Overriding distal forearm fractures are typically treated with reduction and percutaneous pinning. However, conservative treatment seems to have equal clinical results.
This is a randomised controlled trial comparing outcomes between percutaneous pin fixation and cast immobilisation without reduction.
Full Title of Study: “Percutaneus Pinning Versus Cast-immobilisation With a Finger Trap Method in Treatment of Pediatric Overriding Distal Forearm Fractures – Randomised Controlled Trial”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Single (Outcomes Assessor)
- Study Primary Completion Date: March 31, 2023
Overriding fractures have been managed with anatomical reduction performed under anaesthesia with or without percutaneous pinning. This research protocol was developed due to good results reported on leaving the fractures in an overriding position.
On this randomised controlled trial we will compare objective outcomes between anatomic reduction and percutaneous pin fixation together with finger trap traction and cast immobilisation.
Inclusion criteria are patients younger than 11 years old (Tanner 0) with completely overriding distal radius fractures. At the emergency department patients are randomised into two groups: anatomic reduction and percutaneous pin fixation (control group) or finger trap traction and cast immobilisation (experimental 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 surgical treatment with percutaneous pinning and conservative treatment with finger trap method for completely displaced distal radius fractures. Our null hypothesis is that there are no radiological or clinically relevant differences in outcome measures between the two treatment groups. We expect operative treatment to result in earlier radiological recovery and more satisfied patients than non-operative treatment at 6 weeks, but we expect the differences to be clinically and statistically insignificant at 6 months.
- Procedure: Cast immobilisation
- Cast immobilisation is done using finger trap traction. The fractured forearm is splinted above elbow with dorsal cast without attempted reduction.
- Procedure: Percutaneus pinning
- Reduction under fluoroscopic guidance and fixation using two crossing K-wires.
Arms, Groups and Cohorts
- Experimental: Cast immobilisation
- The Finger trap traction is performed without procedural anesthesia, instead non-steroid anti-inflammatory and analgesics are given to the patient, giving the possibility of an early discharge. In the finger trap traction group patients are placed in the traction without additional weights, followed by dorsal above elbow fiberglass splint with volar forearm splint, and the fracture is left to an overriding position. 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).
- Active Comparator: Percutaneus pinning
- Surgical treatment will be performed either by or under the supervision of an experienced orthopedic surgeon within 2 weeks after initial trauma by closed reduction and percutaneous pinning with two K-wires under anesthesia. A dorsal above elbow fiberglass splint with volar forearm splint is applied after the procedure. If palpated tenderness is still present, the patient is given a dorsal forearm splint which can be removed (maximum of 2 weeks usage).
Clinical Trial Outcome Measures
- Range of motion
- Time Frame: 6-month
- The range of motion of wrist and forearm
- Patient-reported pain
- Time Frame: 6-months
- Patient-reported outcome (PROM)
- Time Frame: 6-months
- Radiographic outcome
- Time Frame: 6-months
- Sagittal and coronal plain radiographs
Participating in This Clinical Trial
- Child with open epiphysis with closed overriding metaphyseal distal radial fracture with or without an associated fracture of the ulna (AO 23-M/3.1)
- Availability for at least 1-year of follow-up after surgery
- Gustillo II and III open fractures.
- Absence of any other underlying disease that could affect bone union.
- Other bony injury or joint upper extremity dislocation (including Galeazzi fracture) or visceral injury in other parts of the body.
- Nerve or vascular injury.
- Ability to communicate on age level.
- Normal communication development (languages Finnish, Swedish, English).
Gender Eligibility: All
Minimum Age: N/A
Maximum Age: 11 Years
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Töölö Hospital
- Provider of Information About this Clinical Study
- Principal Investigator: Topi Laaksonen, Surgeon – Töölö Hospital
- Overall Contact(s)
- Topi Laaksonen, MD, +358 50 427 1654, firstname.lastname@example.org
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