7-12 Year Old Clinical Trial
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.
| Status | Recruiting |
| Enrollment | 90 |
| Est. completion date | December 31, 2024 |
| Est. primary completion date | December 31, 2024 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 7 Years to 12 Years |
| Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
| Country | Name | City | State |
|---|---|---|---|
| Finland | HUS New Childrens Hospital | Helsinki | |
| Finland | Kuopio University Hospital | Kuopio | |
| Finland | Oulu University Hospital | Oulu | |
| Finland | Tampere University Hospital | Tampere | |
| Finland | Turku University Hospital | Turku |
| Lead Sponsor | Collaborator |
|---|---|
| Helsinki University Central Hospital |
Finland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. |
12 months | |
| Primary | Pro-supination | Difference (percent) in forearm pronation-supination range of motion (ROM) at one-year follow-up in comparison to uninjured side. | 12 months | |
| Secondary | 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. | 6 weeks, 3, 6 and 12 months | |
| Secondary | 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. | 6 weeks, 3, 6 and 12 months | |
| Secondary | 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 | 6 weeks, 3, 6 and 12 months | |
| Secondary | Need for re-interventions | Minimum value 0 no maximum value. Lower value indicates better outcome. | 6 weeks, 3, 6 and 12 months | |
| Secondary | 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) | 6 weeks, 3, 6 and 12 months | |
| Secondary | Adverse effects | adverse effects (wound infection, nerve or/and tendon damage) | 6 weeks, 3, 6 and 12 months | |
| Secondary | Cosmetic VAS | Minimum value 0 maximum value 10. Higher value indicates better satisfaction | 6 weeks, 3, 6 and 12 months | |
| Secondary | PROMIS Pediatric Item Bank v2.0 - Upper Extremity | Difference between treatment groups | 6 weeks, 3, 6 months | |
| Secondary | Upper limb ROM | Difference (percent) in elbow, wrist flexion extension and pronation-supination in comparison to uninjured side | 6 weeks, 3, 6 months | |
| Secondary | 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. | 6 weeks, 3, 6 and 12 months |