Talus Replacement Registry

NCT03965143 | Recruiting

• 1 other identifier: 2014893
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (5)

• Change Range of motion

  Measures with a Goniometer and expressed in degrees

  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."

  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.

  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.

  12 months

• Change in walking speed

  Speed will be measured in seconds over a standard distance

  12 months

Study Arms (1)

3D talar group

Patients that will undergo a 3D custom talar augment

Device: 3D talar augmentation

Interventions

3D talar augmentation DEVICE

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

3D talar group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients over 18 years of age diagnosed with avascular necrosis of the talar body and amenable to treatment with 3D custom augmentation

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kyle Schweser MD: lead

Study Sites (1)

University of Missouri

Columbia, Missouri, 65212, United States

RECRUITING

Related Publications (4)

• 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.

  PMID: 22187841 BACKGROUND

• Ketz 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.

  PMID: 22760387 BACKGROUND

• Wagener 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.

  PMID: 28148666 RESULT

• Tracey 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.

  PMID: 29537314 RESULT

Study Officials

• Kyle M Schweser, MD

  Assistant Professor Orthopaedic Trauma/Foot and Ankle

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vicki L Jones, M Ed

CONTACT

5738827583; jonesvicki@health.missouri.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor Orthopaedic Trauma/Foot and Ankle

Study Record Dates

• First Submitted: May 14, 2019
• First Posted: May 28, 2019
• Study Start: January 1, 2020
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)