Test ankle.

SpiralUp TCL Allograft

Talocalcaneal instability and peritalar subluxation are progressive conditions with far-reaching symptoms in a vast patient population. The SpiralUP™ TCL Allograft System is an acellular dermal allograft intended to supplement the talocalcaneal ligament and as such, function as a dense, stable and spongey connective tissue layer. It is intended to improve function of the foot as well as conditions along the musculoskeletal (MSK) chain. Talocalcaneal instability and peritalar subluxation can present in many different types of patients from the pediatric population all the way to the geriatric population. It occurs when the sinus tarsi collapses, causing the foot and ankle to roll inward, putting unnecessary strain on the body’s lower extremities. The condition usually presents as:
  • Arch and heel pain
  • Posterior tibial disfunction
  • Tarsal tunnel syndrome
  • Leg, Hip, Knee, Lower Back Discomfort
  • Poor posture
The SpiralUp™ TCL Allograft System is an entirely new approach to treating talocalcaneal instability and peritalar subluxation. While existing procedures have reported causing patients continued discomfort, the SpiralUp™ TCL Allograft should address complications seen with current procedures (i.e. pain, discomfort, implant backing out). The allograft is bullet shaped to support the anatomy of the canal and is engineered from acellular dermal tissue, thus more native to the body. It not only provides the necessary space in the sinus canal, it addresses the ligamentous instability and peritalar subluxation. The SpiralUp is longer and more functional than traditional metal implants and because it is inserted across 80-90% of the sinus tarsi it is able to stabilize the 3 facets (anterior, middle and posterior) of the subtalar joint more effectively than existing metal implants.
  • Pre-rolled, decellularized, freeze-dried, gamma sterilized human dermal allograft tissue
  • 3 Diameters: 7mm, 9mm & 11mm each at 20mm in length
  • Cannulated system
  • Bullet Shaped to support the anatomy of the tarsal canal
  • Sterile, Single-Use Delivery Instruments
    • Ease of implantation
    • Ease of removal
    • No MRI Restrictions
    • Extra articular
    • Reversible
    • Scaffold for tightening and integration of talocalcaneal ligaments
    • Improvement in posture
    • Early Weightbearing
    • No hard stop feeling=better tolerated
    • No MRI Restrictions
    1. Exposure: Create an incision (2-3 cm) along the relaxed skin tension lines slightly proximal to the anterior process of the calcaneus and over the center of the sinus tarsi. Taking care to protect the underlying neurovascular structures, perform blunt dissection of the subcutaneous soft tissues using curved scissors or hemostat to separate the fibers. Remove fibro-fatty plug to gain entry into the sinus tarsi. Using a rongeur or rasp, gently abrade the sinus tarsi margin and adjacent ligaments to facilitate SpiralUp™ TCL Allograft adhesion.
    2. Guide Pin: Insert the 1.3 mm Guide Pin into the sinus tarsi in a lateral-distal to a medial-proximal orientation until tenting of the skin is observed on the medial aspect of the foot. Take care to ensure that the posterior tibial tendon is located superior to the skin tent created by the Guide Pin. Do not force Guide Pin through the skin.
    3. Sizing: Insert Sizing Trial over the Guide Pin and into the sinus tarsi. Utilizing x-ray or fluoroscopy, visualize the talar navicular congruity. Select the appropriate diameter of Sizing Trial (7mm, 9mm, 11mm) to maximize talar navicular congruity for desired outcome.
    4. Delivery Cannula: Remove the Sizing Trial, leaving the Guide Pin in place. Insert the Sizing Trial into the Delivery Cannula to facilitate positioning of the Delivery Cannula. Remove the Sizing Trial.
    5. Allograft: Insert the corresponding size of the SpiralUp™ TCL Allograft over the Guide Pin and into the Delivery Cannula. Deliver the SpiralUp™ TCL Allograft using the Sizing Trial to advance the SpiralUp™ TCL Allograft into final position. Note: SpiralUp™ TCL Allograft should not extend past the lateral margin of the calcaneus. Trim SpiralUp™ TCL Allograft if necessary.
    6. Remove all instruments and discard appropriately. Evaluate the foot utilizing x-ray or fluoroscopy to ensure that the talar head is congruous on the navicular with foot loaded. The incision can now be closed with deep sutures combined with a subcutaneous or skin closure based on the surgeon’s preference.