Juhana Leppilahti, Mari Kuoppala, Timo Sirola, Lukasz Kolodziej, Katri Ahonen, Mikko Aulamo, Jaakko Niinimäki, Pekka Jalovaara
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引用次数: 0
Abstract
Purpose: The purpose of this prospective, multi-centre study was to assess the performance and safety of a combination of osteoconductive β-tricalcium phosphate and osteoinductive native bone proteins (β-TCP - NBP) used as alternative for autograft in ankle and hindfoot arthrodesis.
Methods: Thirty-four patients enrolled underwent ankle or hindfoot arthrodesis with β-TCP - NBP and were evaluated radiographically, clinically, and functionally up to fifty-two weeks. The primary performance endpoint was fusion rate evaluated with CT at six months. Safety was assessed based on the severity and incidence of adverse events. Functional evaluation was performed using the American Orthopaedic Foot & Ankle Society (AOFAS) ankle-hindfoot score and pain was recorded using the Visual Analogue Scale (VAS).
Results: CT at 6 months showed that 85.3% had osseous bridging of the joint of ≥ 25%, 52.9% ≥50%, 8.8% <25% and 5.9% showed no bridging. The AOFAS score increased significantly from 60.4 ± 17.6 points at operation to 68.6 ± 17.2 points at six months and to 73.5 ± 17.7 points at 12 months. The group with fusion rate ≥25% showed significantly higher AOFAS score than that with fusion rate < 25% at 12 months. The mean VAS pain score at rest and during weight bearing decreased significantly (p < 0.0001) from operation to six and 12 months.
Conclusion: This study demonstrated that β-TCP - NBP is a valuable bone graft substitute for fusion of ankle and hindfoot due to debilitating osteoarthritis and offers an alternative for autograft.
期刊介绍：
International Orthopaedics, the Official Journal of the Société Internationale de Chirurgie Orthopédique et de Traumatologie (SICOT) , publishes original papers from all over the world. The articles deal with clinical orthopaedic surgery or basic research directly connected with orthopaedic surgery. International Orthopaedics will also link all the members of SICOT by means of an insert that will be concerned with SICOT matters.
Finally, it is expected that news and information regarding all aspects of orthopaedic surgery, including meetings, panels, instructional courses, etc. will be brought to the attention of the readers.
Manuscripts submitted for publication must contain a statement to the effect that all human studies have been approved by the appropriate ethics committee and have therefore been performed in accordance with the ethical standards laid down in the 1964 Declaration of Helsinki. It should also be stated clearly in the text that all persons gave their informed consent prior to their inclusion in the study. Details that might disclose the identity of the subjects under study should be omitted.
Reports of animal experiments must state that the "Principles of laboratory animal care" (NIH publication No. 85-23, revised 1985) were followed, as well as specific national laws (e.g. the current version of the German Law on the Protection of Animals) where applicable.
The editors reserve the right to reject manuscripts that do not comply with the above-mentioned requirements. The author will be held responsible for false statements or for failure to fulfil the above-mentioned requirements.
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