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
- Scaffold for tightening and integration of talocalcaneal ligaments
- Improvement in posture
- Early Weightbearing
- No hard stop feeling=better tolerated
- No MRI Restrictions
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Talus Implants* (Int’l Only)
To treat ankle pain in our International Markets, we offer the Talus HemiCAP® which has 10 convexities and a unique geometry. There are often patients who only have damage to the ridge and dome of the talus (usually medially). The common solutions for this type of defect are a fusion or total ankle replacement after conservative treatments have failed. For localized talar lesions, these options might be considered too aggressive, especially in a young patient. Arthrosurface® designed the Talus HemiCAP® to restore the dome, ridge and medial wall with all three curves/surfaces incorporated into one implant.
- One implant for 3 surfaces: dome, ridge and medial wall
- Screw based fixation provides a stable implant
- Inlay components restore congruency & maintain existing biomechanics
- Implant protects subchondral bone and shares load with surrounding tissue
- Minimal bone & tissue removal maintains future options – “No Bridges Burned”
The Talus HemiCAP® implant system is comprised of two parts, an articular cap and a fixation component. The surgical procedure begins with an arthroscopy. If the articular defect is deemed appropriate for the HemiCAP® procedure, then a malleolar osteotomy is performed to access the joint. The axis perpendicular to the lesion is established with the drill guide and a guide wire is introduced into the middle of the defect. The fixation component is implanted to establish the mechanism for anchoring the articular component. The uniquely designed instruments are used to map the contours of the patient’s native surface curvatures using the fixation component as a central axis. The defect is then prepared for the resurfacing implant. Once the proper fit is confirmed using the trial the HemiCAP® implant is brought into position and seated. The osteotomy site is then set in place with screws and the joint is closed.
HemiCAP® technology was designed for patients who have failed a previous surgical treatment but want to continue working while maintaining an active lifestyles.
- May be performed on an outpatient basis
- Allows for preservation of the joint and surrounding bone
- Clinical studies demonstrate early positive clinical outcomes
- Patients experience a rapid return to their everyday activities
- Maintains existing joint biomechanics, thereby allowing normal motion
- A treatment option that bridges the gap between biological therapies and joint replacement
- Patients report pain relief, rapid recovery times and range of motion improvements
- Intuitive, universal, reproducible procedure across multiple joints
- Minimally invasive outpatient procedure can be performed in approximately one hour
- Maintains soft-tissue envelope, native joint mechanics and preserves future options
- Preserves anatomy and bone should a future joint replacement or arthrodesis be required
If you have a patient with disabling talus pain that may need an ankle replacement or fusion, they may be a candidate for Talus HemiCAP® Resurfacing.
The Talus HemiCAP® is approved for patients via CE Mark and other countries outside of the United States. If you would like to learn more about the procedure performed in Europe, please contact:
Clinica Espregueira Mendes
Entrada Nascente 4350-415 Porto
Telephone: +351 220 100 100