Primary Dynamization Versus Standard Interlocking Intramedullary Nail in Treatment of Tibial Shaft Fractures in Adults

NCT ID: NCT06147219

Last Updated: 2023-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-01

Study Completion Date

2024-09-01

Brief Summary

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fracture shfat tibia in adults treated by interlocking intramedullary nail by primary dynamic versus standard ways

Detailed Description

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Conditions

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Tibial Shaft Fractures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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primary dynamization interlocking intramedullary tibial nail

Group Type ACTIVE_COMPARATOR

interlocking intramedullary tibial nail

Intervention Type PROCEDURE

primary dynamization versus standard interlocking intramedullary tibial nail

standard interlocking intramedullary tibial nail

Group Type ACTIVE_COMPARATOR

interlocking intramedullary tibial nail

Intervention Type PROCEDURE

primary dynamization versus standard interlocking intramedullary tibial nail

Interventions

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interlocking intramedullary tibial nail

primary dynamization versus standard interlocking intramedullary tibial nail

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* adult patients (18-50) fractures with mid shaft or distal shaft tibial fracture AO type A1, A2 and A3 and minimal soft tisuue damage

Exclusion Criteria

* patients with comminuted fractures , old age more than 50 years , sclerotic bone , osteoporosis, osteopetrosis and bone deformity
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Salah Hafez

Resident of Orthopaedic department, Sohag University Hospitals

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sohag University hospitals

Sohag, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Mohamed Sh Hafez, Resident

Role: CONTACT

01159638667

Abd el-rahman Hz Khalefa

Role: CONTACT

Facility Contacts

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Magdy M Amin, Professor

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 19996801 (View on PubMed)

Fracture and dislocation compendium. Orthopaedic Trauma Association Committee for Coding and Classification. J Orthop Trauma. 1996;10 Suppl 1:v-ix, 1-154. No abstract available.

Reference Type BACKGROUND
PMID: 8814583 (View on PubMed)

Omerovic D, Lazovic F, Hadzimehmedagic A. Static or dynamic intramedullary nailing of femur and tibia. Med Arch. 2015 Apr;69(2):110-3. doi: 10.5455/medarh.2015.69.110-113. Epub 2015 Apr 6.

Reference Type BACKGROUND
PMID: 26005261 (View on PubMed)

Vaughn J, Gotha H, Cohen E, Fantry AJ, Feller RJ, Van Meter J, Hayda R, Born CT. Nail Dynamization for Delayed Union and Nonunion in Femur and Tibia Fractures. Orthopedics. 2016 Nov 1;39(6):e1117-e1123. doi: 10.3928/01477447-20160819-01. Epub 2016 Aug 30.

Reference Type BACKGROUND
PMID: 27575039 (View on PubMed)

Other Identifiers

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Soh-Med-23-010-04

Identifier Type: -

Identifier Source: org_study_id