Objective: The purpose of the study was to evaluate the feasibility of Norian SRS bone cement injected percutaneously into a distal radius following reduction in both preventing loss of reduction as well as safety.
Design: The study was a prospective clinical study with an established protocol.
Setting: The study was conducted at the Massachusetts General Hospital following approval of the institutions Investigational Review Board. All patients were required to read and approve an informed consent document.
Patients: While twenty patients' radiographs fulfilled the requirement of a dorsally displaced extraarticular fracture to have occurred within 72 hours of presentation, only five consented to participate fully and one voluntarily withdrew after a six-month follow-up.
Intervention: All fractures were reduced under regional or general anesthesia, and the Norian SRS was introduced via a catheter system into the metaphyseal defect of the fracture. A short arm cast was applied and remained in place for six weeks.
Main Outcome Measurements: Radiographic parameters of fracture reduction were measured prospectively by an independent radiologist throughout the 12 months of the study. Clinical parameters of hand and wrist function were measured prospectively by an independent occupational therapist.
Results: At 12-month follow-up, radial length was a mean 9.9 mm with an average loss of < 1mm; radial angle maintained at a mean 25.4 degrees; volar angle was within normal range (0-21 degrees) in 4; and 1 patient had a dorsal angle of 7 degrees. Wrist motion improved 50 percent between 6 weeks and 3 months and improved further by 12 months when grip strength reached a mean of 88 percent of the contralateral side. Dorsal and volar extrusion of injected Norian SRS in 4 patients resorbed over time. There were no clinically significant adverse effects or complications.
Conclusions: Norian SRS proved to be clinically safe and effective as a cancellous bone cement to maintain fracture reduction of unstable extraarticular distal radius fractures.