FDA Approves New Total Ankle Replacement System

NewsBot · May 28, 2009

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Press Release:
FDA Approves New Total Ankle Replacement System

The U.S. Food and Drug Administration today approved a total ankle replacement system for arthritic or deformed ankles that may preserve some range of motion in the joint.

The new prosthesis is a mobile-bearing device, which relies on bearings that move across a surface of polyethylene, a flexible plastic. The device is the first of its type.

Once arthritis or injury destroys the cartilage that cushions the ankle bone, the joints can become painful enough to warrant total ankle replacement.

The Scandinavian Total Ankle Replacement (STAR) System is an alternative to fusion surgery and may allow for greater rotation and movement in the joint. Fusion surgery involves cementing the shin bone (tibia) – the thicker of the two bones in the lower leg – to the talus bone in the ankle. The procedure stabilizes the ankle, but significantly decreases the ability to move the foot up and down.

“This device offers another treatment alternative to fusion surgery, and more closely imitates the function of a natural ankle,” said Daniel G. Schultz, M.D., director of the FDA’s Center for Devices and Radiological Health. “For the first time in the United States, a patient may retain some ankle mobility with this non-constrained, mobile-bearing device.”

The FDA has already cleared several fixed-bearing ankle devices, which are also options to fusion surgery. In fixed-bearing ankle system, the articulating surface is molded, locked or attached to one of its metallic components.

For two years, researchers followed a subgroup of a 224-patient clinical study and found that the STAR system demonstrated similar rates of adverse events, surgical interventions and major complications as fusion surgery.

As a condition of FDA approval, the company will evaluate the safety and effectiveness of the device during the next eight years.

The STAR Ankle is owned by Small Bone Innovations Inc. of Morrisville, Pa.
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NewsBot · Aug 27, 2011

Revision Total Ankle Replacement: An Early Look at Agility to INBONE.
Devries JG, Berlet GC, Lee TH, Hyer CF, Deorio JK.
Foot Ankle Spec. 2011 Aug;4(4):235-244.

Introduction. The role of total ankle replacement (TAR) is expanding in the United States. As the number of ankles implanted increases, undoubtedly the number of failures will increase. Several reports in the literature have dealt with salvage of the failed TAR through various methods.

Methods. A retrospective chart and radiographic review was performed on all patients who had conversion from a failed Agility TAR to an INBONE TAR at 2 centers and had been performed at least 12 months prior to the study. Exclusion criteria included any patient converted from a different type of TAR, primary TAR, patients followed less than 12 months, and surgical approach other than the standard anterior incision.

Results. Five patients met inclusion criteria. The average age was 65.6 ± 13.6 years (range = 45-79 years). Complicating comorbidities were found with 4 patients. The average follow-up was 17.2 ± 6.6 months (range = 7-25 months). The cause of failure of the original Agility TAR was coronal plane deformity in 3 patients, and 1 patient each failed from extensive heterotopic ossification or infection. All patients presented with pain. In 4 cases, there was component subsidence at the talus, tibia, or both. All patients had adjunctive procedures at the time of the revision, including malleolar screw placement in 4 patients and hindfoot arthrodesis in 2 patients. All patients had either 4 or 5 tibial stem components placed. During the follow-up period, 3 patients required additional surgery, including 2 patients classified as failures (1 transtibial amputation and 1 tibiotalocalcaneal arthrodesis).

Discussion. This salvage option is technically demanding. The authors caution against TAR revision by conversion in the place of previous infection and in ankle imbalance not amenable to reconstruction. In all cases the initial deformity was corrected. The early results, however, demonstrate high risk of early failure and positional changes.
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