A Better Solution for Patients
Suffering from AVN of the Talus
A Better Solution for Patients Suffering from AVN of the Talus
Now an FDA approved Alternative to Amputation or Fusion
3D Patient Specific Talus Spacer
The Paragon 28 Patient Specific Talus Spacer is an additively manufactured Paragon 28 Patient Specific Talus Implant.
- The FIRST and ONLY Paragon 28 Patient Specific Talus Implant approved by the FDA
- Indicated for Avascular Necrosis of the ankle
- Provides pain relief and preserves motion of the ankle joint
- Alternative to fusion or amputation
- The Paragon 28 Patient Specific Talus Spacer is an additively manufactured, or 3D printed, patient specific implant that is designed and made individually for each patient using CT image data.
- The Paragon 28 Patient Specific Talus Spacer is indicated for avascular necrosis of the ankle joint. The anatomical landmarks necessary for the design and creation of the Paragon 28 Patient Specific Talus Spacer must be present and identifiable on computed tomography (CT) scan.
Total Talus Replacement
The Paragon 28 Patient Specific Talus Spacer is an alternative treatment option to fusion and amputation, and requires talus replacement surgery. During this procedure the native talus bone is removed and replaced with a 3D printed replica. This is considered a joint-sparing procedure, as it allows the patient to maintain motion of his/her ankle joint.
Patients who received an Paragon 28 Patient Specific Talus Spacer in the clinical study showed a reduction in baseline VAS Pain Scores, improvement in ROM, and improvement of functional outcomes based on all FAOS subscales, including pain, symptom, activities of daily living, ability to perform sports and recreational activities, and foot/ankle-related quality of life. Please refer to the IFU for complete Clinical Data information.
Reduction in VAS Pain Scores
Improvement in Quality of Life
Surgical Technique Overview
1. Skin Incision/Exposure
2. Dorsal Closing Wedge Osteotomy
3. Middle Talus Resection
4. Anteromedial Interosseous Talocalcaneal Ligament Release
5. Anterior Talus Resection
6. Posterior Interosseous Talocalcaneal Ligament Release
7. Release of Ligamentous Attachments within the Posterior Process of the Talus
8. Posterior Talus Segment Resection
9. Implant Sizing and Selections
10. Implantation of Patient Specific Talus Spacer
Click here for detailed surgical technique
Click here for detailed instructions for use
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Frequently Asked Questions
The Paragon 28 Patient Specific Talus Spacer is indicated for avascular necrosis of the ankle joint. The anatomical landmarks necessary for the design and creation of the Paragon 28 Patient Specific Talus Spacer must be present and identifiable on computed tomography (CT) scan.
Use of implant greater than 6 months from date of patient’s CT scan.
Degenerative changes in the tibiotalar, subtalar or talonavicular joints.
Presence of an active infection.
Gross deformity in sagittal or coronal planes. More than 15 degrees of varus or valgus deformity in the coronal plane, or more than 50% subluxation anteriorly or posteriorly of the talus in the sagittal plane.
Osteonecrosis of the calcaneus, distal tibia or navicular.
Known history of existing malignancy, or any systemic infection, local infection, or skin compromise at the surgical site.
Blood supply limitations and previous infections that may prevent healing.
Physical conditions that would eliminate adequate implant support or prevent healing, including inadequate soft tissue coverage.
Conditions which may limit the patient’s ability or willingness to restrict activities or follow directions post-operatively during the healing period.
Presence of neurological deficit which would prevent patient post-operative compliance.
Sensitivity or allergy to the metal implant. Where material sensitivity is suspected, appropriate tests should be made, and sensitivity ruled out prior to implantation.
It is mandatory that the user, surgeon and surgery personnel are acquainted with the respective-surgical technique and implants used.
Surgical implants and anatomical models may only be used for surgeries, for which the designated application of the implant is explicitly necessary and defined.
The trained expert staff is obligated to examine the surgical implant and its sterile packaging for damages prior to each application i.e. use. In case of the implant or its packaging being damaged or deformed, it is not to be used.
Correct selection of the implant is extremely important. That patient’s anatomy and indication will determine the size of the implant to be used.
No partial weight-bearing or non-weight bearing device can be expected to withstand the unsupported stresses of full weight-bearing. Until firm bone union is achieved, the patient should employ adequate external support and restrict physical activities which would place stress upon the implant or allow movement of the implant and delay healing.
Postoperative care is extremely important. The patient must be warned that noncompliance with postoperative instructions could lead to breakage of the implant. The risk of device failure may increase due to patient-related factors including activity level, weight, or noncompliance due to psychological condition.
Patient Specific Implants are designed from patient data such as radiograph (X-ray), computed tomography (CT), or magnetic resonance imaging (MRI). Over time, a patient’s anatomy can change. If a significant amount of time has elapsed from the time of collection of the patient data (date of scan) to the time of surgery utilizing a Patient Specific implant, the implant may not fit the patient’s anatomy correctly.
A Unique Implant Solution made possible through the use of Additive Manufacturing.
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