Avascular Necrosis of the Talus3DTalarNCT03965143
Talus Replacement Registry
An observational study of Avascular Necrosis of the Talus, run by Kyle Schweser MD at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Avascular Necrosis of the Talus
- What is being tested?
- 3D talar augmentation
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2020to 1 May 2027
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients over 18 years of age diagnosed with avascular necrosis of the talar body and amenable to treatment with 3D custom augmentation
Who may be able to join
- Subjects age 18 years or above at time of screening
- Condition satisfies requirement for total talus replacement
- Able to consent and participate in the study
- No previous history of septic arthritis involving the hindfoot/midfoot
- Previous ability to ambulate
Who cannot join
- Active infection, sepsis, osteomyelitis or history of septic arthritis involving the hindfoot/midfoot
- Unable to consent or participate in the study secondary to mental status
- Condition does not qualify for a total talus replacement
- Patients who are pregnant or imprisoned
- Planned relocation or unable to return for required follow-up visits
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Missouri
Columbia, Missouri, 65212
Ennio R Esposito, 573-882-7615, eardvb@health.missouri.edu
About this study
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 time after the procedure
Read the detailed description
After patients have undergone a standard of care 3D talar augment procedure they will return to clinic at designated time periods (2 weeks, 6 weeks, 3 months, 6 months, 1 year). X-rays performed as standard of care will be evaluated. Walking speed will be assessed after patient is allowed to bear weight at the same designated time periods reported above. Patients will also answer questions regarding pain (VAS survey), satisfaction (SSQ-8 survey), outcomes utilizing AAOS foot and ankle scores (survey), and self-reported return to unassisted ambulation. Goniometer measurements will be taken in the clinic at all post-operative visits to determine ROM
- Conditions
- Avascular Necrosis of the Talus
- Being tested
- 3D talar augmentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D talar augmentationDevice
Patients with an avascular necrosis of the body if the talar bone will undergo a 3D custom talar augmentation with or without concomitant ankle arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| 3D talar group | Patients that will undergo a 3D custom talar augment Receives: Device: 3D talar augmentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change Range of motion
Measures with a Goniometer and expressed in degrees
Measured: 12 months
Change in VAS pain Score
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."
Measured: 12 months
Change in AAOS foot an ankle score
The AAOS foot and ankle questionnaire is a patient-administrated 25-item survey specifically developed for foot and ankle-related disability. The questionnaire is divided into two scales, the Foot and Ankle Core scale, comprised of 20 questions and the Shoe Comfort Scale with five questions. The questions themselves are distributed among five different categories: Pain (9 items), function (6 items), stiffness and swelling (2 items), giving way (3 items) and shoe comfort (5 items). Answers are then measured on a scale of 1 to 5 or 6, with 1 being the best outcome score.
Measured: 12 months
SSQ-8 satisfaction score
the SSQ-8 (Surgical Satisfaction Score) is a Patient administered 8-item survey designed to asses satisfaction after a surgical procedure. Answers are then measured on a scale of 1 to 5 or 6, with 1 being the best outcome score.
Measured: 12 months
Change in walking speed
Speed will be measured in seconds over a standard distance
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2019
- Study start1 Jan 2020
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Avascular Necrosis of the TalusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Kyle Schweser MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kyle Schweser MD, University of Missouri-Columbia
- Investigators
- Kyle M Schweser, MD, Principal investigator, Assistant Professor Orthopaedic Trauma/Foot and Ankle
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03965143
- Sponsor's protocol ID
- 2014893
- Acronym
- 3DTalar
- Status last verified
- Apr 2026
- First submitted
- 14 May 2019
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The Investigator will maintain all study records according to applicable University regulatory requirement(s). Hard copy records will be retained for at least 7 years after the last clinic follow-up visit at the Missouri Orthopaedic Institute in a locked filing cabinet. Electronic records will be retained for the same amount of time but on secured computers and servers. If the Investigator withdraws from the responsibility of keeping the study records, custody will be transferred to a person willing to accept the responsibility.
Publications
Jehan S, Shakeel M, Bing AJ, Hill SO. The success of tibiotalocalcaneal arthrodesis with intramedullary nailing--a systematic review of the literature. Acta Orthop Belg. 2011 Oct;77(5):644-51.
PubMed 22187841Ketz J, Myerson M, Sanders R. The salvage of complex hindfoot problems with use of a custom talar total ankle prosthesis. J Bone Joint Surg Am. 2012 Jul 3;94(13):1194-200. doi: 10.2106/JBJS.K.00421.
PubMed 22760387Wagener J, Gross CE, Schweizer C, Lang TH, Hintermann B. Custom-made total ankle arthroplasty for the salvage of major talar bone loss. Bone Joint J. 2017 Feb;99-B(2):231-236. doi: 10.1302/0301-620X.99B2.BJJ-2016-0504.R2.
PubMed 28148666Tracey J, Arora D, Gross CE, Parekh SG. Custom 3D-Printed Total Talar Prostheses Restore Normal Joint Anatomy Throughout the Hindfoot. Foot Ankle Spec. 2019 Feb;12(1):39-48. doi: 10.1177/1938640018762567. Epub 2018 Mar 14.
PubMed 29537314
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Talus Replacement Registry
- ClinicalTrials.gov ID
- NCT03965143
- Acronym / sponsor ID
- 3DTalar / 2014893
- Conditions
- Avascular Necrosis of the Talus
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Kyle Schweser MDUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 28 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 time after the procedure
Detailed description
After patients have undergone a standard of care 3D talar augment procedure they will return to clinic at designated time periods (2 weeks, 6 weeks, 3 months, 6 months, 1 year). X-rays performed as standard of care will be evaluated. Walking speed will be assessed after patient is allowed to bear weight at the same designated time periods reported above. Patients will also answer questions regarding pain (VAS survey), satisfaction (SSQ-8 survey), outcomes utilizing AAOS foot and ankle scores (survey), and self-reported return to unassisted ambulation. Goniometer measurements will be taken in the clinic at all post-operative visits to determine ROM
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 3D talar group | – | Device: 3D talar augmentationPatients that will undergo a 3D custom talar augment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients over 18 years of age diagnosed with avascular necrosis of the talar body and amenable to treatment with 3D custom augmentation
Key inclusion criteria (5 listed)
- Subjects age 18 years or above at time of screening
- Condition satisfies requirement for total talus replacement
- Able to consent and participate in the study
- No previous history of septic arthritis involving the hindfoot/midfoot
- Previous ability to ambulate
Key exclusion criteria (5 listed)
- Active infection, sepsis, osteomyelitis or history of septic arthritis involving the hindfoot/midfoot
- Unable to consent or participate in the study secondary to mental status
- Condition does not qualify for a total talus replacement
- Patients who are pregnant or imprisoned
- Planned relocation or unable to return for required follow-up visits
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D talar augmentationPatients with an avascular necrosis of the body if the talar bone will undergo a 3D custom talar augmentation with or without concomitant ankle arthroplasty | Device | 3D talar group |
Primary outcome
Change Range of motion
Time frame: 12 months
Measures with a Goniometer and expressed in degrees
Change in VAS pain Score
Time frame: 12 months
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."
Change in AAOS foot an ankle score
Time frame: 12 months
The AAOS foot and ankle questionnaire is a patient-administrated 25-item survey specifically developed for foot and ankle-related disability. The questionnaire is divided into two scales, the Foot and Ankle Core scale, comprised of 20 questions and the Shoe Comfort Scale with five questions. The questions themselves are distributed among five different categories: Pain (9 items), function (6 items), stiffness and swelling (2 items), giving way (3 items) and shoe comfort (5 items). Answers are then measured on a scale of 1 to 5 or 6, with 1 being the best outcome score.
SSQ-8 satisfaction score
Time frame: 12 months
the SSQ-8 (Surgical Satisfaction Score) is a Patient administered 8-item survey designed to asses satisfaction after a surgical procedure. Answers are then measured on a scale of 1 to 5 or 6, with 1 being the best outcome score.
Change in walking speed
Time frame: 12 months
Speed will be measured in seconds over a standard distance
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Background: PubMed 22187841Jehan S, Shakeel M, Bing AJ, Hill SO. The success of tibiotalocalcaneal arthrodesis with intramedullary nailing--a systematic review of the literature. Acta Orthop Belg. 2011 Oct;77(5):644-51.
- Background: PubMed 22760387Ketz J, Myerson M, Sanders R. The salvage of complex hindfoot problems with use of a custom talar total ankle prosthesis. J Bone Joint Surg Am. 2012 Jul 3;94(13):1194-200. doi: 10.2106/JBJS.K.00421.
- Results publication: PubMed 28148666Wagener J, Gross CE, Schweizer C, Lang TH, Hintermann B. Custom-made total ankle arthroplasty for the salvage of major talar bone loss. Bone Joint J. 2017 Feb;99-B(2):231-236. doi: 10.1302/0301-620X.99B2.BJJ-2016-0504.R2.
- Results publication: PubMed 29537314Tracey J, Arora D, Gross CE, Parekh SG. Custom 3D-Printed Total Talar Prostheses Restore Normal Joint Anatomy Throughout the Hindfoot. Foot Ankle Spec. 2019 Feb;12(1):39-48. doi: 10.1177/1938640018762567. Epub 2018 Mar 14.
- Individual participant dataSharing planned: No. The Investigator will maintain all study records according to applicable University regulatory requirement(s). Hard copy records will be retained for at least 7 years after the last clinic follow-up visit at the Missouri Orthopaedic Institute in a locked filing cabinet. Electronic records will be retained for the same amount of time but on secured computers and servers. If the Investigator withdraws from the responsibility of keeping the study records, custody will be transferred to a person willing to accept the responsibility.
Related trials for Avascular Necrosis of the Talus
RecruitingObservational study
Patient Specific Talus Spacer Post Approval Study
Avascular Necrosis of the Talus
Enrolling by invitationObservational study
Prospective Evaluation of Clinical and Radiographic Outcomes Following Total Talus Replacement (PROCLAIM)
Avascular Necrosis of the Talus, Talar Osteochondral Defect of Ankle
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kyle M Schweser, MD principal investigator
Assistant Professor Orthopaedic Trauma/Foot and Ankle
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Avascular Necrosis of the Talus, run by Kyle Schweser MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vicki L Jones, M Ed (5738827583, jonesvicki@health.missouri.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change Range of motion (time frame: 12 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03965143, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.