Radius Fracture DistalNCT05008029
Immobilization Without Reduction vs. Reduction Under General Anesthesia in Metaphyseal Fractures of the Distal Radius
A study testing In situ immobilization and Reduction under general anesthesia in people with Radius Fracture Distal, run by Instituto de Ortopedia Infantil Roosevelt at 1 site in Colombia.
Trial summary
Distal radius metaphyseal fractures are the most frequent in the pediatric population. The current treatment for angulated or shortened fractures is effective. Still, it exposes children to anesthetic risks supported by the pain generated by the reduction. Read more about this study
- Who is it for?
- Ages 5 to 10 years
- Conditions the study is for
- Radius Fracture Distal
- What is being tested?
- In situ immobilization and Reduction under general anesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteColombia
- Study dates
- 15 Jun 2021to 15 Jul 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 5 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children from 5 years to 10 years
- Unilateral metaphyseal distal radius fracture
- Fracture shortening of 0 to 10mm or angulation of 10 ° to 20 ° in the oblique plane. (AO 23-M 2-3 or 23r-M 2-3)
- Admission in the first 14 days after the fracture
Who cannot join
- Polytrauma: Injury Severity Score (ISS)> 16
- Associated fracture in the same limb.
- Neuromuscular pathology (e.g., cerebral palsy, spinal muscular atrophy, Duchenne disease)
- Open fractures.
- History of fractures, septic arthritis, or osteomyelitis in the same limb.
- Neurological or vascular injury in the fractured upper limb.
- Known alteration of bone metabolism (e.g., osteogenesis imperfecta, rickets, osteopetrosis, skeletal dysplasias, lysosomal storage diseases).
- Congenital longitudinal deficiency.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cast Immobilization Without Reduction vs. Reduction Under General Anesthesia in Metaphyseal Fractures of the Distal Radius.
Distal radius metaphyseal fractures are the most frequent in the pediatric population. The current treatment for angulated or shortened fractures is effective. Still, it exposes children to anesthetic risks supported by the pain generated by the reduction. Due to the excellent remodeling capacity of bone at an early age, it is questionable whether an anatomical reduction is necessary.
The clinical experiment's objective is to compare the functional result of immobilization without reducing angulated or displaced metaphyseal fractures of the distal radius against fractures brought to reduction under general anesthesia. Means difference in function subdomain of the upper limb of the PROMIS® scale is the primary outcome. The secondary results are wrist mobility, radius alignment, wrist articular relationships, and surgical complications.
Read the detailed description
The participant will be recruited in one center. If participants and their parents accept to participate in this study, treatments will be randomly allocated using the Big Stick Design technique with a maximum tolerated imbalance of 2. The sequence will be generated by a research assistant who is completely independent of the study, does not know the purpose of the study and the interventions. Each of the random numbers will be stored in an opaque envelope sealed externally with the order in which they should be opened.
Patient registration and follow-up information will be stored in REDCap®. Clinical and radiographic outcomes will be evaluated.
- Conditions
- Radius Fracture Distal
- Being tested
- In situ immobilization, Reduction under general anesthesia
- Keywords
- radius fracture, children, conservative treatment, distal radius
- Medical subject headings
- Wrist Fractures, Radius Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In situ immobilizationProcedure or surgery
Immobilization with an above-elbow cast. A 2, 3, or 4-year orthopedic resident or pediatric orthopedic fellow supervised by a pediatric orthopedic surgeon will perform the procedure without reduction, sedation, or anesthesia. Analgesia will be administered with paracetamol at doses of 10-15 mg/kg/dose or tramadol 0.5-1mg/kg/dose. Supposing immobilization is not satisfactory, or the patient or family member does not authorize the procedure to be carried out by staff in training. In that case, the procedure will be supported or carried out by the pediatric orthopedic surgeon.
Reduction under general anesthesiaProcedure or surgery
The participants will receive paracetamol at 10-15 mg/kg/dose or tramadol 0.5-1 mg/kg/dose for pain control until the time of surgery. Under general anesthesia, radius closed reduction, and above-elbow casting will be performed. After the reduction maneuvers, the radius reduction is satisfactory if the translation in the coronal and sagittal planes of less than 50% and angulation in the same planes is less than 10 °. If the radius does not remain reduced, it is unstable. Unstable fractures require percutaneous fixation with K-wires, a sugar tong splint immobilization, and a nerve block. The procedures will be carried out by a 2, 3, or 4-year orthopedic resident or pediatric orthopedic fellow under the supervision of a child orthopedist. Suppose reduction is not satisfactory or the patient or parent doesn´t authorize the procedure performed by personnel in training. In that case, the procedure will be supported or carried out by the pediatric orthopedic surgeon.
| Study group | Role | What they receive |
|---|---|---|
| In situ immobilization | Experimental | Immobilization without reducing the radius fracture and above-elbow casting. Receives: Procedure: In situ immobilization |
| Reduction under general anesthesia | Active comparator | Radius closed reduction under general anesthesia and above-elbow casting. Percutaneous fixation with K-wires, a sugar tong splint immobilization, and a nerve block if needed. Receives: Procedure: Reduction under general anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper limb function
Assess upper extremity function with PROMIS Physical Function, Upper Extremity subdomain. The investigators will apply the parent-proxy version between 5 and 7 years old and the pediatric version between 8 and 10.
Measured: 6 months
Secondary outcomes (3)
Wrist range of motion
Wrist passive degrees of flexion and extension measured with a goniometer aligned with the forearm axis and the second metacarpal.
Pronation and supination. The investigators will ask the patient to hold a pencil vertically with the ulnar edge of the forearm on the table and the elbow flexed 90 °. The wrist is rotated medially or laterally, respectively. One arm of the goniometer is placed on the table and the other is aligned with the pencil, the degrees obtained must be subtracted from 90 °.
Measured: 3 and 6 months
Ulnar variance
The investigators will consider the ulnar variance as the distance between the most distal aspect of the metaphysis of the radius and the ulna according to the Hafner distal-distal method (DIDI).
Measured: 9 months
Deformity
Angulation in the oblique plane
Measured: 2 weeks, 3 months and 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2021
- Study start15 Jun 2021
- Primary completion15 Apr 2024
- Study completion15 Jul 2024
Why it stopped: Recruitment time ended, but sample size was not completed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Radius Fracture DistalStudies of the same condition, open and under way.
- 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
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Ortopedia Infantil Roosevelt
- Sponsor type
- University, hospital or other
- Collaborators
- Pontificia Universidad Javeriana
- Responsible party
- Sponsor
- Investigators
- Maria F Garcia, MD, Principal investigator, Instituto Roosevelt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05008029
- Sponsor's protocol ID
- 2021012101
- Status last verified
- Oct 2024
- First submitted
- 10 Jun 2021
- Last updated
- 3 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study information will be available through the institutional website.
Publications
Marson BA, Ng JWG, Craxford S, Chell J, Lawniczak D, Price KR, Ollivere BJ, Hunter JB. Treatment of completely displaced distal radial fractures with a straight plaster or manipulation under anaesthesia. Bone Joint J. 2021 May;103-B(5):902-907. doi: 10.1302/0301-620X.103B.BJJ-2020-1740.R1. Epub 2021 Mar 12.
PubMed 33709769Garcia-Rueda MF, Bohorquez-Penaranda AP, Gil-Laverde JFA, Aguilar-Sierra FJ, Mendoza-Pulido C. Casting Without Reduction Versus Closed Reduction With or Without Fixation in the Treatment of Distal Radius Fractures in Children: Protocol for a Randomized Noninferiority Trial. JMIR Res Protoc. 2022 Apr 14;11(4):e34576. doi: 10.2196/34576.
PubMed 35436224
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cast Immobilization Without Reduction vs. Reduction Under General Anesthesia in Metaphyseal Fractures of the Distal Radius.
- ClinicalTrials.gov ID
- NCT05008029
- Acronym / sponsor ID
- 2021012101
- Conditions
- Radius Fracture Distal
- Keywords
- radius fracture, children, conservative treatment, distal radius
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment time ended, but sample size was not completed.
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Instituto de Ortopedia Infantil RooseveltUniversity, hospital or other
- Collaborators
- Pontificia Universidad Javeriana
- Study start
- 15 Jun 2021 (actual)
- Primary completion
- 15 Apr 2024 (actual)
- Study completion
- 15 Jul 2024 (actual)
- First posted
- 17 Aug 2021 (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.
Distal radius metaphyseal fractures are the most frequent in the pediatric population. The current treatment for angulated or shortened fractures is effective. Still, it exposes children to anesthetic risks supported by the pain generated by the reduction. Due to the excellent remodeling capacity of bone at an early age, it is questionable whether an anatomical reduction is necessary.
The clinical experiment's objective is to compare the functional result of immobilization without reducing angulated or displaced metaphyseal fractures of the distal radius against fractures brought to reduction under general anesthesia. Means difference in function subdomain of the upper limb of the PROMIS® scale is the primary outcome. The secondary results are wrist mobility, radius alignment, wrist articular relationships, and surgical complications.
Detailed description
The participant will be recruited in one center. If participants and their parents accept to participate in this study, treatments will be randomly allocated using the Big Stick Design technique with a maximum tolerated imbalance of 2. The sequence will be generated by a research assistant who is completely independent of the study, does not know the purpose of the study and the interventions. Each of the random numbers will be stored in an opaque envelope sealed externally with the order in which they should be opened.
Patient registration and follow-up information will be stored in REDCap®. Clinical and radiographic outcomes will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| In situ immobilization | Experimental | Procedure: In situ immobilizationImmobilization without reducing the radius fracture and above-elbow casting. |
| Reduction under general anesthesia | Active comparator | Procedure: Reduction under general anesthesiaRadius closed reduction under general anesthesia and above-elbow casting. Percutaneous fixation with K-wires, a sugar tong splint immobilization, and a nerve block if needed. |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children from 5 years to 10 years
- Unilateral metaphyseal distal radius fracture
- Fracture shortening of 0 to 10mm or angulation of 10 ° to 20 ° in the oblique plane. (AO 23-M 2-3 or 23r-M 2-3)
- Admission in the first 14 days after the fracture
Key exclusion criteria (8 listed)
- Polytrauma: Injury Severity Score (ISS)> 16
- Associated fracture in the same limb.
- Neuromuscular pathology (e.g., cerebral palsy, spinal muscular atrophy, Duchenne disease)
- Open fractures.
- History of fractures, septic arthritis, or osteomyelitis in the same limb.
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 |
|---|---|---|
| In situ immobilizationImmobilization with an above-elbow cast. A 2, 3, or 4-year orthopedic resident or pediatric orthopedic fellow supervised by a pediatric orthopedic surgeon will perform the procedure without reduction, sedation, or anesthesia. Analgesia will be administered with paracetamol at doses of 10-15 mg/kg/dose or tramadol 0.5-1mg/kg/dose. Supposing immobilization is not satisfactory, or the patient or family member does not authorize the procedure to be carried out by staff in training. In that case, the procedure will be supported or carried out by the pediatric orthopedic surgeon. | Procedure or surgery | In situ immobilization |
| Reduction under general anesthesiaThe participants will receive paracetamol at 10-15 mg/kg/dose or tramadol 0.5-1 mg/kg/dose for pain control until the time of surgery. Under general anesthesia, radius closed reduction, and above-elbow casting will be performed. After the reduction maneuvers, the radius reduction is satisfactory if the translation in the coronal and sagittal planes of less than 50% and angulation in the same planes is less than 10 °. If the radius does not remain reduced, it is unstable. Unstable fractures require percutaneous fixation with K-wires, a sugar tong splint immobilization, and a nerve block. The procedures will be carried out by a 2, 3, or 4-year orthopedic resident or pediatric orthopedic fellow under the supervision of a child orthopedist. Suppose reduction is not satisfactory or the patient or parent doesn´t authorize the procedure performed by personnel in training. In that case, the procedure will be supported or carried out by the pediatric orthopedic surgeon. | Procedure or surgery | Reduction under general anesthesia |
Primary outcome
Upper limb function
Time frame: 6 months
Assess upper extremity function with PROMIS Physical Function, Upper Extremity subdomain. The investigators will apply the parent-proxy version between 5 and 7 years old and the pediatric version between 8 and 10.
3 secondary outcomes
Wrist range of motion
Time frame: 3 and 6 months
Ulnar variance
Time frame: 9 months
Deformity
Time frame: 2 weeks, 3 months and 9 months
Results and safety
The study was stopped early (reason given: Recruitment time ended, but sample size was not completed.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2024.
- Background: PubMed 33709769Marson BA, Ng JWG, Craxford S, Chell J, Lawniczak D, Price KR, Ollivere BJ, Hunter JB. Treatment of completely displaced distal radial fractures with a straight plaster or manipulation under anaesthesia. Bone Joint J. 2021 May;103-B(5):902-907. doi: 10.1302/0301-620X.103B.BJJ-2020-1740.R1. Epub 2021 Mar 12.
- Derived from this study: PubMed 35436224Garcia-Rueda MF, Bohorquez-Penaranda AP, Gil-Laverde JFA, Aguilar-Sierra FJ, Mendoza-Pulido C. Casting Without Reduction Versus Closed Reduction With or Without Fixation in the Treatment of Distal Radius Fractures in Children: Protocol for a Randomized Noninferiority Trial. JMIR Res Protoc. 2022 Apr 14;11(4):e34576. doi: 10.2196/34576.
- Individual participant dataSharing planned: Yes. Study information will be available through the institutional website.
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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.
Maria F Garcia, MD principal investigator
Instituto Roosevelt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing In situ immobilization and Reduction under general anesthesia in people with Radius Fracture Distal, run by Instituto de Ortopedia Infantil Roosevelt at 1 site in Colombia.
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 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: stopped early, as of the sponsor's last update on 3 Oct 2024. 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 Colombia. 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 was stopped early (reason given: Recruitment time ended, but sample size was not completed.). Results are not available in the source record.
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?
Upper limb function (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 NCT05008029, which also lists 2 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 3 Oct 2024.