Trauma Injury of Upper Extremity Forearm MultipleNCT06276062
Uses of Titanium Nail in Pediatric Fractures
A study testing Distal radius fracture fixation in pediatrics. in people with Trauma Injury of Upper Extremity Forearm Multiple and Fracture of Distal End of Radius, run by Sohag University at 1 site in Egypt.
Trial summary
The aim of this study is to investigate the short term functional and radiological outcomes of using double short titanium elastic nails as treatment of pediatric distal radius fractures. Read more about this study
- Who is it for?
- Ages 4 to 16 years
- Conditions the study is for
- Trauma Injury of Upper Extremity Forearm Multiple, Fracture of Distal End of Radius
- What is being tested?
- Distal radius fracture fixation in pediatrics.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2023to Oct 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 4 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patient Age ( 4 - 16 ) Years old.
- Both sex included .
- Simple or compound fractures (Grade I).
- Isolated fracture in the limb.
- Severely displaced fracture (Angulated).
- Recent and old distal radius fractures
Who cannot join
- Ages below 4 years or above 16 years.
- Associated with other fractures in the same limb.
- Compound fractures ( Grade II,III).
- Comminuted or Pathological fractures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Short Term Functional and Radiological Outcomes of Using Double Short Titanium Elastic Nails in Treatment of Pediatric Distal Radius Fractures.
The aim of this study is to investigate the short term functional and radiological outcomes of using double short titanium elastic nails as treatment of pediatric distal radius fractures.
Read the detailed description
Severely displaced distal radial fractures in children are generally considered unstable; especially when associated with total rupture of the periosteum. Although the remodeling potential of distal radial fractures is very good in childhood, a subgroup of severely displaced and unstable distal pediatric forearm fractures are candidates for operative fixation because acceptable reduction cannot be maintained in a conservative way. These injuries are usually candidates for closed reduction and minimal invasive fixation.
Operative osteosynthesis technique of pediatric wrist fractures are optimally minimally invasive, physeal sparing, and with acceptable reduction.
Most operative methods need complementary 4 to 6 weeks of postoperative immobilization by casting. Many of these techniques do not respect physeal plates. Both current available fixation techniques; modifications of Kirschner wiring or conventional elastic stable intramedullary nailing [ESIN]) have the same rate of mild complications. Growth disturbance is a rare, but represents a very rare severe complication of transepiphyseal wire placement.
Varga et al. Medicine (2017) 96:14[8] used modified ESIN method for operative treatment of severely displaced pediatric distal metaphyseal or metadiaphyseal radial fractures. With 2 short, prebent, retrograde elastic titanium nails inserted proximal to the distal radial physis, a very stable stabilization achieved without the need for a prolonged period of cast immobilization. The nails do not cross the physeal plates, so the possibility of postoperative physeal arrest is reduced.
their results:(the study shows a new technique in fixation of severely displaced pediatric distal radial fractures é more stable fixation,less pin track irritations and infections,early return to full range of motion within the sixth postoperative week, short removable splint was sufficient for early pain-free mobilization.
All the x-rays made 6 months postoperatively showed anatomic reduction, and there has been no sign of omic reduction, and there has been no sign of growth disturbance at the area of thece at the area of the distal radius) We conduct this study to evaluate the Short term functional and radiological outcomes of using double short titanium elastic nails in treatment of pediatric distal radius fractures.
- Being tested
- Distal radius fracture fixation in pediatrics.
- Keywords
- Pediatric Trauma, fractures, Double Titanium nail, Distal Radial Fractures, Intramedullary nail fixation
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Distal radius fracture fixation in pediatrics.Procedure or surgery
using double short titanium elastic nails in treatment of pediatric distal radius fractures.
| Study group | Role | What they receive |
|---|---|---|
| pediatric distal radial fractures. | Experimental | Pediatric traumatized patients aged between 4 to 16 years old who presented by distal radial fractures and need to go under operative management. Receives: Procedure: Distal radius fracture fixation in pediatrics. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison between usage of titanium nail and old methods
As old techniques used to reduce severely displaced fracture, the new technique assures better healing and full range motion.
Measured: 2 Weeks up to 6 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2024
- Study start1 Sep 2023
- Primary completionSep 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Trauma Injury of Upper Extremity Forearm MultipleStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Abdellah Desoky, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06276062
- Sponsor's protocol ID
- Titanium nail usage
- Status last verified
- Feb 2024
- First submitted
- 18 Feb 2024
- Last updated
- 28 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Varga M, Jozsa G, Fadgyas B, Kassai T, Renner A. Short, double elastic nailing of severely displaced distal pediatric radial fractures: A new method for stable fixation. Medicine (Baltimore). 2017 Apr;96(14):e6532. doi: 10.1097/MD.0000000000006532.
PubMed 28383417
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Term Functional and Radiological Outcomes of Using Double Short Titanium Elastic Nails in Treatment of Pediatric Distal Radius Fractures.
- ClinicalTrials.gov ID
- NCT06276062
- Acronym / sponsor ID
- Titanium nail usage
- Keywords
- Pediatric Trauma, fractures, Double Titanium nail, Distal Radial Fractures, Intramedullary nail fixation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 23 Feb 2024 (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.
The aim of this study is to investigate the short term functional and radiological outcomes of using double short titanium elastic nails as treatment of pediatric distal radius fractures.
Detailed description
Severely displaced distal radial fractures in children are generally considered unstable; especially when associated with total rupture of the periosteum. Although the remodeling potential of distal radial fractures is very good in childhood, a subgroup of severely displaced and unstable distal pediatric forearm fractures are candidates for operative fixation because acceptable reduction cannot be maintained in a conservative way. These injuries are usually candidates for closed reduction and minimal invasive fixation.
Operative osteosynthesis technique of pediatric wrist fractures are optimally minimally invasive, physeal sparing, and with acceptable reduction.
Most operative methods need complementary 4 to 6 weeks of postoperative immobilization by casting. Many of these techniques do not respect physeal plates. Both current available fixation techniques; modifications of Kirschner wiring or conventional elastic stable intramedullary nailing [ESIN]) have the same rate of mild complications. Growth disturbance is a rare, but represents a very rare severe complication of transepiphyseal wire placement.
Varga et al. Medicine (2017) 96:14[8] used modified ESIN method for operative treatment of severely displaced pediatric distal metaphyseal or metadiaphyseal radial fractures. With 2 short, prebent, retrograde elastic titanium nails inserted proximal to the distal radial physis, a very stable stabilization achieved without the need for a prolonged period of cast immobilization. The nails do not cross the physeal plates, so the possibility of postoperative physeal arrest is reduced.
their results:(the study shows a new technique in fixation of severely displaced pediatric distal radial fractures é more stable fixation,less pin track irritations and infections,early return to full range of motion within the sixth postoperative week, short removable splint was sufficient for early pain-free mobilization.
All the x-rays made 6 months postoperatively showed anatomic reduction, and there has been no sign of omic reduction, and there has been no sign of growth disturbance at the area of thece at the area of the distal radius) We conduct this study to evaluate the Short term functional and radiological outcomes of using double short titanium elastic nails in treatment of pediatric distal radius fractures.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pediatric distal radial fractures. | Experimental | Procedure: Distal radius fracture fixation in pediatrics.Pediatric traumatized patients aged between 4 to 16 years old who presented by distal radial fractures and need to go under operative management. |
Who may qualify
- Ages
- 4 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Patient Age ( 4 - 16 ) Years old.
- Both sex included .
- Simple or compound fractures (Grade I).
- Isolated fracture in the limb.
- Severely displaced fracture (Angulated).
Key exclusion criteria (4 listed)
- Ages below 4 years or above 16 years.
- Associated with other fractures in the same limb.
- Compound fractures ( Grade II,III).
- Comminuted or Pathological fractures.
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 |
|---|---|---|
| Distal radius fracture fixation in pediatrics.using double short titanium elastic nails in treatment of pediatric distal radius fractures. | Procedure or surgery | pediatric distal radial fractures. |
Primary outcome
Comparison between usage of titanium nail and old methods
Time frame: 2 Weeks up to 6 Weeks
As old techniques used to reduce severely displaced fracture, the new technique assures better healing and full range motion.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Background: PubMed 28383417Varga M, Jozsa G, Fadgyas B, Kassai T, Renner A. Short, double elastic nailing of severely displaced distal pediatric radial fractures: A new method for stable fixation. Medicine (Baltimore). 2017 Apr;96(14):e6532. doi: 10.1097/MD.0000000000006532.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Distal radius fracture fixation in pediatrics. in people with Trauma Injury of Upper Extremity Forearm Multiple and Fracture of Distal End of Radius, 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 6 inclusion and 4 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.
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 Mostafa Abdellah Desoky, MD (+201126002826, mostafaabdelaah@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison between usage of titanium nail and old methods (time frame: 2 Weeks up to 6 Weeks). 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 NCT06276062, which also lists 1 linked publication.
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.