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Fracture, RadiusNCT06459557

Management of Pediatric Distal Radius Fractures : Conservative Treatment Versus Surgical Reduction

A study testing cast and surgical reduction in people with Fracture, Radius, run by Assiut University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

To compare functional and radiological assessment between two groups of children with displaced distal radius fractures : those who will receive surgical reduction and those who will not. Read more about this study

Who is it for?
Ages 3 to 10 years
Conditions the study is for
Fracture, Radius
What is being tested?
cast and surgical reduction
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
No sites listed yet
Study dates
1 Jul 2024to 1 Apr 2026
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 3 to 10 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • All children aged 3 to 10 years
  • both genders
  • patients presenting with displaced distal radius fractures

Who cannot join

  • intra articular fractures
  • Greenstick and buckle fractures
  • fractures with more than 1 week duration
  • non displaced fractures
  • Salter Harris fractures
  • open fractures
Show all 10Show fewer
  • fractures with neurovascular bundle injury
  • poly trauma patients
  • patients with pathological bone diseases as Osteogenesis Imperfecta or CP (cerebral palsy) .
  • Galeazzi fractures

Trial locations and contacts

No sites are listed yet.

Omar Hasan, resident contact

01145422265

Omar.15235482@med.aun.edu.eg

About this study

Official title: Management of Pediatric Distal Radius Fractures : Conservative Treatment Versus Surgical Reduction - a Randomized Controlled Trial

To compare functional and radiological assessment between two groups of children with displaced distal radius fractures : those who will receive surgical reduction and those who will not.

Read the detailed description

Distal radius fractures are the most frequent fractures seen in pediatric population accounting for about 20-30% of all fractures in children , for the non-displaced pediatric distal radius fractures , it is agreed widely to be just managed by an immobilization cast in the emergency department . However when it comes to the displaced fractures , Different centers have different options of management , mostly including either the surgical anatomical reduction under general anesthesia then casting with or without using other fixation method which is mostly k-wires , or the other option includes only casting in the emergency department without trial of reduction or just a trial of realignment under sedating agent , this second option depends on the unique phenomenon of remodeling in the pediatric fractures , as Unlike adults, in growing children, remodeling can restore the alignment of the displaced fractures to a certain extent, making anatomical reduction less essential , specially when it comes to distal radius as The distal radial and ulnar physes are responsible for about 80% of forearm length and for 40% of upper limb length that making their remodeling potential can approach upto 100% . depending on that the question was that if the fracture will be fully remodeled with no functional or range of motion disturbance on the conservative option so what the essentiality of the surgical option can be . along with exposing the child to the dangers of general anesthesia , the minor complications that can occur with k wires (as neuropraxia , pin tract infection or migration of the k wire) , emotional and financial load . in a cost analysis for different options of treatment in displaced pediatric distal radius fractures , the cost of surgical option exceeds the conservative one by multiple times . According to that a lot of the current literature have suggested to consider conservative treatment of pediatric displaced distal radius fractures to be the gold standard and fundamental option of treatment . In this study the investigators question the effectiveness of conservative treatment to displaced pediatric distal radius fractures (casting in the emergency department) in comparison to the surgical anatomical reduction in matters of functional and radiological parameters .

Being tested
cast, surgical reduction
Medical subject headings
Radius Fractures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • castProcedure or surgery

    children with displaced distal radius fractures would be managed by a cast in the emergency room

  • surgical reductionProcedure or surgery

    anatomical reduction of pediatric displaced distal radius fractures under general anesthesia in the operating room

Study groups in NCT06459557
Study groupRoleWhat they receive
conservative treatment of displaced pediatric distal radius fracturesActive comparatorchildren in this group with displaced distal radius fractures would be managed by a cast in the emergency room without anatomically reducing the fracture under general anesthesia in the operating room
Receives: Procedure: cast
surgical reduction of displaced distal radius fracturesActive comparatorchildren in this group with displaced distal radius fractures would be managed by being anatomically reducing the fracture in the operating room under general anesthesia
Receives: Procedure: surgical reduction

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. mean difference of Modifed the Disabilities of the Arm, Shoulder and Hand (m-DASH) score between the two groups

    functional assessment at 1.5 , 3 , 6 and 12 months posttrauma using the Modifed the Disabilities of the Arm, Shoulder and Hand (m-DASH) score as (50/50) (100%) is considered the maximum value which is the best outcome and (10/50) (0%) is considered the minimum value which is the worst outcome

    Measured: 12 months

Secondary outcomes (3)

  1. Comparing palmar tilt angle between the 2 groups .

    radiological assessment poattraumatic at 1.5 , 3 , 6 ,12 months for lateral view of wrist joint for the 2 groups comparing palmar tilt angle which is the angle formed by a line drawn perpendicular to the axis of the radial shaft, and a line that passes through the tips of the dorsal and volar rims (i.e. along the radius articular surface)

    Measured: 12 months

  2. Comparing radial inclination between the 2 groups

    radiological assessment posttraumatic at 1.5 , 3 , 6 ,12 months for anterioposterior view of wrist joint for the 2 groups comparing radial inclination which is the angle between a line drawn perpendicular to the long axis of the radius along the articular surface of the distal radius and a line drawn down from the tip of the radial styloid

    Measured: 12 months

  3. Comparing radius length between the 2 groups

    radiological assessment posttraumatic at 1.5 , 3 , 6 ,12 months for anterioposterior view of wrist joint for the 2 groups comparing radius length which is the distance between two lines drawn perpendicular to the long axis of the radius on the AP projection from the apex of the radial styloid and level of the ulnar aspect of the articular surface

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jun 2024
  2. Study start1 Jul 2024 (estimated)
  3. Primary completion1 Feb 2026 (estimated)
  4. Study completion1 Apr 2026 (estimated)

Resources

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
52 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06459557
Sponsor's protocol ID
casting of distal radius
Status last verified
Jun 2024
First submitted
12 May 2024
Last updated
14 Jun 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Akar D, Koroglu C, Erkus S, Turgut A, Kalenderer O. Conservative Follow-up of Severely Displaced Distal Radial Metaphyseal Fractures in Children. Cureus. 2018 Sep 5;10(9):e3259. doi: 10.7759/cureus.3259.

    PubMed 30430048

  • Shah AS, Guzek RH, Miller ML, Willey MC, Mahan ST, Bae DS; Pediatric Distal Radius Fracture (PDRF) Study Group. Descriptive Epidemiology of Isolated Distal Radius Fractures in Children: Results From a Prospective Multicenter Registry. J Pediatr Orthop. 2023 Jan 1;43(1):e1-e8. doi: 10.1097/BPO.0000000000002288. Epub 2022 Oct 26.

    PubMed 36299238

  • Hove LM, Brudvik C. Displaced paediatric fractures of the distal radius. Arch Orthop Trauma Surg. 2008 Jan;128(1):55-60. doi: 10.1007/s00402-007-0473-x. Epub 2007 Oct 17.

    PubMed 17940779

  • Sengab A, Krijnen P, Schipper IB. Displaced distal radius fractures in children, cast alone vs additional K-wire fixation: a meta-analysis. Eur J Trauma Emerg Surg. 2019 Dec;45(6):1003-1011. doi: 10.1007/s00068-018-1011-y. Epub 2018 Oct 1.

    PubMed 30276723

  • Marinelli M, Massetti D, Facco G, Falcioni D, Coppa V, Maestri V, Gigante A. Remodeling of distal radius fractures in children: preliminary retrospective cost/analysis in level II pediatric trauma center. Acta Biomed. 2021 Nov 3;92(5):e2021390. doi: 10.23750/abm.v92i5.11971.

    PubMed 34738560

  • Naik P. Remodelling in Children's Fractures and Limits of Acceptability. Indian J Orthop. 2021 Mar 10;55(3):549-559. doi: 10.1007/s43465-020-00320-2. eCollection 2021 Jun.

    PubMed 33995859

  • Orland KJ, Boissonneault A, Schwartz AM, Goel R, Bruce RW Jr, Fletcher ND. Resource Utilization for Patients With Distal Radius Fractures in a Pediatric Emergency Department. JAMA Netw Open. 2020 Feb 5;3(2):e1921202. doi: 10.1001/jamanetworkopen.2019.21202.

    PubMed 32058553

  • Colovic H, Stankovic I, Dimitrijevic L, Zivkovic V, Nikolic D. The value of modified DASH questionnaire for evaluation of elbow function after supracondylar fractures in children. Vojnosanit Pregl. 2008 Jan;65(1):27-32. doi: 10.2298/vsp0801027c.

    PubMed 18368935

Questions about this trial

What is this clinical trial studying?

A study testing cast and surgical reduction in people with Fracture, Radius, run by Assiut University.

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 10 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 14 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

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 Omar Hasan, resident (01145422265, Omar.15235482@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

mean difference of Modifed the Disabilities of the Arm, Shoulder and Hand (m-DASH) score between the two groups (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 NCT06459557, which also lists 8 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 14 Jun 2024.

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