Pulsed Electromagnetic Fields in the treatment of fresh scaphoid fractures. A multicenter, prospective, double blind, placebo controlled, randomized trial.

BACKGROUND: The scaphoid bone is the most commonly fractured of the carpal bones. In the Netherlands 90% of all carpal fractures is a fracture of the scaphoid bone. The scaphoid has an essential role in functionality of the wrist, acting as a pivot. Complications in healing can result in poor functional outcome. The scaphoid fracture is a troublesome fracture and failure of treatment can result in avascular necrosis (up to 40%), non-union (5-21%) and early osteo-arthritis (up to 32%) which may seriously impair wrist function. Impaired consolidation of scaphoid fractures results in longer immobilization and more days lost at work with significant psychosocial and financial consequences.Initially Pulsed Electromagnetic Fields was used in the treatment of tibial pseudoarthrosis and non-union. More recently there is evidence that physical forces can also be used in the treatment of fresh fractures, showing accelerated healing by 30% and 71% reduction in nonunion within 12 weeks after initiation of therapy. Until now no double blind randomized, placebo controlled trial has been conducted to investigate the effect of this treatment on the healing of fresh fractures of the scaphoid. METHODS/DESIGN: This is a multi center, prospective, double blind, placebo controlled, randomized trial. Study population consists of all patients with unilateral acute scaphoid fracture. Pregnant women, patients having a life supporting implanted electronic device, patients with additional fractures of wrist, carpal or metacarpal bones and pre-existing impairment in wrist function are excluded. The scaphoid fracture is diagnosed by a combination of physical and radiographic examination (CT-scanning).Proven scaphoid fractures are treated with cast immobilization and a small Pulsed Electromagnetic Fields bone growth stimulating device placed on the cast. Half of the devices will be disabled at random in the factory.Study parameters are clinical consolidation, radiological consolidation evaluated by CT-scanning, functional status of the wrist, including assessment by means of the patient rated wrist evaluation (PRWE) questionnaire and quality of life using SF-36 health survey questionnaire.Primary endpoint is number of scaphoid unions at six weeks, secondary endpoints are time interval to clinical and radiological consolidation, number of non-unions, functional status at 52 weeks and non-adherence to the treatment protocol. TRIAL REGISTRATION: Netherlands Trial Register (NTR): NTR2064.

Osteosynthesis of distal radius fractures with the Micronail.

INTRODUCTION: The Micronail(®) is a minimally invasive intramedullar titanium locking screw fixation for two-part dislocated extra-articular fractures and average displaced intra-articular fractures. PATIENTS AND METHODS: In a retrospective study we analyzed the outcome of 20 distal radius fractures in 18 patients (17 female, mean age 78 years), which were treated by Micronail(®). Average follow-up time was 4 months. We describe the operative technique. All fractures were classified according to AO guidelines. We studied the radiologic and clinical outcome. RESULTS: According to the AO classification there were 12 A2, 3 A3, 1 B1, and 1 B3 fracture. Three patients had an antebrachii fracture. Mean American Society of Anesthesiologists (ASA) score was 2.4. Eight patients had associated lesions. Average operative time was 58 min. All fractures healed without major loss of alignment. There were two major complications: one patient developed a carpal tunnel syndrome and one device secondary dislocated. With the use of the Micronail(®), we found no infections or complications due to the insertion of the osteosynthesis materials. Patients experienced good to excellent results, on an analogue scale, in function of their wrist from the procedure. All patients had a good range of motion of the operated wrist; the difference between their two wrists was maximal 10° in all directions. CONCLUSION: This intramedullary implant intends to minimize some of the disadvantages of other surgical options in the treatment of distal radius fracture; the Micronail(®) causes less tissue damage and has early load-carrying capacity. This minimally invasive technique seems suitable in selected, two-part dislocated extra-articular and average displaced intra-articular, distal radius fractures.