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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04503759
Other study ID # HAF002
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 1, 2020
Est. completion date May 10, 2024

Study information

Verified date May 2024
Source Artoss Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date May 10, 2024
Est. primary completion date May 10, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

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.

Locations

Country Name City State
United States Orthopedic Associates of Duluth Duluth Minnesota
United States Podiatry Associates of Indiana Indianapolis Indiana
United States Illinois Orthopedic Institute Joliet Illinois
United States Hoosier Foot and Ankle Kokomo Indiana
United States Morrison Hospital Morrison Illinois
United States Florida Orthopedic Foot & Ankle Center Sarasota Florida
United States Phoenix Foot and Ankle Institute Scottsdale Arizona
United States The Iowa Clinic West Des Moines Iowa

Sponsors (1)

Lead Sponsor Collaborator
Artoss Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Clinical Success Change from baseline in Visual Analog Scale (VAS) pain score (0=no pain, 10=worst possible pain 6-months
Other Function Change from baseline in Foot and Ankle Ability Measure (FAAM) 6-months
Primary 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 Safety Evaluation Occurrence of Complications or Adverse Events 6-months
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