Clinical trial NCT04503759: Artoss Foot and Ankle Surgery Registry
Official title: Multicenter Prospective Registry to Evaluate Use and Outcomes of NanoBone in Foot and Ankle Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthritis Foot
Trauma Injury
Deformity; Bone
Lead sponsor: Artoss Inc.
Sponsor class: INDUSTRY
First posted: 2020-08-07
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Radiographic Success
timeFrame: 6-months
Secondary outcomes:
measure: Safety Evaluation
timeFrame: 6-months
Other outcomes:
measure: Clinical Success
timeFrame: 6-months
measure: Function
timeFrame: 6-months
Locations:
city: Scottsdale
country: United States
facility: Phoenix Foot and Ankle Institute
state: Arizona
city: Sarasota
country: United States
facility: Florida Orthopedic Foot & Ankle Center
state: Florida
city: Joliet
country: United States
facility: Illinois Orthopedic Institute
state: Illinois
city: Morrison
country: United States
facility: Morrison Hospital
state: Illinois
city: Indianapolis
country: United States
facility: Podiatry Associates of Indiana
state: Indiana
city: Kokomo
country: United States
facility: Hoosier Foot and Ankle
state: Indiana
city: West Des Moines
country: United States
facility: The Iowa Clinic
state: Iowa
city: Duluth
country: United States
facility: Orthopedic Associates of Duluth
state: Minnesota
Study officials:
affiliation: Artoss Inc.
name: Jim Cassidy, PhD
role: STUDY_DIRECTOR
References: