Both Bone Forearm FractureNCT04664517
Casting Versus Flexible Intramedullary Nailing in Displaced Pediatric Forearm Shaft Fractures
A study testing Flexible intramedullary nail (FIN) and Reduction auder general anesthesia and long arm cast in people with Both Bone Forearm Fracture and AO Classification 22D/2.1-5.2, run by Helsinki University Central Hospital at 5 sites in Finland.
Trial summary
The forearm is the most common fracture location in children, with an increasing incidence. Displaced forearm shaft fractures have traditionally been treated with closed reduction and cast immobilization. Read more about this study
- Who is it for?
- Ages 7 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Both Bone Forearm Fracture, AO Classification 22D/2.1-5.2, 7-12 Year Old
- What is being tested?
- Flexible intramedullary nail (FIN) and Reduction auder general anesthesia and long arm cast
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 5 sitesFinland
- Study dates
- 1 May 2021to 31 Dec 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 7 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 7 to12 year old children
- Open distal radial physis
- Both bone forearm shaft fractures (AO-pediatric classification: 22D/2.1-5.2)
- More than 10 degrees of angulation
- with or without less than 10mm of shortening
Who cannot join
- Patients with bilateral fractures
- Gustilo-Anderson grade I-III open fracture
- Neurovascular deficit
- Compartment syndrome
- Pathologic fracture
- Patient not able to give a written informed consent
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Finland5 sites, 5 recruiting
- Recruiting
HUS New Childrens Hospital
Helsinki, 00029HUS
Petra Grahn, MD, +358 9 4711
Matti Ahonen, MD, + 358 9 4711
- Recruiting
Kuopio University Hospital
Kuopio
Yrjänä Nietosvaara, MD
- Not yet recruiting
Oulu University Hospital
Oulu
Juha-Jaakko Sinikumpu, MD
- Not yet recruiting
Tampere University Hospital
Tampere
Anne Salonen, MD
- Recruiting
Turku University Hospital
Turku
Johanna Syvänen, MD
About this study
Official title: Casting Versus Flexible Intramedullary Nailing in Displaced Forearm Shaft Fractures in 7 to 12 Years Old Children: A Study Protocol for a Randomized Controlled Trial
The forearm is the most common fracture location in children, with an increasing incidence. Displaced forearm shaft fractures have traditionally been treated with closed reduction and cast immobilization. Diaphyseal fractures in children have poor remodeling capacity, and malunion can thus cause permanent cosmetic and functional disability. Internal fixation especially with flexible intramedullary nails has gained increasing popularity, without evidence of a better outcome compared to closed reduction and cast immobilization.
Read the detailed description
This is a multicenter, randomized superiority trial comparing closed reduction and cast immobilization to flexible intramedullary nails in 7-12 year old children with > 10° of angulation and/or > 10mm of shortening in displaced both bone forearm shaft fractures (AO-pediatric classification: 22D/2.1-5.2). A total of 78 patients with minimum 2 years of expected growth left are randomized in 1:1 ratio to either treatment group. The study has a parallel non-randomized patient preference arm. Both treatments are performed under general anesthesia. In the cast group a long arm cast is applied for 6 weeks. The flexible intramedullary nail group is immobilized in a collar and cuff sling for 4 weeks. Data is collected at baseline and at each follow-up until 1 year.
Primary outcome is 1) PROMIS Pediatric Item Bank v2.0 - Upper Extremity and 2) forearm pronation-supination range of motion at one-year follow-up. Secondary outcomes are Quick DASH, Pediatric pain questionnaire, Cosmetic VAS, wrist range of motion as well as any complications (malunion, delayed union, non-union or deep wound infection, peripheral nerve injury, need for re-intervention during 1-year follow-up) and costs of treatment.
The investigators hypothesize that flexible intramedullary nailing results in a superior outcome.
- Being tested
- Flexible intramedullary nail (FIN), Reduction auder general anesthesia and long arm cast
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flexible intramedullary nail (FIN)Procedure or surgery
Both bone FIN
Reduction auder general anesthesia and long arm castProcedure or surgery
Reduction and cast
| Study group | Role | What they receive |
|---|---|---|
| FIN (Flexible intramedullary nail) | Active comparator | Fracture reduction and fixation using flexible intramedullary nails. Nails size is 0.4 times the smallest diameter of the medullary canal of radius or ulna measured in radiographs. Receives: Procedure: Flexible intramedullary nail (FIN) |
| Long arm cast | Active comparator | Fractures are reduced under general anesthesia within 3 days from injury and a synthetic circular above elbow cast in neutral pro-supination is applied for six weeks. Receives: Procedure: Reduction auder general anesthesia and long arm cast |
| Patient Choice FIN | Other | Fracture reduction and fixation using flexible intramedullary nails. Nails size is 0.4 times the smallest diameter of the medullary canal of radius or ulna measured in radiographs. Receives: Procedure: Flexible intramedullary nail (FIN) |
| Patient Choice cast | Other | Fractures are reduced under general anesthesia within 3 days from injury and a synthetic circular above elbow cast in neutral pro-supination is applied for six weeks. Receives: Procedure: Reduction auder general anesthesia and long arm cast |
What is being measured
The primary outcome is the main question the study is designed to answer.
PROMIS Pediatric Item Bank v2.0 - Upper Extremity
We aim to confirm that 75 percent of FIN patients have a better PROMIS UE score than what the mean score of the cast patients will be assuming both groups have the same standard deviation.
PROMIS (Patient-Reported Outcomes Measurement Information System) scores are normalized to a mean score of 50, standard deviation of 10, with a theoretical range of 0 to 100. A higher score corresponds to a greater amount of the domain being measured.
Measured: 12 months
Pro-supination
Difference (percent) in forearm pronation-supination range of motion (ROM) at one-year follow-up in comparison to uninjured side.
Measured: 12 months
Secondary outcomes (10)
Quick Disabilities of the Arm, Shoulder and Hand score
Minimum value is 0 and maximum 100. Higher value indicates worse function. Statistically significant difference in QuickDASH score is 6.8 (18) at 12 months FU.
Measured: 6 weeks, 3, 6 and 12 months
Measurement Model for the Pediatric Quality of Life Inventory (PedsQL)
Minimum value is 0 and maximum value is 100. Higher score indicates better health related quality of life.
Measured: 6 weeks, 3, 6 and 12 months
Measurement Model for the Pediatric Quality of Life Inventory Pediatric Pain Questionaire (PEDS QL PPQ)
Minimum value 0 maximum value 10. Higher value indicates higher pain intensity
Measured: 6 weeks, 3, 6 and 12 months
Need for re-interventions
Minimum value 0 no maximum value. Lower value indicates better outcome.
Measured: 6 weeks, 3, 6 and 12 months
Rate of participants with malunion
malunion, delayed union (defined as nonunion at 3 months or later), pseudoarthrosis (defined as 3 cortices out of 4 not united at 6 months or later)
Measured: 6 weeks, 3, 6 and 12 months
Adverse effects
adverse effects (wound infection, nerve or/and tendon damage)
Measured: 6 weeks, 3, 6 and 12 months
Cosmetic VAS
Minimum value 0 maximum value 10. Higher value indicates better satisfaction
Measured: 6 weeks, 3, 6 and 12 months
PROMIS Pediatric Item Bank v2.0 - Upper Extremity
Difference between treatment groups
Measured: 6 weeks, 3, 6 months
Upper limb ROM
Difference (percent) in elbow, wrist flexion extension and pronation-supination in comparison to uninjured side
Measured: 6 weeks, 3, 6 months
Return to sport/musical instrument and level
Level of practiced sport or musical instrument before and at end of trial, as well as time from injury to return to hobby is registered.
Measured: 6 weeks, 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 posted11 Dec 2020
- Study start1 May 2021
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 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 Both Bone Forearm FractureStudies of the same condition, open and under way.
- More trials run by Helsinki University Central 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
- Model description
- multicenter, randomized superiority trial. Parallell patient choice arm.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Petra Grahn, Helsinki University Central Hospital
- Investigators
- Ilkka Helenius, MD, Study director, Helsinki University Central HospitalPetra Grahn, MD, Principal investigator, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04664517
- Sponsor's protocol ID
- 78/1801/2020
- Status last verified
- Sep 2024
- First submitted
- 6 Dec 2020
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data will be available upon request. Data will be delivered as anonymized.
Publications
Grahn P, Sinikumpu JJ, Nietosvaara Y, Syvanen J, Salonen A, Ahonen M, Helenius I. Casting versus flexible intramedullary nailing in displaced forearm shaft fractures in children aged 7-12 years: a study protocol for a randomised controlled trial. BMJ Open. 2021 Aug 20;11(8):e048248. doi: 10.1136/bmjopen-2020-048248.
PubMed 34417215
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Casting Versus Flexible Intramedullary Nailing in Displaced Forearm Shaft Fractures in 7 to 12 Years Old Children: A Study Protocol for a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04664517
- Acronym / sponsor ID
- 78/1801/2020
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 11 Dec 2020 (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 forearm is the most common fracture location in children, with an increasing incidence. Displaced forearm shaft fractures have traditionally been treated with closed reduction and cast immobilization. Diaphyseal fractures in children have poor remodeling capacity, and malunion can thus cause permanent cosmetic and functional disability. Internal fixation especially with flexible intramedullary nails has gained increasing popularity, without evidence of a better outcome compared to closed reduction and cast immobilization.
Detailed description
This is a multicenter, randomized superiority trial comparing closed reduction and cast immobilization to flexible intramedullary nails in 7-12 year old children with > 10° of angulation and/or > 10mm of shortening in displaced both bone forearm shaft fractures (AO-pediatric classification: 22D/2.1-5.2). A total of 78 patients with minimum 2 years of expected growth left are randomized in 1:1 ratio to either treatment group. The study has a parallel non-randomized patient preference arm. Both treatments are performed under general anesthesia. In the cast group a long arm cast is applied for 6 weeks. The flexible intramedullary nail group is immobilized in a collar and cuff sling for 4 weeks. Data is collected at baseline and at each follow-up until 1 year.
Primary outcome is 1) PROMIS Pediatric Item Bank v2.0 - Upper Extremity and 2) forearm pronation-supination range of motion at one-year follow-up. Secondary outcomes are Quick DASH, Pediatric pain questionnaire, Cosmetic VAS, wrist range of motion as well as any complications (malunion, delayed union, non-union or deep wound infection, peripheral nerve injury, need for re-intervention during 1-year follow-up) and costs of treatment.
The investigators hypothesize that flexible intramedullary nailing results in a superior outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- multicenter, randomized superiority trial. Parallell patient choice arm.
| Arm | Type | Receives |
|---|---|---|
| FIN (Flexible intramedullary nail) | Active comparator | Procedure: Flexible intramedullary nail (FIN)Fracture reduction and fixation using flexible intramedullary nails. Nails size is 0.4 times the smallest diameter of the medullary canal of radius or ulna measured in radiographs. |
| Long arm cast | Active comparator | Procedure: Reduction auder general anesthesia and long arm castFractures are reduced under general anesthesia within 3 days from injury and a synthetic circular above elbow cast in neutral pro-supination is applied for six weeks. |
| Patient Choice FIN | Other | Procedure: Flexible intramedullary nail (FIN)Fracture reduction and fixation using flexible intramedullary nails. Nails size is 0.4 times the smallest diameter of the medullary canal of radius or ulna measured in radiographs. |
| Patient Choice cast | Other | Procedure: Reduction auder general anesthesia and long arm castFractures are reduced under general anesthesia within 3 days from injury and a synthetic circular above elbow cast in neutral pro-supination is applied for six weeks. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 7 to12 year old children
- Open distal radial physis
- Both bone forearm shaft fractures (AO-pediatric classification: 22D/2.1-5.2)
- More than 10 degrees of angulation
- with or without less than 10mm of shortening
Key exclusion criteria (6 listed)
- Patients with bilateral fractures
- Gustilo-Anderson grade I-III open fracture
- Neurovascular deficit
- Compartment syndrome
- Pathologic fracture
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 |
|---|---|---|
| Flexible intramedullary nail (FIN)Both bone FIN | Procedure or surgery | FIN (Flexible intramedullary nail), Patient Choice FIN |
| Reduction auder general anesthesia and long arm castReduction and cast | Procedure or surgery | Long arm cast, Patient Choice cast |
Primary outcome
PROMIS Pediatric Item Bank v2.0 - Upper Extremity
Time frame: 12 months
We aim to confirm that 75 percent of FIN patients have a better PROMIS UE score than what the mean score of the cast patients will be assuming both groups have the same standard deviation. PROMIS (Patient-Reported Outcomes Measurement Information System) scores are normalized to a mean score of 50, standard deviation of 10, with a theoretical range of 0 to 100. A higher score corresponds to a greater amount of the domain being measured.
Pro-supination
Time frame: 12 months
Difference (percent) in forearm pronation-supination range of motion (ROM) at one-year follow-up in comparison to uninjured side.
10 secondary outcomes
Quick Disabilities of the Arm, Shoulder and Hand score
Time frame: 6 weeks, 3, 6 and 12 months
Measurement Model for the Pediatric Quality of Life Inventory (PedsQL)
Time frame: 6 weeks, 3, 6 and 12 months
Measurement Model for the Pediatric Quality of Life Inventory Pediatric Pain Questionaire (PEDS QL PPQ)
Time frame: 6 weeks, 3, 6 and 12 months
Need for re-interventions
Time frame: 6 weeks, 3, 6 and 12 months
Rate of participants with malunion
Time frame: 6 weeks, 3, 6 and 12 months
Adverse effects
Time frame: 6 weeks, 3, 6 and 12 months
Cosmetic VAS
Time frame: 6 weeks, 3, 6 and 12 months
PROMIS Pediatric Item Bank v2.0 - Upper Extremity
Time frame: 6 weeks, 3, 6 months
Upper limb ROM
Time frame: 6 weeks, 3, 6 months
Return to sport/musical instrument and level
Time frame: 6 weeks, 3, 6 and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Derived from this study: PubMed 34417215Grahn P, Sinikumpu JJ, Nietosvaara Y, Syvanen J, Salonen A, Ahonen M, Helenius I. Casting versus flexible intramedullary nailing in displaced forearm shaft fractures in children aged 7-12 years: a study protocol for a randomised controlled trial. BMJ Open. 2021 Aug 20;11(8):e048248. doi: 10.1136/bmjopen-2020-048248.
- Individual participant dataSharing planned: Yes. All data will be available upon request. Data will be delivered as anonymized.
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.
Ilkka Helenius, MD study director
Helsinki University Central Hospital
Petra Grahn, MD principal investigator
Helsinki University Central Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flexible intramedullary nail (FIN) and Reduction auder general anesthesia and long arm cast in people with Both Bone Forearm Fracture and AO Classification 22D/2.1-5.2, run by Helsinki University Central Hospital at 5 sites in Finland.
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 6 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Finland. 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 Petra Grahn, MD (+35894711, petra.grahn@hus.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PROMIS Pediatric Item Bank v2.0 - Upper Extremity (time frame: 12 months). The study lists 2 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 NCT04664517, 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 19 Sep 2024.