Tibial Shaft FracturesNCT06147219
Primary Dynamization Versus Standard Interlocking Intramedullary Nail in Treatment of Tibial Shaft Fractures in Adults
A study testing interlocking intramedullary tibial nail in people with Tibial Shaft Fractures, run by Sohag University at 1 site in Egypt.
Trial summary
fracture shfat tibia in adults treated by interlocking intramedullary nail by primary dynamic versus standard ways Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Tibial Shaft Fractures
- What is being tested?
- interlocking intramedullary tibial nail
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2023to 1 Sep 2024
- Phase
- Interventional
- 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 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- adult patients (18-50) fractures with mid shaft or distal shaft tibial fracture AO type A1, A2 and A3 and minimal soft tisuue damage
Who cannot join
- patients with comminuted fractures , old age more than 50 years , sclerotic bone , osteoporosis, osteopetrosis and bone deformity
Trial locations and contacts
1 site in 1 country.
Abd el-rahman Hz Khalefa contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag University hospitals
Sohag
Magdy M Amin, Professor
About this study
fracture shfat tibia in adults treated by interlocking intramedullary nail by primary dynamic versus standard ways
- Conditions
- Tibial Shaft Fractures
- Being tested
- interlocking intramedullary tibial nail
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interlocking intramedullary tibial nailProcedure or surgery
primary dynamization versus standard interlocking intramedullary tibial nail
| Study group | Role | What they receive |
|---|---|---|
| primary dynamization interlocking intramedullary tibial nail | Active comparator | Not described Receives: Procedure: interlocking intramedullary tibial nail |
| standard interlocking intramedullary tibial nail | Active comparator | Not described Receives: Procedure: interlocking intramedullary tibial nail |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Dynamization Interlocking Intramedullary Tibial Nail
use only distal screws away from fracture site
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2023
- Study start1 Sep 2023
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Tibial Shaft FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Salah Hafez, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06147219
- Sponsor's protocol ID
- Soh-Med-23-010-04
- Status last verified
- Nov 2023
- First submitted
- 19 Nov 2023
- Last updated
- 27 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 19996801Fracture 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.
PubMed 8814583Omerovic 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.
PubMed 26005261Vaughn 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.
PubMed 27575039Elsayed M, Khalefa AH, Mazen MSH, Ahmed KFE. Primary dynamization versus standard static interlocking nailing in treatment of tibial shaft fractures in adults: a randomized controlled trial. BMC Musculoskelet Disord. 2025 Dec 12;27(1):42. doi: 10.1186/s12891-025-09376-3.
PubMed 41387845
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Dynamization Versus Standard Interlocking Intramedullary Nail in Treatment of Tibial Shaft Fractures in Adults
- ClinicalTrials.gov ID
- NCT06147219
- Acronym / sponsor ID
- Soh-Med-23-010-04
- Conditions
- Tibial Shaft Fractures
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 27 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
fracture shfat tibia in adults treated by interlocking intramedullary nail by primary dynamic versus standard ways
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| primary dynamization interlocking intramedullary tibial nail | Active comparator | Procedure: interlocking intramedullary tibial nail |
| standard interlocking intramedullary tibial nail | Active comparator | Procedure: interlocking intramedullary tibial nail |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- adult patients (18-50) fractures with mid shaft or distal shaft tibial fracture AO type A1, A2 and A3 and minimal soft tisuue damage
Key exclusion criteria (1 listed)
- patients with comminuted fractures , old age more than 50 years , sclerotic bone , osteoporosis, osteopetrosis and bone deformity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| interlocking intramedullary tibial nailprimary dynamization versus standard interlocking intramedullary tibial nail | Procedure or surgery | primary dynamization interlocking intramedullary tibial nail, standard interlocking intramedullary tibial nail |
Primary outcome
Primary Dynamization Interlocking Intramedullary Tibial Nail
Time frame: 12 months
use only distal screws away from fracture site
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2023.
- Background: PubMed 19996801Whelan 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.
- Background: PubMed 8814583Fracture 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.
- Background: PubMed 26005261Omerovic 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.
- Background: PubMed 27575039Vaughn 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.
- Derived from this study: PubMed 41387845Elsayed M, Khalefa AH, Mazen MSH, Ahmed KFE. Primary dynamization versus standard static interlocking nailing in treatment of tibial shaft fractures in adults: a randomized controlled trial. BMC Musculoskelet Disord. 2025 Dec 12;27(1):42. doi: 10.1186/s12891-025-09376-3.
- Individual participant dataSharing planned: Undecided
Related trials for Tibial Shaft Fractures
Recruiting
MY01 Pressure Monitoring in Adolescent Tibia Fractures
Proximal Tibia Fracture, Tibial Shaft Fracture
RecruitingObservational study
Comparison of Knee Muscle Function After Suprapatellar and Infrapatellar Tibial Nailing in Patients With Tibial Shaft Fractures
Tibia Fractures
Active, not recruitingObservational study
Anterior Knee Pain and Patellar Tendon Elasticity After Infrapatellar Tendon-Split Tibial Intramedullary Nailing
Anterior Knee Pain, Patellar Tendon Disorder
Not yet recruiting
Rehabilitation After Lower Extremity Nailing Trial
Femoral Shaft Fracture, Tibial Shaft Fractures
Recruiting
Comparison of Functional Recovery Following Medial Parapatellar and Transpatellar Approaches for Intramedullary Nailing of Tibial Shaft Fractures
Tibial Shaft Fractures
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abd el-rahman Hz Khalefa contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing interlocking intramedullary tibial nail in people with Tibial Shaft Fractures, run by Sohag University at 1 site in Egypt.
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 1 inclusion and 1 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 27 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Mohamed Sh Hafez, Resident (01159638667, mohamedhafez@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Dynamization Interlocking Intramedullary Tibial Nail (time frame: 12 months). 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 NCT06147219, which also lists 5 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 27 Nov 2023.