RECRUITING

Talus Replacement Registry

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Talus Replacement Registry

Quick Facts

Study Start:2020-01-01
Study Completion:2025-06-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03965143

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Not specified
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Subjects age 18 years or above at time of screening
  2. 2. Condition satisfies requirement for total talus replacement
  3. 3. Able to consent and participate in the study
  4. 4. No previous history of septic arthritis involving the hindfoot/midfoot
  5. 5. Previous ability to ambulate
  1. 1. Active infection, sepsis, osteomyelitis or history of septic arthritis involving the hindfoot/midfoot
  2. 2. Unable to consent or participate in the study secondary to mental status
  3. 3. Condition does not qualify for a total talus replacement
  4. 4. Patients who are pregnant or imprisoned
  5. 5. Planned relocation or unable to return for required follow-up visits

Contacts and Locations

Study Contact

Vicki L Jones, M Ed
CONTACT
5738827583
jonesvicki@health.missouri.edu

Principal Investigator

Kyle M Schweser, MD
PRINCIPAL_INVESTIGATOR
Assistant Professor Orthopaedic Trauma/Foot and Ankle

Study Locations (Sites)

University of Missouri
Columbia, Missouri, 65212
United States

Collaborators and Investigators

Sponsor: Kyle Schweser MD

  • Kyle M Schweser, MD, PRINCIPAL_INVESTIGATOR, Assistant Professor Orthopaedic Trauma/Foot and Ankle

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-01-01
Study Completion Date2025-06-01

Study Record Updates

Study Start Date2020-01-01
Study Completion Date2025-06-01

Terms related to this study

Additional Relevant MeSH Terms

  • Avascular Necrosis of the Talus