ViviGen Cellular Bone Matrix for Hindfoot or Ankle Arthrodesis

Ankle Arthritis Clinical Trial

— ViviGen  

Official title:

Clinical and Radiographic Outcomes Using ViviGen® Cellular Bone Matrix for Complex Hindfoot Arthrodesis

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04138017
• Other study ID #: 20532
• Status: Enrolling by invitation
• Phase: Phase 4
• 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
• 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

Related Conditions & MeSH terms

• Ankle Arthritis
• Ankle Deformity
• Arthritis
• Congenital Abnormalities

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