Talus Replacement Registry (3DTalar)
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|ClinicalTrials.gov Identifier: NCT03965143|
Recruitment Status : Recruiting
First Posted : May 28, 2019
Last Update Posted : March 31, 2020
|Condition or disease||Intervention/treatment|
|Avascular Necrosis of the Talus||Device: 3D talar augmentation|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||50 participants|
|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|
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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03965143
|Contact: Stacee W Clawson, RN||(573) firstname.lastname@example.org|
|Contact: Ennio R Esposito, MDemail@example.com|
|United States, Missouri|
|University of Missouri||Recruiting|
|Columbia, Missouri, United States, 65212|
|Contact: Ennio R Esposito 573-882-7615 firstname.lastname@example.org|
|Principal Investigator:||Kyle M Schweser, MD||Assistant Professor Orthopaedic Trauma/Foot and Ankle|