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出境医 / 临床实验 / Talus Replacement Registry (3DTalar)

Talus Replacement Registry (3DTalar)

Study Description
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

Condition or disease Intervention/treatment
Avascular Necrosis of the Talus Device: 3D talar augmentation

Detailed Description:
After patients have undergone a standard of care 3D talar augment procedure they will return to clinic at designated time periods (2 weeks, 6 weeks, 3 months, 6 months, 1 year). X-rays performed as standard of care will be evaluated. Walking speed will be assessed after patient is allowed to bear weight at the same designated time periods reported above. Patients will also answer questions regarding pain (VAS survey), satisfaction (SSQ-8 survey), outcomes utilizing AAOS foot and ankle scores (survey), and self-reported return to unassisted ambulation. Goniometer measurements will be taken in the clinic at all post-operative visits to determine ROM
Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Talus Replacement Registry
Actual Study Start Date : January 1, 2020
Estimated Primary Completion Date : May 1, 2025
Estimated Study Completion Date : June 1, 2025
Arms and Interventions
Group/Cohort Intervention/treatment
3D talar group
Patients that will undergo a 3D custom talar augment
 Device: 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
Outcome Measures
Primary Outcome Measures :
  1. Change Range of motion [ Time Frame: 12 months ]
    Measures with a Goniometer and expressed in degrees

  2. Change in VAS pain Score [ Time Frame: 12 months ]
    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."

  3. Change in AAOS foot an ankle score [ Time Frame: 12 months ]
    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.

  4. SSQ-8 satisfaction score [ Time Frame: 12 months ]
    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.

  5. Change in walking speed [ Time Frame: 12 months ]
    Speed will be measured in seconds over a standard distance


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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
Contacts and Locations

Contacts
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Contact: Stacee W Clawson, RN (573) 884-9017 clawsons@health.missouri.edu
Contact: Ennio R Esposito, MD 3468126445 eardvb@health.missouri.edu

Locations
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United States, Missouri
University of Missouri Recruiting
Columbia, Missouri, United States, 65212
Contact: Ennio R Esposito    573-882-7615    eardvb@health.missouri.edu   
Sponsors and Collaborators
Kyle Schweser MD
Investigators
Layout table for investigator information
Principal Investigator: Kyle M Schweser, MD Assistant Professor Orthopaedic Trauma/Foot and Ankle
Tracking Information
First Submitted Date May 14, 2019
First Posted Date May 28, 2019
Last Update Posted Date May 3, 2021
Actual Study Start Date January 1, 2020
Estimated Primary Completion Date May 1, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 24, 2019)
  • Change Range of motion [ Time Frame: 12 months ]
    Measures with a Goniometer and expressed in degrees
  • Change in VAS pain Score [ Time Frame: 12 months ]
    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."
  • Change in AAOS foot an ankle score [ Time Frame: 12 months ]
    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.
  • SSQ-8 satisfaction score [ Time Frame: 12 months ]
    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.
  • Change in walking speed [ Time Frame: 12 months ]
    Speed will be measured in seconds over a standard distance
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Talus Replacement Registry
Official Title Talus Replacement Registry
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
Detailed Description After patients have undergone a standard of care 3D talar augment procedure they will return to clinic at designated time periods (2 weeks, 6 weeks, 3 months, 6 months, 1 year). X-rays performed as standard of care will be evaluated. Walking speed will be assessed after patient is allowed to bear weight at the same designated time periods reported above. Patients will also answer questions regarding pain (VAS survey), satisfaction (SSQ-8 survey), outcomes utilizing AAOS foot and ankle scores (survey), and self-reported return to unassisted ambulation. Goniometer measurements will be taken in the clinic at all post-operative visits to determine ROM
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 12 Months
Biospecimen Not Provided
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
Condition Avascular Necrosis of the Talus
Intervention Device: 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
Study Groups/Cohorts 3D talar group
Patients that will undergo a 3D custom talar augment
Intervention: Device: 3D talar augmentation
Publications *
  • 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. Review.
  • 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.
  • 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.
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 24, 2019) 		50
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 1, 2025
Estimated Primary Completion Date May 1, 2025   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Stacee W Clawson, RN (573) 884-9017 clawsons@health.missouri.edu
Contact: Ennio R Esposito, MD 3468126445 eardvb@health.missouri.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03965143
Other Study ID Numbers 2014893
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: The Investigator will maintain all study records according to applicable University regulatory requirement(s). Hard copy records will be retained for at least 7 years after the last clinic follow-up visit at the Missouri Orthopaedic Institute in a locked filing cabinet. Electronic records will be retained for the same amount of time but on secured computers and servers. If the Investigator withdraws from the responsibility of keeping the study records, custody will be transferred to a person willing to accept the responsibility.
Responsible Party Kyle Schweser MD, University of Missouri-Columbia
Study Sponsor Kyle Schweser MD
Collaborators Not Provided
Investigators
Principal Investigator: Kyle M Schweser, MD Assistant Professor Orthopaedic Trauma/Foot and Ankle
PRS Account University of Missouri-Columbia
Verification Date April 2021