Artoss Foot and Ankle Surgery Registry (ARK)

Multicenter Prospective Registry to Evaluate Use and Outcomes of NanoBone in Foot and Ankle Surgery

This prospective registry was designed as an observational study to ascertain how commercially available NanoBone products are being used by surgeons performing foot and ankle surgery which involves bone grafting, as well as determining relevant patient outcomes.

Study Overview

• Status: Completed
• Conditions: Trauma Injury; Deformity; Bone; Arthritis Foot
• Intervention / Treatment: Other: NanoBone Bone Graft Substitute

Detailed Description

This multicenter prospective patient registry was developed with the aim of documenting how surgeons are utilizing NanoBone products in foot and ankle surgery along with relevant patient outcomes. These outcomes include radiographic measures such as fusion or graft consolidation success, instrumentation integrity, and clinical outcomes (symptom and function improvement) based on investigator and patient-based outcome assessments.

The primary objective of this study is to document and analyze the use of NanoBone products in foot and ankle surgery (as a stand-alone bone graft, no other local bone, autograft, bone graft substitute, or biologic product used) and determine both radiographic success and clinical outcomes. All product related adverse events will be documented, tabulated, and summarized.

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85251
      • Phoenix Foot and Ankle Institute
  • Florida
    • Sarasota, Florida, United States, 34239
      • Florida Orthopedic Foot & Ankle Center
  • Illinois
    • Joliet, Illinois, United States, 60435
      • Illinois Orthopedic Institute
    • Morrison, Illinois, United States, 61270
      • Morrison Hospital
  • Indiana
    • Indianapolis, Indiana, United States, 46254
      • Podiatry Associates of Indiana
    • Kokomo, Indiana, United States, 46901
      • Hoosier Foot and Ankle
  • Iowa
    • West Des Moines, Iowa, United States, 50266
      • The Iowa Clinic
  • Minnesota
    • Duluth, Minnesota, United States, 55805
      • Orthopedic Associates of Duluth

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All patients in the study will be drawn from the individual surgeons' practice. Patients will be among those already scheduled for foot and ankle surgery after having failed conservative treatment, or will have had foot and ankle surgery using NanoBone products but have not completed their standard of care follow-up as determined by the surgeon's practice. In addition, the surgeon has determined that the use of a NanoBone product is or was clinically necessary for the patient. The choice of a NanoBone product, as well as the surgery, is or was independent of this research project. Only patients who have had NanoBone implanted and consent to participate and meet the inclusion-exclusion criteria will be included in the registry.

Description

Inclusion Criteria:

• Patient aged 18 years or older.
• Patient is or was diagnosed with a pathology of the foot or ankle, having failed conservative treatment, and surgeon has determined that surgery with bone graft is medically necessary.
• The surgeon has determined that NanoBone is or was clinically indicated.
• NanoBone will be or was used as a stand-alone bone graft (no autograft, other bone graft substitute, or biologic planned or used).
• Patient capable of understanding the content of the Informed Consent Form
• Patient willing and able to participate in the registry protocol including the surgeon's standard follow-up visits and clinical evaluations.
• Patient who has agreed to participate in the registry by providing consent according to the applicable local law and the declaration of Helsinki.

Exclusion Criteria:

• Severe vascular or neurological disease
• Uncontrolled diabetes
• Severe degenerative disease (other than degenerative disc disease)
• Severely impaired renal function
• Hypercalcemia, abnormal calcium metabolism
• Existing acute or chronic infections, especially at the site of the operation
• Inflammatory bone disease such as osteomyelitis
• Malignant tumors
• Patients who are or plan to become pregnant.
• Uncooperative patients who cannot or will not follow post-operative instruction, including individuals who abuse drugs and/or alcohol.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Foot and Ankle Surgery using NanoBone; All patients in the study will be drawn from the individual surgeons' practice. Patients will be among those already scheduled for foot and ankle surgery after having failed conservative treatment, or will have had foot and ankle surgery using NanoBone products but have not completed their standard of care follow-up as determined by the surgeon's practice. In addition, the surgeon has determined that the use of a NanoBone product is or was clinically necessary for the patient. The choice of a NanoBone product, as well as the surgery, is or was independent of this research project. Only patients who have had NanoBone implanted and consent to participate and meet the inclusion-exclusion criteria will be included in the registry.

Other: NanoBone Bone Graft Substitute; Synthetic, biodegradable bone grafting material that is composed of non-sintered nanocrystalline hydroxyapatite (HA) which is embedded in a silica gel matrix (amorphous SiO2). The ratio of HA/SiO2 has been chosen to optimize the rate of biodegradation for treatment of osseous defects in human bone. NanoBone does not contain any components of animal or human origin, eliminating the possibility of transmission of infection or disease.; Other Names: nanoHA-SiO2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiographic Success	Fusion/Graft Consolidation: Evidence of bony (osseous) bridging between the graft material and the patient's bone in the segment requiring fusion or reconstruction.	6-months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Evaluation	Occurrence of Complications or Adverse Events	6-months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Success	Change from baseline in Visual Analog Scale (VAS) pain score (0=no pain, 10=worst possible pain	6-months
Function	Change from baseline in Foot and Ankle Ability Measure (FAAM)	6-months

Collaborators and Investigators

• Sponsor: Artoss Inc.
• Investigators: Study Director: Jim Cassidy, PhD, Artoss Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2020
• Primary Completion (Actual): May 10, 2024
• Study Completion (Actual): May 10, 2024

Study Registration Dates

• First Submitted: July 30, 2020
• First Submitted That Met QC Criteria: August 5, 2020
• First Posted (Actual): August 7, 2020

Study Record Updates

• Last Update Posted (Actual): May 13, 2024
• Last Update Submitted That Met QC Criteria: May 10, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Arthritis; Congenital Abnormalities
• Other Study ID Numbers: HAF002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No