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Tibia FractureNCT06280417

Unreamed Intramedullary Tibial Nailing in Treatment of Open IIIa Diaphyseal Tibial Fractures in Adults

An observational study of Tibia Fracture, run by Assiut University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

To study the incidence of non union of Unreamed intramedullary nailing in type IIIa Open diaphyseal fractures of the tibia as a primary outcome and the incidence of complications and clinical and functional outcome as a secondary outcome . Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Tibia Fracture
What is being tested?
Unreamed intramedullary tibial nail
Type of treatment
Medical device
How many people
25 participants
Where
No sites listed yet
Study dates
1 Jun 2024to 1 Aug 2025
Phase
Observational
Are there results?
None posted in the registry

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

Study population: Adult patients presenting with type IIIa diaphyseal tibial fractures are included in the study

Who may be able to join

  • Open grade IIIa diaphyseal tibial fractures .
  • Skeletaly mature patients .

Who cannot join

  • late presentation and open infected fractures .
  • Associated intraarticular fractures of proximal /distal tibia.

Trial locations and contacts

No sites are listed yet.

Mina Ramzy Roshdy contact

+201553136976

menaramzy@med.aun.edu.eg

About this study

To study the incidence of non union of Unreamed intramedullary nailing in type IIIa Open diaphyseal fractures of the tibia as a primary outcome and the incidence of complications and clinical and functional outcome as a secondary outcome .

Read the 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 .

Conditions
Tibia Fracture
Being tested
Unreamed intramedullary tibial 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.

  • Unreamed intramedullary tibial nailDevice

    Fixation of type IIIa tibial fractures by unreamed IMN

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of non union

    Preoperative and postoperative x-ray anteroposterior \& lateral views including both ankle and knee joints

    Measured: Baseline

Secondary outcomes (3)

  1. Incidince of fracture related infection

    Culture and sensitivity and blood tests

    Measured: Baseline

  2. The rate of reoperation for delayed union or non-union , infection and fasciotomy

    Measured: Baseline

  3. functional evaluation

    Modified Karlstrom- Olerud Score

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2024
  2. Study start1 Jun 2024 (estimated)
  3. Primary completion1 Jun 2025 (estimated)
  4. Study completion1 Aug 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
25 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06280417
Sponsor's protocol ID
Unreamed IMN In IIIa tibia
Status last verified
Feb 2024
First submitted
20 Feb 2024
Last updated
28 Feb 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 19047701

  • Rhinelander FW. Tibial blood supply in relation to fracture healing. Clin Orthop Relat Res. 1974 Nov-Dec;(105):34-81. No abstract available.

    PubMed 4609655

  • 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.

    PubMed 9447512

  • 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.

    PubMed 3365903

  • 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.

    PubMed 2924483

  • Bone LB, Johnson KD. Treatment of tibial fractures by reaming and intramedullary nailing. J Bone Joint Surg Am. 1986 Jul;68(6):877-87.

    PubMed 3733776

  • 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.

    PubMed 15091267

  • 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.

    PubMed 6471139

  • 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.

    PubMed 7869165

  • 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.

    PubMed 15621910

  • 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.

    PubMed 37666261

  • 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.

    PubMed 30143702

  • 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.

    PubMed 21936253

Questions about this trial

What is this clinical trial studying?

An observational study of Tibia Fracture, run by Assiut University.

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 2 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: status not confirmed, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

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.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Mina Ramzy Roshdy (+201553136976, menaramzy@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of non union (time frame: Baseline). 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 NCT06280417, which also lists 13 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 28 Feb 2024.

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