Patient Specific Total Talus Replacement
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The restor3d patient specific Total Talus Replacement System is an alternative treatment option to fusion or amputation designed to replace a native talus bone that has been affected by a disease state or injury. The system consists of a 3D printed Cobalt Chromium alloy implant and single-use disposable instrumentation including size trials and impactors to assist in surgical placement of the implant. The data driven design of the implant enables the patient to maintain ankle range of motion, reduce pain and improve physical function.
Overview
Product Highlights
- A novel, FDA approved device offering an alternative treatment option to fusion or amputation for numerous indications.
- Additively manufactured, or 3D printed, patient specific implant.
- Three optional suture attachment sites to enable soft tissue reconstruction, as needed.
- Radiodense, single-use instrumentation for trialing and the implant is made available in multiple sizes to allow intraoperative flexibility.
Who should be treated with a restor3d Total Talus Replacement implant?
The restor3d Total Talus Replacement implant is indicated for:
- avascular necrosis of the talus
- avascular necrosis of the talus in addition to talar collapse, cysts or non-union
- large, uncontained, unstable, or cystic talar osteochondral defects with risk of collapse or talar osteochondral defects not responsive to traditional treatments
- non-union following talar fracture or talar extrusion, unresponsive to more conservative treatments
The implant is patient specific and is designed from computed tomography (CT) scan. The anatomical landmarks necessary for the design and creation of the restor3d total talus replacement implant must be present and identifiable on CT scan. In addition to reading the information provided in this guide, please talk with your doctor. Your doctor will help you to understand the benefits and risks associated with the procedure and determine if you are a candidate for a Total Talus Replacement implant.
Patient Specific Process
Diagnostics
r3id Case Creation
Pre-Operative Planning
Manufacturing
Surgery
Recovery
Clinical Data
restor3d’s RECLAIM study retrospectively analyzed data from 27 patients enrolled across four sites to demonstrate the safetyand probable benefit of the Total Talus Replacement implant.
Safety Summary
- No (0, 0%) surgical interventions were attributed to the subject device and only two patients (2/27, 7.41%) reported subsequent surgical interventions that were potentially attributed to the procedure.
- No (0, 0%) adverse events were attributed to the subject device.
- Importantly, 26 (26/27, 96.3%) participants retained their devices, suggesting strong implant survivorship.
- No (0, 0%) patients reportedly received a below the knee amputation and all patients were successfully able to salvage their limbs.
Probable Benefit Summary
The patients who were treated with the restor3d Total Talus Replacement implant in the above study received a clinically meaningful probable benefit from the device for several reasons. Across the enrolled participants, not only did the restor3d Total Talus Replacement implant prevent below the knee amputation, but it also improved the quality of life for many patients through reduced pain, maintained range of motion and improved physical functioning. These positive impacts afford patients the ability to return to work, maintain a healthy lifestyle through physical activity, and engage with friends and family.
These positive impacts afford patients the ability to return to work, maintain a healthy lifestyle through physical activity, and engage with friends and family.
Patients reported an improvement in perceived pain from baseline to last follow-up on both Pain NRS and PROMIS-Pain Interference measurement tools.
PROMIS-Pain Interference is a measure utilizing computerized adaptive testing to better assess the impact of an individual’s pain on physical, mental, and social functioning. A T-score of 50 points represents the United States general population mean with a standard deviation of 10 points. Higher T-scores indicate pain having a larger impact on an individual’s life. The study team defineda minimally important difference perceived as beneficial to be a2.5-point reduction in T-scores from baseline to last follow-up on thePROMIS-Pain Interference scale. Across all cohorts, patients had a 5.00-pointmean improvement in T-scores from baseline to last follow-up, demonstrating ameaningful improvement in pain. Similar to the PROMIS-PainInterference measure, the general population mean on the PROMIS-PhysicalFunction measure is a T-score of 50 points (SD = 10). On the PROMIS-PhysicalFunction measure, higher scores indicate that an individual has better physicalfunction. Across all patients, patients had a 3.00-point mean improvement inT-scores from baseline to last follow-up, demonstrating a meaningfulimprovement in physical function.
Figure 1
Pain NRS - baseline and last follow-up by duration of follow-up. Bars represent standard deviations
Figure 2
PROMIS Pain Interference - mean baseline and last follow-up scores by duration of follow-up.
Patients demonstrated improved physical function as more postoperative time elapsed. Importantly, patients who had more than 1 year of follow-up reported a 6-point improvement in PROMIS-Physical Function T-scores, nearly reaching normal limits of the scale.
Figure 3
PROMIS - Physical Function scores by Follow-Up Duration
By the 1-year postoperative time point, both plantarflexion and dorsiflexion returned to baseline.
Figure 4
Degrees of plantarflexion by follow-up duration.
Figure 5
Degrees of dorsoflexion by follow-up duration.
restor3d will initiate a prospectiveclinical study (PROCLAIM) to evaluate the continued safety and probable benefitof the restor3d Total Talus replacement device in commercial use. This will bea multicenter, single arm, prospective, post-approval study of 50 patientsacross up to five clinical sites. Patients will be followed for 5 yearsfollowing surgery for their TTR device. For more information, visit: https://clinicaltrials.gov/study/NCT06311331?cond=talus&term=restor3d&rank=1
Please refer to the IFU for complete Clinical Data information.
