Talus Replacement Registry

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorKyle Schweser MD

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: 3D talar group1 intervention

Trial outcomes

Primary outcomes

1

Change Range of motion

Measures with a Goniometer and expressed in degrees

Time frame
12 months
2

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."

Time frame
12 months
3

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.

Time frame
12 months
4

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.

Time frame
12 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kyle Schweser MD

Lead sponsor

University of Missouri-Columbia

Sponsor institution