Christian Ryf1, Sabine Goldhahn2,3, Marek Radziejowski4, Michael Blauth5, Beate Hanson6. 1. Davos Hospital, Davos Platz, Switzerland. 2. AO Clinical Investigation and Documentation, Dübendorf, Switzerland. sabine.goldhahn@aofoundation.org. 3. AO Clinical Investigation and Documentation, Stettbachstrasse 6, 8600, Dübendorf, Switzerland. sabine.goldhahn@aofoundation.org. 4. Springs Parklands Clinic, Department of Orthopedics, Wits University Johannesburg, Johannesburg, South Africa. 5. Department for Trauma Surgery and Sports Medicine, Medical University of Innsbruck, Innsbruck, Austria. 6. AO Clinical Investigation and Documentation, Dübendorf, Switzerland.
Abstract
OBJECTIVE: The restoration of metaphyseal defects remains a challenge for the treating surgeon. Although injectable brushite cements may help to refill bone defects stabilized with internal fixation, human data remains unavailable. The main goal of this prospective multicenter study was to observe the performance of this material in a clinical setting. PATIENTS AND METHODS: The study conducted in seven trauma units included closed metaphyseal distal radius and proximal tibia fractures with bone defects, stabilized with internal fixation and subsequent filling with brushite cement. At 6- and 12-month follow-ups, patient satisfaction (visual analog scale [VAS]) was recorded, as well as complications. RESULTS: Thirty-eight proximal tibia fractures and 37 patients with distal radius fractures were included. Overall patient satisfaction with the treatment was high (mean VAS = 92 and 91 for proximal tibia and distal radius, respectively), despite the loss of reduction being described in 11% of proximal tibia and 24% of distal radius fractures; the majority of them included severe fracture types. Radiological evaluation showed postoperative cement leakage in 20 cases, where the majority occurred at the distal radius (n = 15). In 13 distal radius fractures, the leakage was resorbed by the final examination. CONCLUSION: The tested material showed good outcome in the majority of patients and adequate resorption characteristics, even in the case of extravasation. Stable internal fixation, sufficient bone quality, and no contact between the cement and joint are essential requirements for chronOS Inject, which can be considered as an alternative to existing augmentation materials.
OBJECTIVE: The restoration of metaphyseal defects remains a challenge for the treating surgeon. Although injectable brushite cements may help to refill bone defects stabilized with internal fixation, human data remains unavailable. The main goal of this prospective multicenter study was to observe the performance of this material in a clinical setting. PATIENTS AND METHODS: The study conducted in seven trauma units included closed metaphyseal distal radius and proximal tibia fractures with bone defects, stabilized with internal fixation and subsequent filling with brushite cement. At 6- and 12-month follow-ups, patient satisfaction (visual analog scale [VAS]) was recorded, as well as complications. RESULTS: Thirty-eight proximal tibia fractures and 37 patients with distal radius fractures were included. Overall patient satisfaction with the treatment was high (mean VAS = 92 and 91 for proximal tibia and distal radius, respectively), despite the loss of reduction being described in 11% of proximal tibia and 24% of distal radius fractures; the majority of them included severe fracture types. Radiological evaluation showed postoperative cement leakage in 20 cases, where the majority occurred at the distal radius (n = 15). In 13 distal radius fractures, the leakage was resorbed by the final examination. CONCLUSION: The tested material showed good outcome in the majority of patients and adequate resorption characteristics, even in the case of extravasation. Stable internal fixation, sufficient bone quality, and no contact between the cement and joint are essential requirements for chronOS Inject, which can be considered as an alternative to existing augmentation materials.
Entities:
Keywords:
Bone cement; Bone substitutes; Radius fractures; Tibial fractures
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