Distal Forearm FractureCASTINGNCT05736068
Is Casting of Displaced Pediatric Distal Forearm Fractures Non-inferior to Reduction in General Anesthesia?
A study testing Non-surgical treatment and Surgical treatment in people with Distal Forearm Fracture and Distal Radius Fracture, run by Zealand University Hospital at 4 sites in Denmark.
Trial summary
Treatment of displaced distal forearm fractures (DFF) in children have traditionally been closed reduction and pin fixation, although they might heal and remodel without manipulation, with no functional impairment. Read more about this study
- Who is it for?
- Ages 4 to 10 years
- Conditions the study is for
- Distal Forearm Fracture, Distal Radius Fracture
- What is being tested?
- Non-surgical treatment and Surgical treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 4 sitesDenmark
- Study dates
- 7 Sep 2023to Jan 2026
- 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 4 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children 4-10 years of age with open physes
- Fractures in the distal metaphyseal radius (with or without concomitant ulna fracture), including extraarticular physeal fractures (SH I-II)
- Overriding fractures
- Angulated fractures of 20-40°
- The on-duty surgeon finds reduction under anesthesia with or without fixation indicated
Who cannot join
- Open fractures
- Nerve or vascular affection
- All intraarticular fractures including SH III-V
- Ulnar physeal fractures
- Polytrauma
- Concomitant ipsi- or contralateral upper extremity fractures (except distal ulna fracture)
Show all 9Show fewer
- Pathologic fractures
- The injury is >7 days old
- Other conditions that may affect bone healing
Trial locations and contacts
4 sites in 1 country.
Denmark4 sites
Aalborg University Hospital
Aalborg, 9000
Aarhus University Hospital
Aarhus, 8200
Zealand University Hospital
Køge, 4600
Odense University Hospital
Odense, 5000
About this study
Official title: Is Casting of Displaced Pediatric Distal Forearm Fractures Non-inferior to Reduction in General Anesthesia? A Pragmatic, Randomized, Controlled Non-inferiority Multicenter Trial
Treatment of displaced distal forearm fractures (DFF) in children have traditionally been closed reduction and pin fixation, although they might heal and remodel without manipulation, with no functional impairment. No randomized controlled trials (RCTs) have been published comparing the patient-reported functional outcome after non-surgical and surgical treatment of displaced DFF in children.
This is a multicentre RCT. The aim of the trial is to investigate the patient-reported functional outcome after non-surgical treatment of displaced distal forearm fractures (DFF) in children. We will include 44 children aged 4-10 years with a displaced DFF. They will be offered inclusion, if the on-duty orthopedic surgeon finds indication for surgical intervention. If the parents/guardians consent to participate, the children will be allocated equally to non-surgical treatment (intervention) or surgical treatment of surgeon's choice (comparator). We will follow the children during one year, where they will be seen after 4 weeks, 3, 6 and 12 months. The primary outcome is the between-group difference in 12 months Quick Disabilities Arm Shoulder and Hand (QuickDASH) score.
Read the detailed description
Pediatric distal forearm fractures (DFF) are very common and accounts for 25-30% of all fractures in children.(1,2) Up to half of all pediatric DFF are displaced to an extent where surgery has been the preferred treatment option.(3) However, surgery does come with a cost.
The most common treatment of displaced pediatric DFF has long been closed reduction with or without pin fixation (or in rare cases plate and screw fixation) under general anesthesia, followed by immobilization in a cast.(4) Pin-related complications vary from 4-23%, depending on what is reported as complications,(5-11) and up to 40% has been reported when including re-displacements.(12) The insertion of a metal wire or plate also requires subsequent procedures to remove these implants again.
Numerous small cohort studies and case series have found pin fixation advantageous in achieving anatomic reduction and avoiding re-displacement.(5-11) However, whether anatomic reduction and stabilization is important regarding the patient-reported functional outcome has not been investigated since most studies use only radiographic or objective measures (e.g. range of motion). In addition, children's bones, and in particular the metaphysis and epiphysis, have a unique ability to heal and remodel throughout the growth period until puberty.(13) Almost 20 years ago, Do et al. (14) stated that "the tremendous capacity of distal metaphyseal radius fractures to heal and remodel makes this one of the most rewarding fractures to treat non-operatively. […]". In accordance with Do et al., other studies indicate that displaced DFF fractures in prepubertal children might heal without manipulation, and that most displaced fractures will remodel within a year or two to almost anatomical position with no functional impairment.(14-17) Although most surgeons are aware that children's bones have this remodeling potential, they still find it challenging to deal with the uncertainty of whether the bone will actually remodel to an acceptable position. Furthermore, surgeons might have difficulties with how families will react to the waiting time until the misaligned arm looks normal again.
If non-surgical treatment of displaced pediatric DFF were more common, the costs associated with surgery could be minimized. Unfortunately, there is limited evidence to guide the decision to operate or not. The available studies are typically small, retrospective cohort studies or case series of low quality with no predefined follow-up or outcome measures. To our knowledge, there are no published randomized controlled trials (RCTs) comparing non-surgical treatment with surgical treatment, and no studies report outcomes from the patient's perspective.
The aim of this trial is to investigate the patient-reported functional outcome after non-surgical treatment of displaced DFF in children aged 4-10 years. Our hypothesis is, that casting without manipulation is non-inferior to surgical treatment.
- Conditions
- Distal Forearm Fracture, Distal Radius Fracture
- Being tested
- Non-surgical treatment, Surgical treatment
- Keywords
- Forearm injuries, Wrist injuries, Salter-Harris fractures, Closed fracture reduction, Child, Bone remodeling
- Medical subject headings
- Wrist Fractures, Forearm Injuries, Wrist Injuries, Salter-Harris Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-surgical treatmentProcedure or surgery
If allocated to non-surgical group, cast optimization in the outpatient clinic may be necessary if the cast from the emergency room is considered insufficient.
Surgical treatmentProcedure or surgery
Closed reduction with or without fixation
| Study group | Role | What they receive |
|---|---|---|
| Non-surgical | Experimental | No reduction. Application of a cast. Receives: Procedure: Non-surgical treatment |
| Surgical | Active comparator | Closed reduction under general anesthesia with or without additional pin fixation of surgeons' choice followed by cast immobilization. Receives: Procedure: Surgical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
QuickDASH
Reporting of disability experienced and monitoring changes in symptoms and function over time. The patient (with help by parents if the patient is too young to self-report) rates each item according to the perceived degree of severity using a 5-point Likert Scale. Then, the overall score is transformed to a score between 0 and 100 (0 = no disability, 100 = maximum disability) according to the algorithm [(sum of responses N/N)-1]*25, where N is equal to the number of responses.
Measured: 12 months
Secondary outcomes (3)
QuickDASH
Reporting of disability experienced and monitoring changes in symptoms and function over time. The patient (with help by parents if the patient is too young to self-report) rates each item according to the perceived degree of severity using a 5-point Likert Scale. Then, the overall score is transformed to a score between 0 and 100 (0 = no disability, 100 = maximum disability) according to the algorithm [(sum of responses N/N)-1]*25, where N is equal to the number of responses.
Measured: 3 and 6 months
EQ-5D-Y
Health-related quality of life. The questionnaire consists of two parts:
- the descriptive system which assesses health in five dimensions (Mobility; Looking After Myself; Doing Usual Activities; Having Pain or Discomfort; Feeling Worried, Sad or Unhappy).
- A visual analogue scale (VAS) on which the respondent rates their perceived health from 0 (the worst imaginable health) to 100 (the best imaginable health)
Measured: 3, 6 and 12 months
Wong-Baker Faces Pain Rating Scale (WBS)
A self-reported tool to assess pain using a series of six facial expressions to illustrate the degree of pain intensity.
Measured: 3, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start7 Sep 2023
- Primary completionJan 2026 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (38)Papers the sponsor has linked to this study.
- Other trials for Distal Forearm FractureStudies of the same condition, open and under way.
- More trials run by Zealand University HospitalThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katrine Rønn Abildgaard, Zealand University Hospital
- Investigators
- Stig Brorson, MD PhD DMSc, Study director, Zealand University HospitalKatrine R. Abildgaard, MD, Principal investigator, Zealand University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05736068
- Sponsor's protocol ID
- REG-099-2022
- Acronym
- CASTING
- Status last verified
- Jan 2025
- First submitted
- 10 Feb 2023
- Last updated
- 27 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hedstrom EM, Svensson O, Bergstrom U, Michno P. Epidemiology of fractures in children and adolescents. Acta Orthop. 2010 Feb;81(1):148-53. doi: 10.3109/17453671003628780.
PubMed 20175744Hove 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 17940779Laaksonen T, Kosola J, Nietosvaara N, Puhakka J, Nietosvaara Y, Stenroos A. Epidemiology, Treatment, and Treatment Quality of Overriding Distal Metaphyseal Radial Fractures in Children and Adolescents. J Bone Joint Surg Am. 2022 Feb 2;104(3):207-214. doi: 10.2106/JBJS.21.00850.
PubMed 34780389Handoll HH, Elliott J, Iheozor-Ejiofor Z, Hunter J, Karantana A. Interventions for treating wrist fractures in children. Cochrane Database Syst Rev. 2018 Dec 19;12(12):CD012470. doi: 10.1002/14651858.CD012470.pub2.
PubMed 30566764Proctor MT, Moore DJ, Paterson JM. Redisplacement after manipulation of distal radial fractures in children. J Bone Joint Surg Br. 1993 May;75(3):453-4. doi: 10.1302/0301-620X.75B3.8496221.
PubMed 8496221McLauchlan GJ, Cowan B, Annan IH, Robb JE. Management of completely displaced metaphyseal fractures of the distal radius in children. A prospective, randomised controlled trial. J Bone Joint Surg Br. 2002 Apr;84(3):413-7. doi: 10.1302/0301-620x.84b3.11432.
PubMed 12002503Gibbons CL, Woods DA, Pailthorpe C, Carr AJ, Worlock P. The management of isolated distal radius fractures in children. J Pediatr Orthop. 1994 Mar-Apr;14(2):207-10. doi: 10.1097/01241398-199403000-00014.
PubMed 8188835Wendling-Keim DS, Wieser B, Dietz HG. Closed reduction and immobilization of displaced distal radial fractures. Method of choice for the treatment of children? Eur J Trauma Emerg Surg. 2015 Aug;41(4):421-8. doi: 10.1007/s00068-014-0483-7. Epub 2014 Dec 19.
PubMed 26038007Colaris JW, Allema JH, Biter LU, de Vries MR, van de Ven CP, Bloem RM, Kerver AJ, Reijman M, Verhaar JA. Re-displacement of stable distal both-bone forearm fractures in children: a randomised controlled multicentre trial. Injury. 2013 Apr;44(4):498-503. doi: 10.1016/j.injury.2012.11.001. Epub 2012 Dec 3.
PubMed 23217981Zamzam MM, Khoshhal KI. Displaced fracture of the distal radius in children: factors responsible for redisplacement after closed reduction. J Bone Joint Surg Br. 2005 Jun;87(6):841-3. doi: 10.1302/0301-620X.87B6.15648.
PubMed 15911670McQuinn AG, Jaarsma RL. Risk factors for redisplacement of pediatric distal forearm and distal radius fractures. J Pediatr Orthop. 2012 Oct-Nov;32(7):687-92. doi: 10.1097/BPO.0b013e31824b7525.
PubMed 22955532Miller BS, Taylor B, Widmann RF, Bae DS, Snyder BD, Waters PM. Cast immobilization versus percutaneous pin fixation of displaced distal radius fractures in children: a prospective, randomized study. J Pediatr Orthop. 2005 Jul-Aug;25(4):490-4. doi: 10.1097/01.bpo.0000158780.52849.39.
PubMed 15958902Wilkins KE. Principles of fracture remodeling in children. Injury. 2005 Feb;36 Suppl 1:A3-11. doi: 10.1016/j.injury.2004.12.007.
PubMed 15652934Do TT, Strub WM, Foad SL, Mehlman CT, Crawford AH. Reduction versus remodeling in pediatric distal forearm fractures: a preliminary cost analysis. J Pediatr Orthop B. 2003 Mar;12(2):109-15. doi: 10.1097/01.bpb.0000043725.21564.7b.
PubMed 12584495Laaksonen T, Puhakka J, Stenroos A, Kosola J, Ahonen M, Nietosvaara Y. Cast immobilization in bayonet position versus reduction and pin fixation of overriding distal metaphyseal radius fractures in children under ten years of age: a case control study. J Child Orthop. 2021 Feb 1;15(1):63-69. doi: 10.1302/1863-2548.15.200171.
PubMed 33643460
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Casting of Displaced Pediatric Distal Forearm Fractures Non-inferior to Reduction in General Anesthesia? A Pragmatic, Randomized, Controlled Non-inferiority Multicenter Trial
- ClinicalTrials.gov ID
- NCT05736068
- Acronym / sponsor ID
- CASTING / REG-099-2022
- Conditions
- Distal Forearm Fracture, Distal Radius Fracture
- Keywords
- Forearm injuries, Wrist injuries, Salter-Harris fractures, Closed fracture reduction, Child, Bone remodeling
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Collaborators
- Aalborg University Hospital, Aarhus University Hospital, Odense University Hospital
- Study start
- 7 Sep 2023 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 21 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.
Treatment of displaced distal forearm fractures (DFF) in children have traditionally been closed reduction and pin fixation, although they might heal and remodel without manipulation, with no functional impairment. No randomized controlled trials (RCTs) have been published comparing the patient-reported functional outcome after non-surgical and surgical treatment of displaced DFF in children.
This is a multicentre RCT. The aim of the trial is to investigate the patient-reported functional outcome after non-surgical treatment of displaced distal forearm fractures (DFF) in children. We will include 44 children aged 4-10 years with a displaced DFF. They will be offered inclusion, if the on-duty orthopedic surgeon finds indication for surgical intervention. If the parents/guardians consent to participate, the children will be allocated equally to non-surgical treatment (intervention) or surgical treatment of surgeon's choice (comparator). We will follow the children during one year, where they will be seen after 4 weeks, 3, 6 and 12 months. The primary outcome is the between-group difference in 12 months Quick Disabilities Arm Shoulder and Hand (QuickDASH) score.
Detailed description
Pediatric distal forearm fractures (DFF) are very common and accounts for 25-30% of all fractures in children.(1,2) Up to half of all pediatric DFF are displaced to an extent where surgery has been the preferred treatment option.(3) However, surgery does come with a cost.
The most common treatment of displaced pediatric DFF has long been closed reduction with or without pin fixation (or in rare cases plate and screw fixation) under general anesthesia, followed by immobilization in a cast.(4) Pin-related complications vary from 4-23%, depending on what is reported as complications,(5-11) and up to 40% has been reported when including re-displacements.(12) The insertion of a metal wire or plate also requires subsequent procedures to remove these implants again.
Numerous small cohort studies and case series have found pin fixation advantageous in achieving anatomic reduction and avoiding re-displacement.(5-11) However, whether anatomic reduction and stabilization is important regarding the patient-reported functional outcome has not been investigated since most studies use only radiographic or objective measures (e.g. range of motion). In addition, children's bones, and in particular the metaphysis and epiphysis, have a unique ability to heal and remodel throughout the growth period until puberty.(13) Almost 20 years ago, Do et al. (14) stated that "the tremendous capacity of distal metaphyseal radius fractures to heal and remodel makes this one of the most rewarding fractures to treat non-operatively. […]". In accordance with Do et al., other studies indicate that displaced DFF fractures in prepubertal children might heal without manipulation, and that most displaced fractures will remodel within a year or two to almost anatomical position with no functional impairment.(14-17) Although most surgeons are aware that children's bones have this remodeling potential, they still find it challenging to deal with the uncertainty of whether the bone will actually remodel to an acceptable position. Furthermore, surgeons might have difficulties with how families will react to the waiting time until the misaligned arm looks normal again.
If non-surgical treatment of displaced pediatric DFF were more common, the costs associated with surgery could be minimized. Unfortunately, there is limited evidence to guide the decision to operate or not. The available studies are typically small, retrospective cohort studies or case series of low quality with no predefined follow-up or outcome measures. To our knowledge, there are no published randomized controlled trials (RCTs) comparing non-surgical treatment with surgical treatment, and no studies report outcomes from the patient's perspective.
The aim of this trial is to investigate the patient-reported functional outcome after non-surgical treatment of displaced DFF in children aged 4-10 years. Our hypothesis is, that casting without manipulation is non-inferior to surgical treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-surgical | Experimental | Procedure: Non-surgical treatmentNo reduction. Application of a cast. |
| Surgical | Active comparator | Procedure: Surgical treatmentClosed reduction under general anesthesia with or without additional pin fixation of surgeons' choice followed by cast immobilization. |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children 4-10 years of age with open physes
- Fractures in the distal metaphyseal radius (with or without concomitant ulna fracture), including extraarticular physeal fractures (SH I-II)
- The on-duty surgeon finds reduction under anesthesia with or without fixation indicated
Key exclusion criteria (9 listed)
- Open fractures
- Nerve or vascular affection
- All intraarticular fractures including SH III-V
- Ulnar physeal fractures
- Polytrauma
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 |
|---|---|---|
| Non-surgical treatmentIf allocated to non-surgical group, cast optimization in the outpatient clinic may be necessary if the cast from the emergency room is considered insufficient. | Procedure or surgery | Non-surgical |
| Surgical treatmentClosed reduction with or without fixation | Procedure or surgery | Surgical |
Primary outcome
QuickDASH
Time frame: 12 months
Reporting of disability experienced and monitoring changes in symptoms and function over time. The patient (with help by parents if the patient is too young to self-report) rates each item according to the perceived degree of severity using a 5-point Likert Scale. Then, the overall score is transformed to a score between 0 and 100 (0 = no disability, 100 = maximum disability) according to the algorithm [(sum of responses N/N)-1]*25, where N is equal to the number of responses.
3 secondary outcomes
QuickDASH
Time frame: 3 and 6 months
EQ-5D-Y
Time frame: 3, 6 and 12 months
Wong-Baker Faces Pain Rating Scale (WBS)
Time frame: 3, 6 and 12 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 27 Jan 2025.
- Background: PubMed 20175744Hedstrom EM, Svensson O, Bergstrom U, Michno P. Epidemiology of fractures in children and adolescents. Acta Orthop. 2010 Feb;81(1):148-53. doi: 10.3109/17453671003628780.
- Background: PubMed 17940779Hove 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.
- Background: PubMed 34780389Laaksonen T, Kosola J, Nietosvaara N, Puhakka J, Nietosvaara Y, Stenroos A. Epidemiology, Treatment, and Treatment Quality of Overriding Distal Metaphyseal Radial Fractures in Children and Adolescents. J Bone Joint Surg Am. 2022 Feb 2;104(3):207-214. doi: 10.2106/JBJS.21.00850.
- Background: PubMed 30566764Handoll HH, Elliott J, Iheozor-Ejiofor Z, Hunter J, Karantana A. Interventions for treating wrist fractures in children. Cochrane Database Syst Rev. 2018 Dec 19;12(12):CD012470. doi: 10.1002/14651858.CD012470.pub2.
- Background: PubMed 8496221Proctor MT, Moore DJ, Paterson JM. Redisplacement after manipulation of distal radial fractures in children. J Bone Joint Surg Br. 1993 May;75(3):453-4. doi: 10.1302/0301-620X.75B3.8496221.
- Background: PubMed 12002503McLauchlan GJ, Cowan B, Annan IH, Robb JE. Management of completely displaced metaphyseal fractures of the distal radius in children. A prospective, randomised controlled trial. J Bone Joint Surg Br. 2002 Apr;84(3):413-7. doi: 10.1302/0301-620x.84b3.11432.
- Background: PubMed 8188835Gibbons CL, Woods DA, Pailthorpe C, Carr AJ, Worlock P. The management of isolated distal radius fractures in children. J Pediatr Orthop. 1994 Mar-Apr;14(2):207-10. doi: 10.1097/01241398-199403000-00014.
- Background: PubMed 26038007Wendling-Keim DS, Wieser B, Dietz HG. Closed reduction and immobilization of displaced distal radial fractures. Method of choice for the treatment of children? Eur J Trauma Emerg Surg. 2015 Aug;41(4):421-8. doi: 10.1007/s00068-014-0483-7. Epub 2014 Dec 19.
- Background: PubMed 23217981Colaris JW, Allema JH, Biter LU, de Vries MR, van de Ven CP, Bloem RM, Kerver AJ, Reijman M, Verhaar JA. Re-displacement of stable distal both-bone forearm fractures in children: a randomised controlled multicentre trial. Injury. 2013 Apr;44(4):498-503. doi: 10.1016/j.injury.2012.11.001. Epub 2012 Dec 3.
- Background: PubMed 15911670Zamzam MM, Khoshhal KI. Displaced fracture of the distal radius in children: factors responsible for redisplacement after closed reduction. J Bone Joint Surg Br. 2005 Jun;87(6):841-3. doi: 10.1302/0301-620X.87B6.15648.
- Background: PubMed 22955532McQuinn AG, Jaarsma RL. Risk factors for redisplacement of pediatric distal forearm and distal radius fractures. J Pediatr Orthop. 2012 Oct-Nov;32(7):687-92. doi: 10.1097/BPO.0b013e31824b7525.
- Background: PubMed 15958902Miller BS, Taylor B, Widmann RF, Bae DS, Snyder BD, Waters PM. Cast immobilization versus percutaneous pin fixation of displaced distal radius fractures in children: a prospective, randomized study. J Pediatr Orthop. 2005 Jul-Aug;25(4):490-4. doi: 10.1097/01.bpo.0000158780.52849.39.
- 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.
Stig Brorson, MD PhD DMSc study director
Zealand University Hospital
Katrine R. Abildgaard, MD principal investigator
Zealand University Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-surgical treatment and Surgical treatment in people with Distal Forearm Fracture and Distal Radius Fracture, run by Zealand University Hospital at 4 sites in Denmark.
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 5 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 27 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Denmark. 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?
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?
QuickDASH (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 NCT05736068, which also lists 38 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 27 Jan 2025.