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

NCT06280417 | Not Yet Recruiting

• 1 other identifier: Unreamed IMN In IIIa tibia
• Study Type: observational
• Target: 25
• Locations: 0 countries
• Sites: N/A

Brief 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 .

Conditions

Tibia Fracture

Outcome Measures

Primary Outcomes (1)

• Incidence of non union

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

  Baseline

Secondary Outcomes (3)

• Incidince of fracture related infection

  Baseline

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

  Baseline

• functional evaluation

  Baseline

Interventions

Unreamed intramedullary tibial nail DEVICE

Fixation of type IIIa tibial fractures by unreamed IMN

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (13)

• 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.

  PMID: 19047701 BACKGROUND

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

  PMID: 4609655 BACKGROUND

• 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.

  PMID: 9447512 BACKGROUND

• 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.

  PMID: 3365903 BACKGROUND

• 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.

  PMID: 2924483 BACKGROUND

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

  PMID: 3733776 BACKGROUND

• 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.

  PMID: 15091267 BACKGROUND

• 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.

  PMID: 6471139 BACKGROUND

• 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.

  PMID: 7869165 BACKGROUND

• 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.

  PMID: 15621910 BACKGROUND

• 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.

  PMID: 37666261 BACKGROUND

• 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.

  PMID: 30143702 BACKGROUND

• 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.

  PMID: 21936253 BACKGROUND

MeSH Terms

Conditions

Tibial Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries

Central Study Contacts

Mina Ramzy Roshdy

CONTACT

+201553136976; menaramzy@med.aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: February 20, 2024
• First Posted: February 28, 2024
• Study Start: June 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: August 1, 2025
• Last Updated: February 28, 2024

Record last verified: 2024-02