Casting Versus Percutaneus Pinning Treatment of Pediatric Overriding Distal Forearm Fractures
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|ClinicalTrials.gov Identifier: NCT04323410|
Recruitment Status : Recruiting
First Posted : March 26, 2020
Last Update Posted : July 1, 2020
|Condition or disease||Intervention/treatment||Phase|
|Pediatric Overriding Distal Metaphyseal Radius Fractures||Procedure: Cast immobilization Procedure: Percutaneus pinning||Not Applicable|
Overriding pediatric distal radius fractures have been managed with anatomical reduction performed under anesthesia with or without percutaneous pinning. This research protocol was developed due to good results reported on leaving the fractures in an overriding position.
In this randomized controlled trial, we will compare objective outcomes between casting in finger-trap traction without reduction versus closed reduction and percutaneous pin fixation of dorsally displaced, overriding distal metaphyseal radius fractures in children.
Inclusion criteria are patients younger than 11 years old (Tanner 0) with completely overriding distal radius fractures. At the emergency department patients are randomized into two groups: finger trap traction and cast immobilization (experimental group) and anatomic reduction and percutaneous pin fixation (control group).
The current controversy is whether cast immobilization alone is an adequate stabilization or whether percutaneous pin fixation is more appropriate for displaced, complete, distal forearm (overriding) metaphyseal fractures. The objectives of this trial are to compare the outcomes between conservative treatment with finger trap method for completely displaced distal radius fractures and surgical treatment with percutaneous pinning. Our null hypothesis is that there are no radiological or clinically relevant differences in outcome measures between the two treatment groups. We consider non-inferiority proven if there is no clinically significant difference at 6 months between the two treatments groups in the primary outcome: ratio (%) of forearm rotation and wrist extension-flexion range of motion (ROM) compared to the non-affected side at 6 months (non-inferiority margin 10%).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Non-inferiority randomized controlled trial|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||Casting in Finger-trap Traction Without Reduction Versus Closed Reduction and Percutaneous Pin Fixation of Dorsally Displaced, Overriding Distal Metaphyseal Radius Fractures in Under Eleven Years Old Children|
|Actual Study Start Date :||June 29, 2020|
|Estimated Primary Completion Date :||December 31, 2023|
|Estimated Study Completion Date :||December 31, 2025|
Experimental: Cast immobilization
In the casting group, padded synthetic dorsal above elbow and volar below elbow splints are applied in ED without local or general anesthesia. Dorsal displacement and shortening of the radius are not corrected, but the forearm is attempted to be manipulated straight during application of the splints. The casted forearm is then supported by a collar and cuff sling. Splints are removed in an outpatient clinic at 4 weeks.
Cast immobilization is discontinued after 4 weeks and when the fracture site is nontender. If palpated tenderness is still present, the patient is given a dorsal forearm splint which can be removed (maximum of 2 weeks usage).
Procedure: Cast immobilization
Cast immobilisation is done using finger trap traction. The fractured forearm is splinted above elbow with dorsal cast without attempted reduction.
Active Comparator: Percutaneus pinning
In the surgery group, a padded dorsal above elbow splint is applied in ED. Reduction and percutaneous pinning are performed under anesthesia in operating room by an experienced attending pediatric orthopedic surgeon within 7 days from the injury. Pin fixation is performed with two 1.6 mm pins. Padded dorsal above elbow and volar below elbow splints are applied. Splints and pins are removed at the outpatient clinic at 4 weeks after surgery.
Procedure: Percutaneus pinning
Reduction under fluoroscopic guidance and fixation using two crossing 1.6mm K-wires.
- Wrist ROM [ Time Frame: 6 months ]The ratio (injured side/non-injured side) in total active range of motion of the wrist in the flexion-extension plane.
- Forearm ROM [ Time Frame: 6 months ]The ratio (injured side/non-injured side) in the total active forearm rotation.
- Patient-reported pain [ Time Frame: 1 and 4 weeks, 3 and 6 months, 1 year ]Pain at rest and in activities is assessed on PedsQL questionnaire. Range 0 to 100 mm, 0 best.
- Patient-reported outcome (PROM) [ Time Frame: 4 weeks, 3 and 6 months, 1 year ]Quick-DASH, range 0 to 100, 0 best
- Radiographic outcomes [ Time Frame: 1 and 4 weeks, 3 and 6 months, 1 year ]Sagittal and coronal plain radiographs
- Grip strength [ Time Frame: 3 and 6 months, 1 year ]Objective grip strength measurement using dynamometer
- Forearms length [ Time Frame: 3 and 6 months, 1 year ]Length of forearms and hands
- Wrist ROM [ Time Frame: 3 months, 1 year ]The ratio (injured side/non-injured side) in total active range of motion of the wrist in the flexion-extension plane.
- Forearm ROM [ Time Frame: 3 months, 1 year ]The ratio (injured side/non-injured side) in the total active forearm rotation.
- Overall satisfaction [ Time Frame: 6 months ]The patient's parent(s) or guardian(s) are queried about their satisfaction with the treatment. The satisfaction of the function of the fractured upper extremity and its effect on the patient's daily living and satisfaction to the cosmetic outcome are recorded on a 5-step Likert scale.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04323410
|Contact: Topi Laaksonen, MD||+358 50 427 email@example.com|
|New Children's Hospital||Recruiting|
|Contact: Topi Laaksonen, MD +358 50 427 1654 firstname.lastname@example.org|