AIHTA - Publications - Search - Allogenic bone screw Shark Screw® in patients with hallux valgus or scaphoid fractures/pseudarthroses

Wolf, S. and Strohmaier, C. (2021): Allogenic bone screw Shark Screw® in patients with hallux valgus or scaphoid fractures/pseudarthroses. Decision Support Document 128.

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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.

In total, 155 citations were identified through the systematic literature search. In addition, the manufacturer submitted 14 new references. 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.

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.

Item Type:Decision Support Document
Keywords:Hallux valgus, pseudarthrosis of the scaphoid bone, scaphoid bone fracture, allogeneic bone screw, Shark Screw®, health care system relevant outcomes
Subjects:QT Physiology > QT 250-275 Leisure Activities. Sports Medicine
W Health professions > W 100-275 Medical, dental and pharmaceutical service plans
WB Practice of medicine > WB 300-962 Therapeutics
WE Musculoskeletal system > WE 168-190 Orthopedics
WE Musculoskeletal system > WE 200-259 Bones
WE Musculoskeletal system > WE 300-400 Joint tissues
WE Musculoskeletal system > WE 800-890 Extremities and podiatry
WO Surgery > WO 500-517 Operative surgical procedures. Techniques
Series Name:Decision Support Document 128
Deposited on:15 Jul 2021 07:28
Last Modified:15 Jul 2021 07:28

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