The U.S. Food and Drug Administration (FDA) has approved SBi’s Scandinavian Total Ankle Replacement (STAR™ Ankle) system to treat U.S. patients. It is a safe, proven alternative to failed conservative treatment. It is the only three piece mobile bearing non constrained, uncemented total ankle replacement (to receive pre-market approval to replace a painful arthritic ankle joint due to post traumatic arthritis or rheumatoid arthritis). The instructions for use and patient labeling issued by the FDA indicates the STAR™ Ankle patients had superior effectiveness compared to ankle fusion and had comparable safety results to ankle fusion in the clinical trial.
A U.S. Investigational Device Exemption (IDE)
Clinical Trial of STAR™ Ankle was initiated in August,
2000 as a prospective, multi-center controlled pivotal study to
compare the safety and efficacy of STAR™ Ankle to
ankle fusion (the current standard of care). More than 670 patients
were enrolled in the pivotal and continued access phases of the
IDE clinical trials. The instructions for use and patient labeling
issued by the FDA indicates that the STAR™ patients
had superior effectiveness compared to ankle fusion and had comparable
safety results to ankle fusion in the clinical trial.
The STAR™ Ankle has more than 19 years of clinical experience and the current design has been implanted in over 15,200 patients worldwide. Additionally, there have been 35 peer-reviewed clinical outcome papers published on the STAR™ Ankle. SBi believes that this number of papers is more than any other mobile-bearing total ankle arthroplasty device.
Currently, there are a few 510(k) ankle replacement devices cleared for U.S. marketing as an alternative to fusion. All of these ankle replacements are fixed-bearing devices that limit motion and are indicated for use with bone cement.
STAR™ is the only FDA-approved total ankle replacement system for uncemented use, which allows for better bone in-growth, stabilization and bone preservation.
The SBi STAR™ Ankle prosthesis consists of three components:
1. A tibial component with a highly polished flat articulation surface and two cylindrical fixation bars on the proximal side of tibia to anchor the implant in the subchondral bone of the tibia. Five sizes are available.
2. A talar component, also available in five different sizes for right and left. A ridge running anteroposteriorly in the middle of the gliding surface guides the ultra high molecular weight polyethylene (UHMWPE) mobile bearing sliding core.
3. The mobile bearing is an UHMWPE sliding core, the flat surface of which articulates with the tibial component while the concave shaped underside articulates with the convex shaped talar component. The anteroposterior articulation is guided by the longitudinal ridge on the talar component and the matching longitudinal groove in the underside of the mobile bearing sliding core. Mobile bearing sliding cores are available in five heights: 6, 7, 8, 9, and 10 mm.
A porous plasma spray is applied to the STAR™ Ankle. The instrument set for implantation of the prosthesis consists of drill and saw guides, trial prostheses, and auxiliary instruments that allow precise, reproducible bone resection. The minimal resection required by the STAR™ Ankle prosthesis means that excessive bone loss is avoided. Precise Guidance Technology (PGT™) allows surgeons to perform total ankle arthroplasty with consistent and predictable outcomes. The PGT™ instrumentation provides a complete solution for total ankle arthroplasty.
Moderate to severe pain or loss of mobility/function due to:
- Post traumatic arthritis
- Primary ankle arthritis
- Rheumatoid arthritis
Painful ankles and ankles with degenerative conditions but with sufficient stability are also indications for use of the STAR™ Ankle prosthesis.
Please e-mail firstname.lastname@example.org for those interested in receiving information about the STAR™ Ankle as patients or surgeons interested in training.
MKT 16080 Rev. A