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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04138017
Other study ID # 20532
Secondary ID
Status Enrolling by invitation
Phase Phase 4
First received
Last updated
Start date October 23, 2018
Est. completion date January 2024

Study information

Verified date February 2022
Source University of Virginia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To evaluate the fusion status of the hindfoot bones after receiving the ViviGen graft, an FDA approved cellular bone matrix. This is used in a population indicated for hindfoot arthrodesis as an alternative to an autograft.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 15
Est. completion date January 2024
Est. primary completion date May 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - Patient with prescribed standard of care unilateral hindfoot ankle arthrodesis procedure - Age 18-80 - Willing to complete all follow up evaluations Exclusion Criteria: - Prior infection at site of planned arthrodesis - Prior arthrodesis procedure - Inability to maintain non-weight bearing status - Bone defect requiring more than 10 cc of bone graft material - Known Vitamin D deficiency with a Vitamin D level of <30ng/ml 1 week prior to surgery - Inadequate bone stock to allow for rigid internal fixation - Hemoglobin A1C greater than 8.0% - Tobacco or Nicotine use 6 weeks prior to surgery - BMI greater than 40

Study Design


Intervention

Device:
ViviGen
A cellular bone matrix which includes viable osteoblasts within a corticocancellous and demineralized bone carrier, represents a unique alternative to autograft or existing products which utilize mesenchymal stem cells.

Locations

Country Name City State
United States University of Virginia Charlottesville Virginia

Sponsors (2)

Lead Sponsor Collaborator
University of Virginia DePuy Synthes

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Fusion Radiographic evidence of successful arthrodesis confirmed on Computed Tomography (CT) scan defined by >50% 12 months
Secondary Failure of hardware or obvious non-union Failure measured through clinical and radiographic evidence 12 months
Secondary Foot and Ankle Ability Measure (FAAM) Patient reported outcome measurement that includes 29-item questionnaire divided into two subscales: 21-item activities of daily living subscale and 8-item sports subscale. Response options are given in 5 point Likert scales (range from 4-0) 12 months
Secondary Vitamin D levels 25-Hydroxyvitamin D2 and D3 Blood test 6 months
Secondary Visual Analog Pain Scale Patient Foot pain reported on a 10 Centimeter line. Patient is asked to draw a vertical line where they believe their pain falls at rest and when active. This is on a scale of 0-10 with 0 being no pain and 10 being the most pain. 12 months
Secondary American Orthopaedic Foot and Ankle Society(AOFAS) hindfoot score Patient reported outcome for a standardized evaluation of clinical status of ankle- hindfoot. Patient reports their pain and the physician records physical assessment of alignment. Finally function is reported and the AOFAS score ranged from 0-100 with 100 being healthy ankles. 12 months
Secondary VR-12 (Veterans RAND 12) Patient reported outcome for health related quality of life using a 12 item questionnaire. This is broken into two scores: Physical Health component scores, and Mental Health component scores. 12 months
Secondary Patient-Reported Outcomes Measurement Information System Physical Function-Short Form 8b (PROMIS Item Bank v2.0-Physical Function -Short Form 8b) Patient self-reported capability for physical function using 8 questions to assess current function of an adult in the general population. 12 months
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