NCT05421741

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
484

participants targeted

Target at P75+ for phase_4

Timeline
19mo left

Started May 2023

Longer than P75 for phase_4

Geographic Reach
1 country

14 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress66%
May 2023Dec 2027

First Submitted

Initial submission to the registry

June 13, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 16, 2022

Completed
11 months until next milestone

Study Start

First participant enrolled

May 15, 2023

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

March 18, 2026

Status Verified

June 1, 2025

Enrollment Period

3.6 years

First QC Date

June 13, 2022

Last Update Submit

March 17, 2026

Conditions

Osteomyelitis TibiaTibial FracturesOpen Tibia Fracture

Keywords

Antibiotic-coated nail

Outcome Measures

Primary Outcomes (1)

  • 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.

    Day 30 through month 12

Secondary Outcomes (14)

  • Radiographic Union Scale in Tibial fractures (RUST) score

    week 6, month 3, month 6, and month 12

  • Percentage of Union

    week 6, month 3, month 6 and month12

  • Time to Union

    week 6, month 3, month 6 and month12

  • Average Time to Return to Work/Duty

    week 6, month 3, month 6 and month12

  • International Physical Activity Questionnaire (IPAQ)

    week 6, month 3, month 6 and month12

  • +9 more secondary outcomes

Study Arms (2)

Intramedullary Nail

ACTIVE COMPARATOR

Traditional standard of care intramedullary (IM) nail

Other: Standard Intramedullary Nail

Antibiotic Coated Intramedullary Nail

ACTIVE COMPARATOR

Intramedullary Nail coated with 2 grams of vancomycin and 560 mg gentamicin liquid.

Drug: Antibiotic coated intramedullary Nail

Interventions

Antibiotic coated intramedullary NailDRUG

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.

Also known as: Local Gentamicin 560 Powder, Vancomycin 2gm Liquid
Antibiotic Coated Intramedullary Nail
Standard Intramedullary NailOTHER

Standard Intramedullary Nail

Intramedullary Nail

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients 18 years or older
  • Gustilo Type II or III open tibia fracture requiring definitive fixation with intramedullary nail

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

University of Florida Gainesville

Gainesville, Florida, 32607, United States

RECRUITING

Florida Orthopaedic Institute

Temple Terrace, Florida, 33637, United States

RECRUITING

Atrium Health Navicent

Macon, Georgia, 31201, United States

RECRUITING

University of Kentucky

Lexington, Kentucky, 40536, United States

RECRUITING

University of North Carolina Chapel Hill

Chapel Hill, North Carolina, 27546, United States

RECRUITING

Atrium Health Carolinas Medical Center

Charlotte, North Carolina, 28203, United States

RECRUITING

Atrium Health Cabarrus

Concord, North Carolina, 28025, United States

RECRUITING

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, 27157, United States

RECRUITING

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

RECRUITING

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

RECRUITING

University of Texas Houston

Houston, Texas, 77030, United States

RECRUITING

San Antonio Military Medical Center

San Antonio, Texas, 78234, United States

RECRUITING

Carilion Clinic

Roanoke, Virginia, 24016, United States

NOT YET RECRUITING

Valley Health System

Winchester, Virginia, 22601, United States

RECRUITING

Related Publications (38)

  • 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.

    PMID: 17414553RESULT

  • Burns 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.

    PMID: 22491628RESULT

  • Bosse 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.

    PMID: 12477942RESULT

  • Napierala 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.

    PMID: 25159355RESULT

  • Johnson 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.

    PMID: 17638186RESULT

  • Ficke 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.

    PMID: 17916782RESULT

  • Section 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.

    PMID: 28323794RESULT

  • Masini 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.

    PMID: 21795886RESULT

  • Huh 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.

    PMID: 21795878RESULT

  • Cross 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.

    PMID: 21885998RESULT

  • Bratzler 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.

    PMID: 15227616RESULT

  • Pinto 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.

    PMID: 31443939RESULT

  • Schmidmaier 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.

    PMID: 28734495RESULT

  • Jorge-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.

    PMID: 31555500RESULT

  • Shiels 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.

    PMID: 31995226RESULT

  • Lin WT, Tan HL, Duan ZL, Yue B, Ma R, He G, Tang TT. Inhibited bacterial biofilm formation and improved osteogenic activity on gentamicin-loaded titania nanotubes with various diameters. Int J Nanomedicine. 2014 Mar 7;9:1215-30. doi: 10.2147/IJN.S57875. eCollection 2014.

    PMID: 24634583RESULT

  • Mauffrey C, Butler N, Hake ME. Fabrication of an Interlocked Antibiotic/Cement-Coated Carbon Fiber Nail for the Treatment of Long Bone Osteomyelitis. J Orthop Trauma. 2016 Aug;30 Suppl 2:S23-4. doi: 10.1097/BOT.0000000000000587.

    PMID: 27441930RESULT

  • Thonse R, Conway J. Antibiotic cement-coated interlocking nail for the treatment of infected nonunions and segmental bone defects. J Orthop Trauma. 2007 Apr;21(4):258-68. doi: 10.1097/BOT.0b013e31803ea9e6.

    PMID: 17414554RESULT

  • Barger J, Fragomen AT, Rozbruch SR. Antibiotic-Coated Interlocking Intramedullary Nail for the Treatment of Long-Bone Osteomyelitis. JBJS Rev. 2017 Jul;5(7):e5. doi: 10.2106/JBJS.RVW.16.00095. No abstract available.

    PMID: 28719401RESULT

  • O'Toole R, Joshi M, Carlini A, et al. Multicenter Randomized Trial Evaluating Intrawound Vancomycin Powder for Reducing Surgical Site Infection After Fracture Surgery. Orthopaedic Trauma Association; 2018; Orlando, FL

    RESULT

  • Caroom C, Tullar JM, Benton EG Jr, Jones JR, Chaput CD. Intrawound vancomycin powder reduces surgical site infections in posterior cervical fusion. Spine (Phila Pa 1976). 2013 Jun 15;38(14):1183-7. doi: 10.1097/BRS.0b013e31828fcfb5.

    PMID: 23474597RESULT

  • Carver DC, Kuehn SB, Weinlein JC. Role of Systemic and Local Antibiotics in the Treatment of Open Fractures. Orthop Clin North Am. 2017 Apr;48(2):137-153. doi: 10.1016/j.ocl.2016.12.005. Epub 2017 Jan 30.

    PMID: 28336038RESULT

  • O'Toole RV, Joshi M, Carlini AR, Murray CK, Allen LE, Scharfstein DO, Gary JL, Bosse MJ, Castillo RC; METRC. Local Antibiotic Therapy to Reduce Infection After Operative Treatment of Fractures at High Risk of Infection: A Multicenter, Randomized, Controlled Trial (VANCO Study). J Orthop Trauma. 2017 Apr;31 Suppl 1:S18-S24. doi: 10.1097/BOT.0000000000000801.

    PMID: 28323797RESULT

  • Hanssen AD, Osmon DR, Patel R. Local antibiotic delivery systems: where are we and where are we going? Clin Orthop Relat Res. 2005 Aug;(437):111-4. No abstract available.

    PMID: 16056035RESULT

  • Shiels SM, Tennent DJ, Lofgren AL, Wenke JC. Topical rifampin powder for orthopaedic trauma part II: Topical rifampin allows for spontaneous bone healing in sterile and contaminated wounds. J Orthop Res. 2018 Dec;36(12):3142-3150. doi: 10.1002/jor.24155. Epub 2018 Oct 29.

    PMID: 30270538RESULT

  • Tennent DJ, Shiels SM, Sanchez CJ Jr, Niece KL, Akers KS, Stinner DJ, Wenke JC. Time-Dependent Effectiveness of Locally Applied Vancomycin Powder in a Contaminated Traumatic Orthopaedic Wound Model. J Orthop Trauma. 2016 Oct;30(10):531-7. doi: 10.1097/BOT.0000000000000617.

    PMID: 27124826RESULT

  • Shiels SM, Tennent DJ, Wenke JC. Topical rifampin powder for orthopedic trauma part I: Rifampin powder reduces recalcitrant infection in a delayed treatment musculoskeletal trauma model. J Orthop Res. 2018 Dec;36(12):3136-3141. doi: 10.1002/jor.24055. Epub 2018 Oct 5.

    PMID: 29781552RESULT

  • Berger ML, Dreyer N, Anderson F, Towse A, Sedrakyan A, Normand SL. Prospective observational studies to assess comparative effectiveness: the ISPOR good research practices task force report. Value Health. 2012 Mar-Apr;15(2):217-30. doi: 10.1016/j.jval.2011.12.010.

    PMID: 22433752RESULT

  • Dreyer NA, Tunis SR, Berger M, Ollendorf D, Mattox P, Gliklich R. Why observational studies should be among the tools used in comparative effectiveness research. Health Aff (Millwood). 2010 Oct;29(10):1818-25. doi: 10.1377/hlthaff.2010.0666.

    PMID: 20921481RESULT

  • Centers for Disease Control and Prevention. Surgical Site Infection (SSI) Event, January 2018. National Healthcare Safety Network. 2018

    RESULT

  • Berrios-Torres SI, Umscheid CA, Bratzler DW, Leas B, Stone EC, Kelz RR, Reinke CE, Morgan S, Solomkin JS, Mazuski JE, Dellinger EP, Itani KMF, Berbari EF, Segreti J, Parvizi J, Blanchard J, Allen G, Kluytmans JAJW, Donlan R, Schecter WP; Healthcare Infection Control Practices Advisory Committee. Centers for Disease Control and Prevention Guideline for the Prevention of Surgical Site Infection, 2017. JAMA Surg. 2017 Aug 1;152(8):784-791. doi: 10.1001/jamasurg.2017.0904.

    PMID: 28467526RESULT

  • Whelan DB, Bhandari M, Stephen D, Kreder H, McKee MD, Zdero R, Schemitsch EH. Development of the radiographic union score for tibial fractures for the assessment of tibial fracture healing after intramedullary fixation. J Trauma. 2010 Mar;68(3):629-32. doi: 10.1097/TA.0b013e3181a7c16d.

    PMID: 19996801RESULT

  • Kooistra BW, Dijkman BG, Busse JW, Sprague S, Schemitsch EH, Bhandari M. The radiographic union scale in tibial fractures: reliability and validity. J Orthop Trauma. 2010 Mar;24 Suppl 1:S81-6. doi: 10.1097/BOT.0b013e3181ca3fd1.

    PMID: 20182243RESULT

  • Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.

    PMID: 12900694RESULT

  • Cella D, Riley W, Stone A, Rothrock N, Reeve B, Yount S, Amtmann D, Bode R, Buysse D, Choi S, Cook K, Devellis R, DeWalt D, Fries JF, Gershon R, Hahn EA, Lai JS, Pilkonis P, Revicki D, Rose M, Weinfurt K, Hays R; PROMIS Cooperative Group. The Patient-Reported Outcomes Measurement Information System (PROMIS) developed and tested its first wave of adult self-reported health outcome item banks: 2005-2008. J Clin Epidemiol. 2010 Nov;63(11):1179-94. doi: 10.1016/j.jclinepi.2010.04.011. Epub 2010 Aug 4.

    PMID: 20685078RESULT

  • Cella D, Yount S, Rothrock N, Gershon R, Cook K, Reeve B, Ader D, Fries JF, Bruce B, Rose M; PROMIS Cooperative Group. The Patient-Reported Outcomes Measurement Information System (PROMIS): progress of an NIH Roadmap cooperative group during its first two years. Med Care. 2007 May;45(5 Suppl 1):S3-S11. doi: 10.1097/01.mlr.0000258615.42478.55.

    PMID: 17443116RESULT

  • Schalet BD, Rothrock NE, Hays RD, Kazis LE, Cook KF, Rutsohn JP, Cella D. Linking Physical and Mental Health Summary Scores from the Veterans RAND 12-Item Health Survey (VR-12) to the PROMIS((R)) Global Health Scale. J Gen Intern Med. 2015 Oct;30(10):1524-30. doi: 10.1007/s11606-015-3453-9. Epub 2015 Jul 16.

    PMID: 26179820RESULT

  • Selim AJ, Rogers W, Fleishman JA, Qian SX, Fincke BG, Rothendler JA, Kazis LE. Updated U.S. population standard for the Veterans RAND 12-item Health Survey (VR-12). Qual Life Res. 2009 Feb;18(1):43-52. doi: 10.1007/s11136-008-9418-2. Epub 2008 Dec 3.

    PMID: 19051059RESULT

MeSH Terms

Conditions

Tibial Fractures

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesLeg Injuries

Study Officials

  • Joseph Hsu, MD

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachel Seymour, PhD

CONTACT

7043552000Rachel.Seymour@advocatehealth.org

Christine Churchill, MA

CONTACT

7043552000Christine.Churchill@advocatehealth.org

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2022

First Posted

June 16, 2022

Study Start

May 15, 2023

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2027

Last Updated

March 18, 2026

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

US(14)