia Nurses; Ascension Health; Association of periOperative Registered Nurses; Association for Professionals in Infection Control and Epidemiology; Infectious Diseases Society of America; Medical Letter; Premier; Society for Healthcare Epidemiology of America; Society of Thoracic Surgeons; Surgical Infection Society. Antimicrobial prophylaxis for surgery: an advisory statement from the National Surgical Infection Prevention Project. Clin Infect Dis. 2004 Jun 15;38(12):1706-15. doi: 10.1086/421095. Epub 2004 May 26.
- Results publication: PubMed 31443939Pinto D, Manjunatha K, Savur AD, Ahmed NR, Mallya S, Ramya V. Comparative study of the efficacy of gentamicin-coated intramedullary interlocking nail versus regular intramedullary interlocking nail in Gustilo type I and II open tibia fractures. Chin J Traumatol. 2019 Oct;22(5):270-273. doi: 10.1016/j.cjtee.2019.03.006. Epub 2019 Jun 21.
- Individual participant dataSharing planned: No
Related trials for Osteomyelitis Tibia
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joseph Hsu, MD principal investigator
Wake Forest University Health Sciences
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Antibiotic coated intramedullary Nail and Standard Intramedullary Nail in people with Osteomyelitis Tibia and Tibial Fractures, run by Wake Forest University Health Sciences at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rachel Seymour, PhD (7043552000, Rachel.Seymour@advocatehealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants who develop deep surgical site infection (SSI) (time frame: Day 30 through month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05421741, which also lists 38 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.