- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06280417
Unreamed Intramedullary Tibial Nailing in Treatment of Open IIIa Diaphyseal Tibial Fractures in Adults
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Tibia is one of the most common bones to sustain open injury because of its superficial nature.Concerns over the high rates of malunion, nonunion, and deep infection have resulted in the development of aggressive treatment protocols including emergent wound exploration, thorough irrigation and debridement, bony stabilization, judicious antibiotic therapy, repeated wound debridements, and early soft-tissue coverage. However, there is still controversy regarding the optimal method of skeletal stabilization. High rates of pin tract infections, poor patient compliance, and malunion rates of 20% and greater have limited the use of external fixators as a definitive form of fixation.Despite initial encouraging results, plate fixation of open tibial fractures has been associated with implant failures, nonunions, and deep infection rates as high as 35%.6As a result, locked intramedullary nailing has become the standard treatment for open tibia fractures enabling axial alignment, early weight bearing, and immediate knee and ankle motion. Despite this, the complications including a high incidence of local bony necrosis and sepsis that occur following reamed intramedullary nails have led some to discourage the use of this method of skeletal stabilization in open tibia fractures.intramedullary tibial nail insertion without reaming has the advantage of minimal endosteal blood supply disruption and thus supposed to have increased union rate and reduction of infection rate .
Sanders et al 11 reported on the treatment of 64 patients with open tibial shaft fractures using unreamed interlocked intramedullary nails. All but 1 of the fractures healed with excellent alignment and an overall chronic infection rate of 4%.other studies reported similar results .12 type and timing of fixation were important determinants of infection , with people who received intramedullary nailing within 24 h having the lowest risk of infection .UTN significantly reduced the incidence rates of superficial infection and malunion compared with EF, suggesting that it is likely a safe and effective alternative to EF for treating open tibial fractures. however patients' postoperative weight bearing should be controlled to avoid hardware failure.
Here,our purpose is to investigate the outcome of Unreamed intramedullary nail in open diaphyseal fractures of the tibia in our setup .
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Mina Ramzy Roshdy
- Phone Number: +201553136976
- Email: menaramzy@med.aun.edu.eg
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Open grade IIIa diaphyseal tibial fractures .
- Skeletaly mature patients .
Exclusion Criteria:
- late presentation and open infected fractures .
- Associated intraarticular fractures of proximal /distal tibia.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of non union
Time Frame: Baseline
|
Preoperative and postoperative x-ray anteroposterior & lateral views including both ankle and knee joints
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidince of fracture related infection
Time Frame: Baseline
|
Culture and sensitivity and blood tests
|
Baseline
|
The rate of reoperation for delayed union or non-union , infection and fasciotomy
Time Frame: Baseline
|
Baseline
|
|
functional evaluation
Time Frame: Baseline
|
Modified Karlstrom- Olerud Score
|
Baseline
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Gustilo RB, Mendoza RM, Williams DN. Problems in the management of type III (severe) open fractures: a new classification of type III open fractures. J Trauma. 1984 Aug;24(8):742-6. doi: 10.1097/00005373-198408000-00009.
- Sanders R, Jersinovich I, Anglen J, DiPasquale T, Herscovici D Jr. The treatment of open tibial shaft fractures using an interlocked intramedullary nail without reaming. J Orthop Trauma. 1994 Dec;8(6):504-10.
- Study to Prospectively Evaluate Reamed Intramedullary Nails in Patients with Tibial Fractures Investigators; Bhandari M, Guyatt G, Tornetta P 3rd, Schemitsch EH, Swiontkowski M, Sanders D, Walter SD. Randomized trial of reamed and unreamed intramedullary nailing of tibial shaft fractures. J Bone Joint Surg Am. 2008 Dec;90(12):2567-78. doi: 10.2106/JBJS.G.01694.
- Rhinelander FW. Tibial blood supply in relation to fracture healing. Clin Orthop Relat Res. 1974 Nov-Dec;(105):34-81. No abstract available.
- Henley MB, Chapman JR, Agel J, Harvey EJ, Whorton AM, Swiontkowski MF. Treatment of type II, IIIA, and IIIB open fractures of the tibial shaft: a prospective comparison of unreamed interlocking intramedullary nails and half-pin external fixators. J Orthop Trauma. 1998 Jan;12(1):1-7. doi: 10.1097/00005131-199801000-00001.
- Edwards CC, Simmons SC, Browner BD, Weigel MC. Severe open tibial fractures. Results treating 202 injuries with external fixation. Clin Orthop Relat Res. 1988 May;(230):98-115.
- Bach AW, Hansen ST Jr. Plates versus external fixation in severe open tibial shaft fractures. A randomized trial. Clin Orthop Relat Res. 1989 Apr;(241):89-94.
- Bone LB, Johnson KD. Treatment of tibial fractures by reaming and intramedullary nailing. J Bone Joint Surg Am. 1986 Jul;68(6):877-87.
- Larsen LB, Madsen JE, Hoiness PR, Ovre S. Should insertion of intramedullary nails for tibial fractures be with or without reaming? A prospective, randomized study with 3.8 years' follow-up. J Orthop Trauma. 2004 Mar;18(3):144-9. doi: 10.1097/00005131-200403000-00003.
- Joshi D, Ahmed A, Krishna L, Lal Y. Unreamed interlocking nailing in open fractures of tibia. J Orthop Surg (Hong Kong). 2004 Dec;12(2):216-21. doi: 10.1177/230949900401200215.
- Schade AT, Sabawo M, Nyamulani N, Mpanga CC, Ngoie LB, Metcalfe AJ, Lalloo DG, Madan JJ, Harrison WJ, MacPherson P. Functional outcomes and quality of life at 1-year follow-up after an open tibia fracture in Malawi: a multicentre, prospective cohort study. Lancet Glob Health. 2023 Oct;11(10):e1609-e1618. doi: 10.1016/S2214-109X(23)00346-7. Epub 2023 Sep 1.
- Fu Q, Zhu L, Lu J, Ma J, Chen A. External Fixation versus Unreamed Tibial Intramedullary Nailing for Open Tibial Fractures: A Meta-analysis of Randomized Controlled Trials. Sci Rep. 2018 Aug 24;8(1):12753. doi: 10.1038/s41598-018-30716-y.
- Mohseni MA, Soleimanpour J, Mohammadpour H, Shahsavari A. AO tubular external fixation vs. unreamed intramedullary nailing in open grade IIIA-IIIB tibial shaft fractures: a single-center randomized clinical trial. Pak J Biol Sci. 2011 Apr 15;14(8):490-5. doi: 10.3923/pjbs.2011.490.495.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Unreamed IMN In IIIa tibia
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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