Forearm FracturesNCT07705347
Management of Diaphyseal Forearm Fractures in Adolescents
A study testing Open reduction and internal fixation and Closed or mini-open reduction and fixation in people with Forearm Fractures, run by Sohag University at 1 site in Egypt.
Trial summary
evaluate and compare the clinical, and radiographic outcomes of 2.7 mm locking compression mini-plate osteosynthesis versus titanium elastic intramedullary nail (TEN) in the surgical management of diaphyseal fractures of both forearm bones in adolescent patients Read more about this study
- Who is it for?
- Ages 10 to 16 years
- Conditions the study is for
- Forearm Fractures
- What is being tested?
- Open reduction and internal fixation and Closed or mini-open reduction and fixation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jul 2026to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 10 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age: 10 to 16 years (at time of injury).
- Fracture pattern: diaphyseal fracture involving both the radius or ulna.
- o Fracture location: Diaphysis defined as the segment between the proximal metaphyseal flare (distal to bicipital tuberosity for radius; distal to coronoid process for ulna) and the distal metaphyseal flare (within 3 cm of the distal physis).
- Indication for surgery: Failure of closed reduction or unacceptable alignment after attempted closed reduction, defined as:
- Angulation > 15° in any plane (sagittal or frontal).
- Translation > 50% of bone diameter.
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- Bayonet apposition.
- Open fracture (Gustilo type I).
- Inability to maintain acceptable reduction after cast immobilization (loss of reduction).
- Skeletal maturity: Open or partially open distal radial physis (assessed on preoperative radiographs).
Who cannot join
- Open fracture Gustilo type II \& III.
- Pathological fracture (secondary to bone cyst, tumor, osteogenesis imperfecta, etc.).
- Neurovascular compromise requiring emergent exploration (e.g., acute compartment syndrome, pulseless limb after reduction).
- Floating elbow (ipsilateral supracondylar humerus fracture + forearm fracture).
- Monteggia or Galeazzi fracture-dislocation patterns
- Metabolic bone disease (e.g., rickets, osteomalacia, renal osteodystrophy).
- Neuromuscular disorder affecting upper extremity function (e.g., cerebral palsy, muscular dystrophy, brachial plexus injury).
- Active infection at surgical site or systemic infection.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Faculty of medicine, Sohag university
Sohag
ramadan moanes, +201068323176, ramadanmoanes@gmail.com
About this study
Official title: Locking Compression Mini-plate Osteosynthesis Versus Titanium Elastic Intramedullary Nailing in Management of Diaphyseal Forearm Fractures in Adolescents
evaluate and compare the clinical, and radiographic outcomes of 2.7 mm locking compression mini-plate osteosynthesis versus titanium elastic intramedullary nail (TEN) in the surgical management of diaphyseal fractures of both forearm bones in adolescent patients
- Conditions
- Forearm Fractures
- Being tested
- Open reduction and internal fixation, Closed or mini-open reduction and fixation
- Keywords
- Diaphyseal forearm fractures in adolescents
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open reduction and internal fixationProcedure or surgery
Group A (mini-Plate group): Open reduction and internal fixation (ORIF) using a 2.7 mm locking compression mini-plate (LCP) system.
Closed or mini-open reduction and fixationProcedure or surgery
Group B (TEN group): Closed or mini-open reduction and fixation using titanium elastic nails (TENs).
| Study group | Role | What they receive |
|---|---|---|
| Group (plate) | Active comparator | Group A (mini-Plate group): Open reduction and internal fixation (ORIF) using a 2.7 mm locking compression mini-plate (LCP) system Receives: Procedure: Open reduction and internal fixation |
| Group (TENs) | Active comparator | Group B (TEN group): Closed or mini-open reduction and fixation using titanium elastic nails (TENs) Receives: Procedure: Closed or mini-open reduction and fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional outcome assessed using the Grace and Eversmann scoring system.
Measured: 6 months
Secondary outcomes (1)
Radiographic Bone Union Time
the time until bridging callus is visible across at least 3 of 4 cortices on standard AP and lateral X-rays
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2026
- Study start15 Jul 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Forearm FracturesStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ramadan Moanes Ramadan, Sohag University
- Investigators
- ramadan moanes, Principal investigator, Faculty of medicine, Sohag university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07705347
- Sponsor's protocol ID
- Soh-Med-26-6-18MS
- Status last verified
- Jul 2026
- First submitted
- 29 Jun 2026
- Last updated
- 15 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Locking Compression Mini-plate Osteosynthesis Versus Titanium Elastic Intramedullary Nailing in Management of Diaphyseal Forearm Fractures in Adolescents
- ClinicalTrials.gov ID
- NCT07705347
- Acronym / sponsor ID
- Soh-Med-26-6-18MS
- Conditions
- Forearm Fractures
- Keywords
- Diaphyseal forearm fractures in adolescents
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 15 Jul 2026 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 15 Jul 2026 (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.
evaluate and compare the clinical, and radiographic outcomes of 2.7 mm locking compression mini-plate osteosynthesis versus titanium elastic intramedullary nail (TEN) in the surgical management of diaphyseal fractures of both forearm bones in adolescent patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group (plate) | Active comparator | Procedure: Open reduction and internal fixationGroup A (mini-Plate group): Open reduction and internal fixation (ORIF) using a 2.7 mm locking compression mini-plate (LCP) system |
| Group (TENs) | Active comparator | Procedure: Closed or mini-open reduction and fixationGroup B (TEN group): Closed or mini-open reduction and fixation using titanium elastic nails (TENs) |
Who may qualify
- Ages
- 10 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Age: 10 to 16 years (at time of injury).
- Fracture pattern: diaphyseal fracture involving both the radius or ulna.
- o Fracture location: Diaphysis defined as the segment between the proximal metaphyseal flare (distal to bicipital tuberosity for radius; distal to coronoid process for ulna) and the distal metaphyseal flare (within 3 cm of the distal physis).
- Indication for surgery: Failure of closed reduction or unacceptable alignment after attempted closed reduction, defined as:
- Skeletal maturity: Open or partially open distal radial physis (assessed on preoperative radiographs).
Key exclusion criteria (8 listed)
- Open fracture Gustilo type II \& III.
- Pathological fracture (secondary to bone cyst, tumor, osteogenesis imperfecta, etc.).
- Neurovascular compromise requiring emergent exploration (e.g., acute compartment syndrome, pulseless limb after reduction).
- Floating elbow (ipsilateral supracondylar humerus fracture + forearm fracture).
- Monteggia or Galeazzi fracture-dislocation patterns
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 |
|---|---|---|
| Open reduction and internal fixationGroup A (mini-Plate group): Open reduction and internal fixation (ORIF) using a 2.7 mm locking compression mini-plate (LCP) system. | Procedure or surgery | Group (plate) |
| Closed or mini-open reduction and fixationGroup B (TEN group): Closed or mini-open reduction and fixation using titanium elastic nails (TENs). | Procedure or surgery | Group (TENs) |
Primary outcome
Functional outcome assessed using the Grace and Eversmann scoring system.
Time frame: 6 months
1 secondary outcome
Radiographic Bone Union Time
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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.
ramadan moanes principal investigator
Faculty of medicine, Sohag university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Open reduction and internal fixation and Closed or mini-open reduction and fixation in people with Forearm 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 10 inclusion and 8 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: opening soon, as of the sponsor's last update on 15 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ramadan Moanes (+201068323176, ramadanmoanes@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional outcome assessed using the Grace and Eversmann scoring system. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jul 2026.