Forearm FractureNCT03906929
Exposed Versus Buried Intramedullary K-wires for Pediatric Forearm Fractures
A study testing buried intramedullary K-wire and exposed intramedullary K-wire in people with Forearm Fracture, run by Assiut University at 1 site in Egypt.
Trial summary
Comparing the rate of complications between buried and exposed intramedullary implants after fixation of pediatric forearm fractures. Read more about this study
- Who is it for?
- Ages 5 to 10 years
- Conditions the study is for
- Forearm Fracture
- What is being tested?
- buried intramedullary K-wire and exposed intramedullary K-wire
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2019to 1 Oct 2020
- 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 5 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age: less than 10 years .
- Diaphyseal forearm fracture.
- closed fracture.
- isolated or combined fracture of forearm.
Who cannot join
- 1. Patient age: more than 10 years old . 2-open fracture. 3- pathological fracture. 4-patient with medical history (immune compromized patient e.g D.M, cancer on chemotherapy and aplastic anemia).
- 5- neurovascular injury.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exposed Versus Buried Intramedullary K-wires for Pediatric Forearm Fractures: a Randomized Controlled Trial.
Comparing the rate of complications between buried and exposed intramedullary implants after fixation of pediatric forearm fractures.
Read the detailed description
comparison between buried and exposed intramedullary k-wire in fixation of pediatric forearm fracture in rate of complications such as infection,malunion,nonunion and refracture.
- Conditions
- Forearm Fracture
- Being tested
- buried intramedullary K-wire, exposed intramedullary K-wire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
buried intramedullary K-wireDevice
Also called buried intramedullary kirschner wire
Using of buried kirschner wire in pediatric forearm fixation
exposed intramedullary K-wireDevice
Also called exposed intramedullary kirschner wire
Using of exposed kirschner wire in pediatric forearm fixation
| Study group | Role | What they receive |
|---|---|---|
| Pediatric forearm fracture fixed by buried or exposed intamedullary implant | Experimental | compare complication of buried or exposed intamedullary implant Receives: Device: buried intramedullary K-wire; Device: exposed intramedullary K-wire |
What is being measured
The primary outcome is the main question the study is designed to answer.
compare the rate of refracture in participants who fixed by buried and exposed K-wire.
comparison between the rate of refractures in participants who fixed by buried and exposed K-wire by follow up every month for six month.
Measured: 6 months
Secondary outcomes (1)
compare the rate of infection and malunion in participants who fixed by buried and exposed K-wire.
compare the rate of infection and malunion in participants who fixed by buried and exposed K-wire.
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 posted8 Apr 2019
- Study start1 Sep 2019
- Primary completion1 Sep 2020
- Study completion1 Oct 2020
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 Forearm FractureStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Using of buried and exposed intramedullary k-wire in pediatric forearm fixation.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew Nabil Fouad Gergis, Assiut University
- Investigators
- Mohamed K Hassan, professor, Principal investigator, professor of orthopedic and traumatology Assuit university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03906929
- Sponsor's protocol ID
- fixation of forearm fracture
- Status last verified
- Aug 2022
- First submitted
- 3 Apr 2019
- Last updated
- 9 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chan LW, Siow HM. Exposed versus buried wires for fixation of lateral humeral condyle fractures in children: a comparison of safety and efficacy. J Child Orthop. 2011 Oct;5(5):329-33. doi: 10.1007/s11832-011-0358-y. Epub 2011 Jul 28.
PubMed 23024723Tsukamoto N, Mae T, Yamashita A, Hamada T, Miura T, Iguchi T, Tokunaga M, Onizuka T, Momii K, Sadashima E, Nakashima Y. Refracture of pediatric both-bone diaphyseal forearm fracture following intramedullary fixation with Kirschner wires is likely to occur in the presence of immature radiographic healing. Eur J Orthop Surg Traumatol. 2020 Oct;30(7):1231-1241. doi: 10.1007/s00590-020-02689-0. Epub 2020 May 5.
PubMed 32372119Lascombes P, Haumont T, Journeau P. Use and abuse of flexible intramedullary nailing in children and adolescents. J Pediatr Orthop. 2006 Nov-Dec;26(6):827-34. doi: 10.1097/01.bpo.0000235397.64783.d6.
PubMed 17065959Khaled M, Fadle AA, Hassan AAA, Khalifa AA, Nabil A, Hafez A, Abol Oyoun N. To Bury or Not to Bury the K-wires After Fixation of Both Bone Forearm Fractures in Patients Younger Than 11 Years Old: A Randomized Controlled Trial. J Pediatr Orthop. 2023 Nov-Dec 01;43(10):e783-e789. doi: 10.1097/BPO.0000000000002516. Epub 2023 Sep 7.
PubMed 37678342
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exposed Versus Buried Intramedullary K-wires for Pediatric Forearm Fractures: a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT03906929
- Acronym / sponsor ID
- fixation of forearm fracture
- Conditions
- Forearm Fracture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 8 Apr 2019 (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.
Comparing the rate of complications between buried and exposed intramedullary implants after fixation of pediatric forearm fractures.
Detailed description
comparison between buried and exposed intramedullary k-wire in fixation of pediatric forearm fracture in rate of complications such as infection,malunion,nonunion and refracture.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Using of buried and exposed intramedullary k-wire in pediatric forearm fixation.
| Arm | Type | Receives |
|---|---|---|
| Pediatric forearm fracture fixed by buried or exposed intamedullary implant | Experimental | Device: buried intramedullary K-wire, Device: exposed intramedullary K-wirecompare complication of buried or exposed intamedullary implant |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age: less than 10 years .
- Diaphyseal forearm fracture.
- closed fracture.
- isolated or combined fracture of forearm.
Key exclusion criteria (2 listed)
- 1. Patient age: more than 10 years old . 2-open fracture. 3- pathological fracture. 4-patient with medical history (immune compromized patient e.g D.M, cancer on chemotherapy and aplastic anemia).
- 5- neurovascular injury.
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 |
|---|---|---|
| buried intramedullary K-wireAlso: buried intramedullary kirschner wireUsing of buried kirschner wire in pediatric forearm fixation | Device | Pediatric forearm fracture fixed by buried or exposed intamedullary implant |
| exposed intramedullary K-wireAlso: exposed intramedullary kirschner wireUsing of exposed kirschner wire in pediatric forearm fixation | Device | Pediatric forearm fracture fixed by buried or exposed intamedullary implant |
Primary outcome
compare the rate of refracture in participants who fixed by buried and exposed K-wire.
Time frame: 6 months
comparison between the rate of refractures in participants who fixed by buried and exposed K-wire by follow up every month for six month.
1 secondary outcome
compare the rate of infection and malunion in participants who fixed by buried and exposed K-wire.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2022.
- Background: PubMed 23024723Chan LW, Siow HM. Exposed versus buried wires for fixation of lateral humeral condyle fractures in children: a comparison of safety and efficacy. J Child Orthop. 2011 Oct;5(5):329-33. doi: 10.1007/s11832-011-0358-y. Epub 2011 Jul 28.
- Background: PubMed 32372119Tsukamoto N, Mae T, Yamashita A, Hamada T, Miura T, Iguchi T, Tokunaga M, Onizuka T, Momii K, Sadashima E, Nakashima Y. Refracture of pediatric both-bone diaphyseal forearm fracture following intramedullary fixation with Kirschner wires is likely to occur in the presence of immature radiographic healing. Eur J Orthop Surg Traumatol. 2020 Oct;30(7):1231-1241. doi: 10.1007/s00590-020-02689-0. Epub 2020 May 5.
- Background: PubMed 17065959Lascombes P, Haumont T, Journeau P. Use and abuse of flexible intramedullary nailing in children and adolescents. J Pediatr Orthop. 2006 Nov-Dec;26(6):827-34. doi: 10.1097/01.bpo.0000235397.64783.d6.
- Derived from this study: PubMed 37678342Khaled M, Fadle AA, Hassan AAA, Khalifa AA, Nabil A, Hafez A, Abol Oyoun N. To Bury or Not to Bury the K-wires After Fixation of Both Bone Forearm Fractures in Patients Younger Than 11 Years Old: A Randomized Controlled Trial. J Pediatr Orthop. 2023 Nov-Dec 01;43(10):e783-e789. doi: 10.1097/BPO.0000000000002516. Epub 2023 Sep 7.
- Individual participant dataSharing planned: No
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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.
Mohamed K Hassan, professor principal investigator
professor of orthopedic and traumatology Assuit 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 buried intramedullary K-wire and exposed intramedullary K-wire in people with Forearm Fracture, run by Assiut 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 4 inclusion and 2 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: finished, as of the sponsor's last update on 9 Aug 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
compare the rate of refracture in participants who fixed by buried and exposed K-wire. (time frame: 6 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 NCT03906929, 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 9 Aug 2022.