ViviGen Cellular Bone Matrix for Hindfoot or Ankle Arthrodesis

Phase 4

Completed

• Conditions: Ankle Arthritis; Ankle Deformity

• 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
• Primary Completion: 2023-04-10
• Study Completion: 2023-12-01
• Results First Submitted: 2025-05-21
• Status Verified: 2025-06
• Results First Submitted QC: 2025-06-17
• Last Update Submitted: 2025-06-17
• Results First Posted: 2025-06-19
• Last Update Posted: 2025-06-19

Recruitment & Eligibility

• Status: COMPLETED
• 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: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Union Rates	12 months	Radiographic evidence of successful arthrodesis confirmed on Computed Tomography (CT) scan defined by \>50%. Results are for total number of joints fused which exceeds the number of participants due to some subjects having multiple joints fused.

Secondary Outcome Measures

Name	Time	Method
Failure of Hardware or Obvious Non-union	12 months	Failure measured through clinical and radiographic evidence
Foot and Ankle Ability Measure (FAAM) - Activities of Daily Living (ADL) Subscale	baseline, 3 month, 6 month, 1 year	For this study, the researchers only utilized the ADL subscale. This patient-reported outcome measure is a 21-item questionnaire assessing fundamental mobility and daily activities. Responses use a 5-point Likert scale ranging from 4 (no difficulty) to 0 (unable to do), with N/A responses excluded. The responses are summed, and the total possible score is calculated by multiplying the number of answered items by 4 (maximum score: 84). The total score is divided by the highest potential score, then multiplied by 100 to yield a percentage. Higher percentages indicate greater physical function, with 100% representing no functional limitations, on the ADL subscale.
Vitamin D Levels	baseline, 6 months	25-Hydroxyvitamin D is the primary circulating form of vitamin D and is the most commonly used measure to assess vitamin D status in the blood. The reference range for 25-hydroxy vitamin D test is 20-80 ng/mL. A low test level would indicate lower concentrations of Vitamin D.
American Orthopaedic Foot and Ankle Society(AOFAS) Hindfoot Score	baseline, 3 month, 6 month, 1 year	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.

Trial Locations

Locations (1)

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