Recruiting

3D Custom Talus

Sponsor:

Kyle Schweser MD

Code:

NCT03965143

Conditions

Avascular Necrosis of the Talus

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

3D talar augmentation

Study Details

Brief 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 time after the procedure

Conditions

Avascular Necrosis of the Talus

Study ID

NCT03965143

Start date

Jan 1, 2020

Status verified date

Apr, 2026

Completion date

May 1, 2027

Anticipated

Primary completion date

May 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Subjects age 18 years or above at time of screening
2. Condition satisfies requirement for total talus replacement
3. Able to consent and participate in the study
4. No previous history of septic arthritis involving the hindfoot/midfoot
5. Previous ability to ambulate

Exclusion Criteria:

1. Active infection, sepsis, osteomyelitis or history of septic arthritis involving the hindfoot/midfoot
2. Unable to consent or participate in the study secondary to mental status
3. Condition does not qualify for a total talus replacement
4. Patients who are pregnant or imprisoned
5. Planned relocation or unable to return for required follow-up visits

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

3D talar group

Patients that will undergo a 3D custom talar augment

Interventions

3D talar augmentation

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

Primary outcome measure

  • Change Range of motion [ Time Frame: 12 months ]
  • Change in VAS pain Score [ Time Frame: 12 months ]
  • Change in AAOS foot an ankle score [ Time Frame: 12 months ]
  • SSQ-8 satisfaction score [ Time Frame: 12 months ]
  • Change in walking speed [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Locations

University of Missouri

Recruiting

Columbia, Missouri, United States, 65212

Contacts

More Information

Sponsor

Kyle Schweser MD

Last update posted

Apr 28, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Kyle Schweser MD on 2026-04-28.