When children up to 11 years old break the bones in their wrists, do they need surgery to perfectly realign the bones, or will nature 'self-correct' the bones as they heal without restricting the use of the arm?

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2020
INTERVENTION: This trial will compare two approaches to treat displaced distal radius fractures in children aged 4‐10 years old inclusive. Participants are randomised to either: Non‐surgical casting: This technique involves the application of a plaster cast to hold the bone fragments in the optimal possible position using analgesia, but without giving medication to deliberately alter the conscious level of the child. This may be the initial plaster cast used to stabilise the fracture, or the plaster cast may be changed by the clinician to maximise patient comfort and fracture stability. Although the principles of applying a plaster cast are inherent in the technique, in this pragmatic trial the type of casting material, extent of the cast and the details of the technique will be left to the discretion of the treating clinician as per their usual technique. A record will be made of the cast details and any cast changes. The usual practice is for the plaster cast to be used for 4‐6 weeks. A procedure or operation: A procedure or operation will be performed (with or without fixation). The bones will be realigned under general anaesthesia or sedation altering the conscious state of the child. The method used to hold the bones in position will be at the discretion of the clinician; i.e. plaster cast alone, plaster cast and wires, plaster cast and plate. A record will be made of the operative details, the cast details and any cast changes. Following surgery, the usual practice is for the arm to be immobilised in a cast for 4‐6 weeks. Specific details on the techniques and materials used in theatre will be collected for each participant. CONDITION: Radius acute fracture ; Injury, Occupational Diseases, Poisoning PRIMARY OUTCOME: Functional recovery assessed using the Patient Report Outcomes Measurement System (PROMIS Bank v2.0) Upper Extremity Score for Children Computer Adaptive Test (CAT) at 3 months post‐treatment INCLUSION CRITERIA: 1. Male and female children aged 4 to 10 years inclusive 2. Parents/guardians willing and able to give informed consent for their child’s participation in the study 3. There is radiographic evidence of a severely displaced wrist fracture at or adjacent to the physis (Salter‐Harris II or a metaphyseal fracture); with or without a corresponding ulna fracture 4. The treating clinician believes that they may benefit from surgical reduction with or without fixation SECONDARY OUTCOME: ; 1. Upper extremity function is measured using the PROMIS Upper Extremity Score during the first year post‐treatment; 2. Pain is measured using the Wong‐Baker FACES Pain Scale (an ordinal assessment using a series of six facial‐expressions to illustrate the degree of pain intensity) during the first year post‐treatment; 3. Health‐related quality of life is measured using EQ‐5D‐Y (Youth version) between during the first year post‐treatment; 4. Complication rate, including re‐fracture, the need for further operative fixation and the absence of radiographic remodelling, measured through a qualitative assessment of radiographs by a surgeon consensus group up to 1‐year post‐treatment; 5. Cost‐effectiveness of the treatments to the NHS and the broader economy is measured by collecting resource use information, including inpatient/outpatient hospital attendance, other NHS or private services and out of pocket expenses up to 1‐year post‐treatment; 6. Parental satisfaction with the cosmetic appearance of the arm measured using a visual analogue score (VAS) during the first year post‐treatment; 7. Patient satisfaction with care measured using an ordinal satisfaction score during the first year post‐treatment; 8. An assessment of impact of injury, treatment and recovery on parent and child experience of daily life and the outcomes that are important to them will be measured through qualitative interview during the first year post‐treatment; 9. The barriers and facilitators to trial recruitment from parent/child and staff perspectives will be measured through qualitative interview during the first year post‐treatment; ; Long‐term outcomes to be reported separately:; 10. Longer‐term pain, function and complications will be measured using the methods described above (i.e. Wong‐Baker, PROMIS‐UE and complications record) annually up until 3 years post‐treatment;
Epistemonikos ID: 5e43b1728f7da3f35b29e77488f4e4f2c96e628e
First added on: Aug 24, 2024