Artoss Foot and Ankle Surgery Registry

NCT04503759 | Completed DMC

• 1 other identifier: HAF002
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 8

Brief Summary

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.

Conditions

Arthritis Foot; Trauma Injury; Deformity; Bone

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Safety Evaluation

  6-months

Other Outcomes (2)

• Clinical Success

  6-months

• Function

  6-months

Study Arms (1)

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

Interventions

NanoBone Bone Graft Substitute OTHER

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.

Also known as: nanoHA-SiO2

Foot and Ankle Surgery using NanoBone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Artoss Inc.: lead

Study Sites (8)

Phoenix Foot and Ankle Institute

Scottsdale, Arizona, 85251, United States

Location

Florida Orthopedic Foot & Ankle Center

Sarasota, Florida, 34239, United States

Location

Illinois Orthopedic Institute

Joliet, Illinois, 60435, United States

Location

Morrison Hospital

Morrison, Illinois, 61270, United States

Location

Podiatry Associates of Indiana

Indianapolis, Indiana, 46254, United States

Location

Hoosier Foot and Ankle

Kokomo, Indiana, 46901, United States

Location

The Iowa Clinic

West Des Moines, Iowa, 50266, United States

Location

Orthopedic Associates of Duluth

Duluth, Minnesota, 55805, United States

Location

MeSH Terms

Conditions

Accidental Injuries; Congenital Abnormalities

Condition Hierarchy (Ancestors)

Wounds and Injuries; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Jim Cassidy, PhD

  Artoss Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2020
• First Posted: August 7, 2020
• Study Start: August 1, 2020
• Primary Completion: May 10, 2024
• Study Completion: May 10, 2024
• Last Updated: May 13, 2024

Record last verified: 2024-05

Locations

US (8)