Fracture Fixation, IntramedullaryNCT05744349
Percutaneous Intramedullary K-wires Fixation of Pediatric Shaft Both Bone Forearm Fractures
A study testing K-wires Fixation of Pediatric Shaft Both Bone Forearm Fractures in people with Fracture Fixation, Intramedullary and Fracture Forearm, run by Sohag University at 1 site in Egypt.
Trial summary
This study is to improving outcome of pediatric both bone forearm fractures using minimally invasive procedure by intramedullary K-wires. Read more about this study
- Who is it for?
- Ages 4 to 10 years
- Conditions the study is for
- Fracture Fixation, Intramedullary, Fracture Forearm
- What is being tested?
- K-wires Fixation of Pediatric Shaft Both Bone Forearm Fractures
- 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
- 28 Feb 2023to 1 Apr 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 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients who are younger than the age of 10 years old from both genders and suffering from displaced fractures of shaft both bone of the forearm;
- Standard preoperative anteroposterior (AP) and lateral forearm radiographs;
- Complete clinical and radiographic data.
Who cannot join
- Poly-traumatized patients with other associated fractures;
- Undisplaced fractures;
- Open fractures;
- Pathological fractures;
- Malignancy;
- Malnutrition;
- Chronic diseases as renal, hepatic, cardiac patients;
- Incomplete radiographic data.
Trial locations and contacts
1 site in 1 country.
Ahmad I Addosooki, Professor contact
About this study
This study is to improving outcome of pediatric both bone forearm fractures using minimally invasive procedure by intramedullary K-wires.
Read the detailed description
Most shaft injuries present no unusual challenges and require nothing more than skillful closed reduction and cast immobilization due to the unique property of the growth potential of the immature skeleton. There is a relatively high incidence of re-displacement, malunion and consequent limitation of movement. Perfect anatomical reduction is not always necessary since remodeling of malunion may correct any residual deformity. Angulation has been shown to affect the range of pronation and supination of the forearm.
The most common indications for surgery are failure of closed reduction, open fractures, and fracture instability. When operative intervention is indicated different techniques can be employed such as intramedullary nailing, osteosynthesis with plate and screws fixation and external fixators. Intramedullary nailing has been shown to produce excellent clinical results and in contrast to plate fixation is considered as a minimal invasive procedure.
Surgical technique of K-wires :
After administration of anesthesia, surgery will be performed with the patient supine on the operating table and fracture will be analyzed with an image intensifier. In radius, the wire will be inserted by surgical drilling through Lister's tubercle or the radial styloid while in ulna, the wire will be inserted through the tip of the olecranon.
- Being tested
- K-wires Fixation of Pediatric Shaft Both Bone Forearm Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
K-wires Fixation of Pediatric Shaft Both Bone Forearm FracturesProcedure or surgery
After administration of anesthesia, surgery will be performed with the patient supine on the operating table and fracture will be analyzed with an image intensifier. In radius, the wire will be inserted by surgical drilling through Lister's tubercle or the radial styloid while in ulna, the wire will be inserted through the tip of the olecranon.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Patients who are younger than the age of 10 years old from both genders and suffering from displaced fractures of shaft both bone of the forearm Receives: Procedure: K-wires Fixation of Pediatric Shaft Both Bone Forearm Fractures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Union of fractures
Measured: 1 month
Degree of flexion and extension at wrist joint
Measured: 3 months
Degree of supination and pronation
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2023
- Study start28 Feb 2023
- Primary completion28 Feb 2024 (estimated)
- Study completion1 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Fracture Fixation, IntramedullaryStudies 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
- Model description
- After administration of anesthesia, surgery will be performed with the patient supine on the operating table and fracture will be analyzed with an image intensifier. In radius, the wire will be inserted by surgical drilling through Lister's tubercle or the radial styloid while in ulna, the wire will be inserted through the tip of the olecranon.
- 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, Mahmoud Hamdy Abdelmajeed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05744349
- Sponsor's protocol ID
- Soh-Med-23-02-01
- Status last verified
- Apr 2023
- First submitted
- 15 Feb 2023
- Last updated
- 18 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Yong B, Yuan Z, Li J, Li Y, Southern EP, Canavese F, Xu H. Single Bone Fixation versus Both Bone Fixation for Pediatric Unstable Forearm Fractures: A Systematic Review and Metaanalysis. Indian J Orthop. 2018 Sep-Oct;52(5):529-535. doi: 10.4103/ortho.IJOrtho_125_17.
PubMed 30237611Cruz AI Jr, DeFroda SF, Gil JA, Hansen H, Bolous A, Procaccini M, Zonfrillo MR. Patient and Parent Satisfaction With Sling Use After Pediatric Upper Extremity Fractures: A Randomized Controlled Trial of a Customized Cast-Sling Versus Standard Cast and Sling. J Pediatr Orthop. 2019 Feb;39(2):e120-e124. doi: 10.1097/BPO.0000000000001091.
PubMed 29049268Pesenti S, Litzelmann E, Kahil M, Mallet C, Jehanno P, Mercier JC, Ilharreborde B, Mazda K. Feasibility of a reduction protocol in the emergency department for diaphyseal forearm fractures in children. Orthop Traumatol Surg Res. 2015 Sep;101(5):597-600. doi: 10.1016/j.otsr.2015.06.003. Epub 2015 Jul 18.
PubMed 26198018Sinikumpu JJ, Lautamo A, Pokka T, Serlo W. The increasing incidence of paediatric diaphyseal both-bone forearm fractures and their internal fixation during the last decade. Injury. 2012 Mar;43(3):362-6. doi: 10.1016/j.injury.2011.11.006. Epub 2011 Dec 6.
PubMed 22154046
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Intramedullary K-wires Fixation of Pediatric Shaft Both Bone Forearm Fractures
- ClinicalTrials.gov ID
- NCT05744349
- Acronym / sponsor ID
- Soh-Med-23-02-01
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 28 Feb 2023 (actual)
- Primary completion
- 28 Feb 2024 (estimated)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 27 Feb 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.
This study is to improving outcome of pediatric both bone forearm fractures using minimally invasive procedure by intramedullary K-wires.
Detailed description
Most shaft injuries present no unusual challenges and require nothing more than skillful closed reduction and cast immobilization due to the unique property of the growth potential of the immature skeleton. There is a relatively high incidence of re-displacement, malunion and consequent limitation of movement. Perfect anatomical reduction is not always necessary since remodeling of malunion may correct any residual deformity. Angulation has been shown to affect the range of pronation and supination of the forearm.
The most common indications for surgery are failure of closed reduction, open fractures, and fracture instability. When operative intervention is indicated different techniques can be employed such as intramedullary nailing, osteosynthesis with plate and screws fixation and external fixators. Intramedullary nailing has been shown to produce excellent clinical results and in contrast to plate fixation is considered as a minimal invasive procedure.
Surgical technique of K-wires :
After administration of anesthesia, surgery will be performed with the patient supine on the operating table and fracture will be analyzed with an image intensifier. In radius, the wire will be inserted by surgical drilling through Lister's tubercle or the radial styloid while in ulna, the wire will be inserted through the tip of the olecranon.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- After administration of anesthesia, surgery will be performed with the patient supine on the operating table and fracture will be analyzed with an image intensifier. In radius, the wire will be inserted by surgical drilling through Lister's tubercle or the radial styloid while in ulna, the wire will be inserted through the tip of the olecranon.
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Procedure: K-wires Fixation of Pediatric Shaft Both Bone Forearm FracturesPatients who are younger than the age of 10 years old from both genders and suffering from displaced fractures of shaft both bone of the forearm |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Patients who are younger than the age of 10 years old from both genders and suffering from displaced fractures of shaft both bone of the forearm;
- Standard preoperative anteroposterior (AP) and lateral forearm radiographs;
- Complete clinical and radiographic data.
Key exclusion criteria (8 listed)
- Poly-traumatized patients with other associated fractures;
- Undisplaced fractures;
- Open fractures;
- Pathological fractures;
- Malignancy;
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 |
|---|---|---|
| K-wires Fixation of Pediatric Shaft Both Bone Forearm FracturesAfter administration of anesthesia, surgery will be performed with the patient supine on the operating table and fracture will be analyzed with an image intensifier. In radius, the wire will be inserted by surgical drilling through Lister's tubercle or the radial styloid while in ulna, the wire will be inserted through the tip of the olecranon. | Procedure or surgery | Study group |
Primary outcome
Union of fractures
Time frame: 1 month
Degree of flexion and extension at wrist joint
Time frame: 3 months
Degree of supination and pronation
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Background: PubMed 30237611Yong B, Yuan Z, Li J, Li Y, Southern EP, Canavese F, Xu H. Single Bone Fixation versus Both Bone Fixation for Pediatric Unstable Forearm Fractures: A Systematic Review and Metaanalysis. Indian J Orthop. 2018 Sep-Oct;52(5):529-535. doi: 10.4103/ortho.IJOrtho_125_17.
- Background: PubMed 29049268Cruz AI Jr, DeFroda SF, Gil JA, Hansen H, Bolous A, Procaccini M, Zonfrillo MR. Patient and Parent Satisfaction With Sling Use After Pediatric Upper Extremity Fractures: A Randomized Controlled Trial of a Customized Cast-Sling Versus Standard Cast and Sling. J Pediatr Orthop. 2019 Feb;39(2):e120-e124. doi: 10.1097/BPO.0000000000001091.
- Background: PubMed 26198018Pesenti S, Litzelmann E, Kahil M, Mallet C, Jehanno P, Mercier JC, Ilharreborde B, Mazda K. Feasibility of a reduction protocol in the emergency department for diaphyseal forearm fractures in children. Orthop Traumatol Surg Res. 2015 Sep;101(5):597-600. doi: 10.1016/j.otsr.2015.06.003. Epub 2015 Jul 18.
- Background: PubMed 22154046Sinikumpu JJ, Lautamo A, Pokka T, Serlo W. The increasing incidence of paediatric diaphyseal both-bone forearm fractures and their internal fixation during the last decade. Injury. 2012 Mar;43(3):362-6. doi: 10.1016/j.injury.2011.11.006. Epub 2011 Dec 6.
- 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. This study is not recruiting at the moment.
Ahmad I Addosooki, Professor 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 K-wires Fixation of Pediatric Shaft Both Bone Forearm Fractures in people with Fracture Fixation, Intramedullary and Fracture Forearm, 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 3 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: status not confirmed, as of the sponsor's last update on 18 Apr 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 Mahmoud H Abdelmajeed, Resident (01201605995, Mahmood-h-2010@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Union of fractures (time frame: 1 month). The study lists 3 primary outcomes in all. 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 NCT05744349, which also lists 4 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 18 Apr 2023.