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NCT03965143 · ClinicalTrials.gov registry record
Talus Replacement Registry
A clinical trial of Avascular Necrosis of the Talus, sponsored by Kyle Schweser MD.
- Recruiting
- Registry status
- 50
- Enrollment target
- 1
- Study location
NCT03965143 is a study of Avascular Necrosis of the Talus that is actively recruiting participants, run by Kyle Schweser MD. The registered enrollment target is 50 participants. The trial reports 1 study location across 1 state.
The verdict
NCT03965143, a study of Avascular Necrosis of the Talus, is actively recruiting participants, sponsored by Kyle Schweser MD.
- RECRUITING
- Registry status
- 50 participants
- Enrollment target
- 1
- Study location
Study Summary
Avascular necrosis of the talus is a difficult problem to manage, especially in the young and healthy. The only option, historically, has been a talectomy and hindfoot fusion. While this is a viable option, it is not without its morbidity. Arthritis of surrounding joints is common, occurring anywhere from 1-10 years after the procedure. This is especially true in younger patients, where loss of motion can be life altering both physically and mentally. The search for alternatives has been limited. Recently, 3D printing has become more ubiquitous and affordable and newer medical alternatives have arisen thanks to this technology. The 3D custom talus is relatively new in the orthopaedic community, but has been used at several centers with good success. It has been shown to re-establish the normal alignment of the foot, preserve motion (with some achieving almost physiologic motion), and allow for almost normal ambulation. However, the data is still limited and further study is necessary. Our facility was recently approved to perform this procedure. Our hypothesis is that custom 3D printed talar body replacements, either used alone or with total ankle replacements, will maintain physiologic motion, have no difference in complications when compared to hindfoot fusions with allograft, lead to good outcome scores and patient satisfaction scores. Patients diagnosed with avascular necrosis of the talus who have already decided to undergo a procedure involving a 3D custom talus as part of their standard care (talar replacement, total ankle/total talus, etc) will be enrolled in the study. Patients will follow standard post-operative protocols and return to clinic at designated time periods (2 weeks, 6 weeks, 3 months, 6 months, 1 year). X-ray evaluation, Range of motion, return to ambulation, walking speed and patient reported outcomes will be evaluated at each visit. Data will then be compared with baseline measurements and use to determine the progression of patients over ti
Conditions Studied
Interventions
- DEVICE 3D talar augmentation
Study Locations (1)
Missouri
- University of Missouri - Columbia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2020-01-01 |
| Est. Completion | 2026-06-01 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03965143
The ClinicalTrials.gov registry entry for NCT03965143 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Kyle Schweser MD, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Avascular Necrosis of the Talus appearing as the primary indexed condition, and to 1 intervention - of which 3D talar augmentation is the first listed.
NCT03965143 reports 1 study location spanning 1 distinct geographic area - top geographies include Missouri.
Frequently Asked Questions
What is clinical trial NCT03965143 about?
NCT03965143 is a clinical study titled "Talus Replacement Registry". Avascular necrosis of the talus is a difficult problem to manage, especially in the young and healthy. The only option, historically, has been a talectomy and hindfoot fusion. While this is a viable option, it is not without its morbidity. Arthritis of surrounding joints is common, occurring anywher...
What is the current status of trial NCT03965143?
This trial is currently recruiting. The enrollment target is 50 participants. The study started on 2020-01-01. Estimated completion is 2026-06-01.
What conditions does trial NCT03965143 study?
This clinical trial studies the following conditions: Avascular Necrosis of the Talus.
What interventions are being tested in trial NCT03965143?
The interventions under investigation include: 3D talar augmentation (DEVICE).
Who is sponsoring clinical trial NCT03965143?
This trial is sponsored by Kyle Schweser MD, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03965143 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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