ViviGen Cellular Bone Matrix for Hindfoot or Ankle Arthrodesis

Phase 4

• Conditions: Ankle Arthritis; Ankle Deformity
• Interventions: Device: ViviGen

• Registration Number: NCT04138017
• Lead Sponsor: University of Virginia

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-23
• Study First Submitted: 2019-01-02
• Study First Submitted QC: 2019-10-22
• Study First Posted: 2019-10-24
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-08
• Last Update Posted: 2022-02-25
• Primary Completion: 2023-05
• Study Completion: 2024-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ViviGen Cellular Bone Matrix	ViviGen	Patients will receive the vivigen cellular bone matrix

Primary Outcome Measures

Name	Time	Method
Fusion	12 months	Radiographic evidence of successful arthrodesis confirmed on Computed Tomography (CT) scan defined by \>50%

Secondary Outcome Measures

Name	Time	Method
Visual Analog Pain Scale	12 months	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.
Failure of hardware or obvious non-union	12 months	Failure measured through clinical and radiographic evidence
Foot and Ankle Ability Measure (FAAM)	12 months	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)
American Orthopaedic Foot and Ankle Society(AOFAS) hindfoot score	12 months	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.
VR-12 (Veterans RAND 12)	12 months	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.
Vitamin D levels	6 months	25-Hydroxyvitamin D2 and D3 Blood test
Patient-Reported Outcomes Measurement Information System Physical Function-Short Form 8b (PROMIS Item Bank v2.0-Physical Function -Short Form 8b)	12 months	Patient self-reported capability for physical function using 8 questions to assess current function of an adult in the general population.

Trial Locations

Locations (1)

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States