Description

From Which Medical Device

The Scandinavian Total Ankle Replacement (STAR) is a mobile bearing ankle replacement in which the tibial and talar components are manufactured from cobalt chrome with a titanium plasma spray coating. The tibial component is flat on the articulating surface and has two cylindrical fixation bars on the fixation surface. The talar component has a ridge on the bearing surface to guide the gliding surface of the polyethylene component. The mobile bearing is manufactured from ultra-high molecular weight polyethylene with stainless steel marker wires.

The original device had a single layer of hydroxyapatite on its surface, but in 1998 this was changed to a dual-coating.1 Henricson et al report the device is no longer used in Sweden.2

Mann et al reported 91% of 84 implants remained implanted at 9.1 years in a single institution, with osteolytic lesions seen in 13%.3 Another study has reported better function than after fusion of the ankle.4

The device was FDA approved in 2009.5

References

1. Wood PL, Deakin S. Total ankle replacement. The results in 200 ankles. J Bone Joint Surg Br. 2003 Apr;85(3):334-41. 

2. Henricson A, Nilsson JÅ, Carlsson A. 10-year survival of total ankle arthroplasties: a report on 780 cases from the Swedish Ankle Register. Acta Orthop. 2011 Dec;82(6):655-9. Epub 2011 Nov 9.

3. Mann JA, Mann RA, Horton E. STAR™ ankle: long-term results. Foot Ankle Int. 2011 May;32(5):S473-84.

4. Saltzman CL, Mann RA, Ahrens JE, Amendola A, Anderson RB, Berlet GC, Brodsky JW, Chou LB, Clanton TO, Deland JT, Deorio JK, Horton GA, Lee TH, Mann JA, Nunley JA, Thordarson DB, Walling AK, Wapner KL, Coughlin MJ. Prospective controlled trial of STAR total ankle replacement versus ankle fusion: initial results. Foot Ankle Int. 2009 Jul;30(7):579-96.

5. FDA approval news release. 

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