Allogenic bone screw Shark Screw® in patients with hallux valgus or scaphoid fractures/pseudarthroses: systematic review

Wolf S, Strohmaier C
Record ID 32018001658
Authors' objectives: Hallux valgus is one of the most common foot deformities globally, with prevalence rates ranging from 23-36%. Concerning the hand, a scaphoid fracture is the most common carpal fracture globally accounting for 50-80% of all carpal fractures. Untreated or wrongly treated fractures can cause pseudarthroses. All three diagnoses not only cause a burden to the patients but also have societal implications (e.g. societal costs such as productivity losses). This systematic review aimed to analyse whether the allogeneic bone screw Shark Screw® is more effective and equally safe compared to metallic or bioabsorbable bone screws concerning economically relevant endpoints from a health care system perspective.
Authors' results and conclusions: Out of the overall 169 references, no controlled studies, prospective single-arm studies or health economic evaluations met the predefined inclusion criteria. An additional search in three clinical trial registries yielded two ongoing prospective single-arm studies assessing the clinical effectiveness of Shark Screw® for a one-year follow-up period.
Authors' recomendations: To date, there is no published evidence to prove that the allogeneic Shark Screw® transplant is more effective and equally safe than other bone screws. Therefore, we currently do not recommend the inclusion of the procedure in the Austrian hospital benefit catalogue. A re-evaluation is recommended in 2025 at the earliest, as the clinical trials search did not identify any ongoing controlled studies.
Authors' methods: In total, 155 citations were identified through the systematic literature search. In addition, the manufacturer submitted 14 new references.
Project Status: Completed
Year Published: 2021
URL for additional information:
English language abstract: An English language summary is available
Publication Type: Full HTA
Country: Austria
MeSH Terms
  • Hallux Valgus
  • Bone Screws
  • Surgical Procedures, Operative
  • Allogeneic Cells
  • Pseudarthrosis
  • Scaphoid Bone
  • Fractures, Bone
  • Hallux valgus
  • pseudarthrosis of the scaphoid bone
  • scaphoid bone fracture
  • allogeneic bone screw
  • Shark Screw®
  • health care system relevant outcomes
Organisation Name: Austrian Institute for Health Technology Assessment
Contact Address: Garnisongasse 7/20, A-1090 Vienna, Austria
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Copyright: HTA Austria - AIHTA GmbH
This is a bibliographic record of a published health technology assessment from a member of INAHTA or other HTA producer. No evaluation of the quality of this assessment has been made for the HTA database.