Casting Versus Flexible Intramedullary Nailing in Displaced Pediatric Forearm Shaft Fractures
Study Details
Study Description
Brief 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. 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: FIN (Flexible intramedullary nail) 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. |
Procedure: Flexible intramedullary nail (FIN)
Both bone FIN
|
| Active Comparator: Long arm cast 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. |
Procedure: Reduction auder general anesthesia and long arm cast
Reduction and cast
|
| Other: Patient Choice 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. |
Procedure: Flexible intramedullary nail (FIN)
Both bone FIN
|
| Other: Patient Choice cast 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. |
Procedure: Reduction auder general anesthesia and long arm cast
Reduction and cast
|
Outcome Measures
Primary Outcome Measures
- PROMIS Pediatric Item Bank v2.0 - Upper Extremity [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 [12 months]
Difference (percent) in forearm pronation-supination range of motion (ROM) at one-year follow-up in comparison to uninjured side.
Secondary Outcome Measures
- Quick Disabilities of the Arm, Shoulder and Hand score [6 weeks, 3, 6 and 12 months]
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.
- Measurement Model for the Pediatric Quality of Life Inventory (PedsQL) [6 weeks, 3, 6 and 12 months]
Minimum value is 0 and maximum value is 100. Higher score indicates better health related quality of life.
- Measurement Model for the Pediatric Quality of Life Inventory Pediatric Pain Questionaire (PEDS QL PPQ) [6 weeks, 3, 6 and 12 months]
Minimum value 0 maximum value 10. Higher value indicates higher pain intensity
- Need for re-interventions [6 weeks, 3, 6 and 12 months]
Minimum value 0 no maximum value. Lower value indicates better outcome.
- Rate of participants with malunion [6 weeks, 3, 6 and 12 months]
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)
- Adverse effects [6 weeks, 3, 6 and 12 months]
adverse effects (wound infection, nerve or/and tendon damage)
- Cosmetic VAS [6 weeks, 3, 6 and 12 months]
Minimum value 0 maximum value 10. Higher value indicates better satisfaction
- PROMIS Pediatric Item Bank v2.0 - Upper Extremity [6 weeks, 3, 6 months]
Difference between treatment groups
- Upper limb ROM [6 weeks, 3, 6 months]
Difference (percent) in elbow, wrist flexion extension and pronation-supination in comparison to uninjured side
- Return to sport/musical instrument and level [6 weeks, 3, 6 and 12 months]
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.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | HUS New Childrens Hospital | Helsinki | Finland | 00029HUS | |
| 2 | Kuopio University Hospital | Kuopio | Finland | ||
| 3 | Oulu University Hospital | Oulu | Finland | ||
| 4 | Tampere University Hospital | Tampere | Finland | ||
| 5 | Turku University Hospital | Turku | Finland |
Sponsors and Collaborators
- Helsinki University Central Hospital
Investigators
- Study Director: Ilkka Helenius, MD, Helsinki University Central Hospital
- Principal Investigator: Petra Grahn, MD, Helsinki University Central Hospital
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 78/1801/2020