REPAIR OF 5 DISTAL RADIUS FRACTURES WITH AN INVESTIGATIONAL CANCELLOUS BONE-CEMENT - A PRELIMINARY-REPORT

Objective: The purpose of the study was to evaluate the feasibility of Norian SRS bone cement injected percutaneously into a distal radius f ollowing reduction in both preventing loss of reduction as well as saf ety. Design: The study was a prospective clinical study with an establ ished protocol. Setting: The study was conducted al the Massachusetts General Hospital following approval of the institutions Investigationa l Review Board. All patients were required to read and approve an info rmed consent document. Patients: While twenty patients' radiographs fu lfilled the requirement of a dorsally displaced extraarticular fractur e to have occurred within 72 hours of presentation, only five consente d 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 s ystem into the metaphyseal defect of the fracture. A short arm cast wa s applied and remained in place for six weeks. Main Outcome Measuremen ts: Radiographic parameters of fracture reduction were measured prospe ctively by an independent radiologist throughout the 12 months of the study. Clinical parameters of hand and wrist function were measured pr ospectively by an independent occupational therapist. Results: At 12-m onth follow-up, radial length was a mean 9.9 mm with an average loss o f < 1mm; radial angle maintained at a mean 25.4 degrees; volar angle w as 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 reac hed a mean of 88 percent of the contralateral side. Dorsal and volar e xtrusion of injected Norian SRS in 4 patients resorbed over time. Ther e were no clinically significant adverse effects or complications. Con clusions: Norian SRS proved to be clinically safe and effective as a c ancellous bone cement to maintain fracture reduction of unstable extra articular distal radius fractures.