Artoss Foot and Ankle Surgery Registry

Trauma Injury Clinical Trial

— ARK  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04503759
• Other study ID #: HAF002
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis Foot
• Congenital Abnormalities
• Deformity; Bone
• Trauma Injury

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