Innovative Soft Tissue Fixation System Offers Versatility For Surgeons

Could an alternative fixation options for digital deformities facilitate a personalized and versatile approach to each case? The design of the Paragon 28® TenoTac® Soft Tissue Fixation System aims to replace a traditional flexor tendon transfer for flexible hammertoes or supplement fixation of rigid hammertoes and plantar plate repair by providing stabilization of the metatarsophalangeal joint in both the sagittal and transverse planes.

The TenoTac system allows surgeons to address flexible and semi-rigid hammertoe deformities, plantar plate insufficiency, MPJ instability, as well as other foot and ankle applications with minimal steps, says the manufacturer. They continue to say that the system is designed for execution of a single, reproducible technique to address a multitude of patient-specific pathologies. It features cannulated instrumentation that facilitates a two-handed approach to correction, temporary fixation and final implant placement. The implant itself consists of a threaded male tack with a single row of gripping spikes and a female sleeve with a low-profile head. The male tack comes in standard and large (hallux) sizes, and the female sleeve in four sizes. According to Paragon 28, The TenoTac Soft Tissue Fixation System comes in either a sterile packaged kit or a non-sterile caddy, both with all necessary instrumentation and implant sizes.

The company shares that surgeons may include or isolate the flexor digitorum brevis or flexor digitorum longus to accommodate correction of individual deformities. A larger system is also available for hallux malleus deformities, so that surgeons may tack down the flexor hallucis longus tendon. It is also possible to adjust tension on specific tendons to customize correction when needed. Examples of applications include: as a replacement for a Girdlestone-Taylor procedure for flexible hammertoes; MPJ stabilization as part of a proximal interphalangeal joint arthroplasty or arthrodesis; digital deformity correction when combined with plantar plate repair; and correction of flexible claw toe or mallet toe.

Douglas K. Blacklidge, DPM, FACFAS has used the TenoTac Soft Tissue Fixation System since its launch in early 2019, primarily for repair of flexible toe contractures, and especially for contracted toes associated with plantar plate insufficiency or tears. He says he feels the system is especially unique in that it creates a new insertion for the flexor tendon at the base of the proximal phalanx, which is the goal of a flexor tendon transfer.

“It simplifies tendon re-routing around the phalanx or through a drill hole,” says Dr. Blacklidge, in practice in Kokomo and Lafayette, Indiana.

Karl Dunn, DPM, FACFAS also relates over two-and-a-half years of experience with the TenoTac Soft Tissue Fixation System, sharing good success utilizing the system on an array of different hammertoe cases, including both primary and revision-type cases.

“This system really stands apart from the existing hammertoe systems on the market,” he says. “The TenoTac allows for a tendon re-balancing, which can be a very powerful procedure.”

Dr. Dunn, in practice in East Lansing, Michigan, feels that one of the key features of the system is the ability to dial in the proper correction based on the patient’s deformity. “After I load the foot, I am able to re-assess the toe position, and without burning a bridge, keep the proper position or alter the device, if needed,” he explains.

Dr. Blacklidge adds that the TenoTac device compresses the flexor tendon directly into a new insertion site at the base of the proximal phalanx, providing stability and reinforcement for the metatarsophalangeal joint and plantar plate while correcting interphalangeal joint contractures.

“I find that his device is ideal for the correction of a contracted toe with or without a metatarsophalangeal joint instability,” says Dr. Blacklidge, who is a consultant for Paragon 28 and shares in royalties associated with the device. “The TenoTac is particularly helpful in using the flexor tendon to reinforce a failed plantar plate.”

Dr. Dunn, who is a speaking consultant for Paragon 28, recalls a particular scenario when the TenoTac Soft Tissue Fixation system made a difference.

“I remember an instance in my office where a patient returned for their first postop appointment,” he says. “The patient was practically flabbergasted with excitement based on their toe position, yet the pain and swelling was relatively minimal,” he says.