Registry for 3D talus replacement in patients with avascular necrosis
Talus Replacement Registry
This study is testing a new 3D talus replacement procedure to see if it helps people with avascular necrosis of the talus recover better and improve their foot function.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Missouri-Columbia Academic / other |
| Locations | 1 site (Columbia, Missouri) |
| Trial ID | NCT03965143 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients with avascular necrosis of the talus who undergo a 3D talar augmentation procedure. Participants will return for follow-up visits at specified intervals to assess their recovery through X-rays, walking speed evaluations, and various surveys measuring pain, satisfaction, and overall outcomes. The aim is to gather data on the effectiveness of this innovative approach in restoring foot function and mobility. The study seeks to provide valuable insights into the long-term benefits and potential complications associated with this treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who require total talus replacement due to avascular necrosis.
Not a fit: Patients with active infections, those unable to consent, or individuals whose condition does not qualify for total talus replacement may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for patients suffering from avascular necrosis of the talus, enhancing their mobility and quality of life.
How similar studies have performed: While the use of 3D printing in orthopedic procedures is gaining traction, this specific approach to talus replacement is relatively novel and requires further validation.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Columbia, Missouri
- University of Missouri — Columbia, Missouri, United States (Recruiting)
Study contacts
- Principal investigator: Kyle M Schweser, MD — Assistant Professor Orthopaedic Trauma/Foot and Ankle
- Study coordinator: Vicki L Jones, M Ed
- Email: jonesvicki@health.missouri.edu
- Phone: 5738827583
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.