Artoss Foot and Ankle Surgery Registry

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational [Patient Registry]
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04503759
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Artoss Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Steven M Czop, R.Ph.
Principal Investigator Affiliation Artoss Inc.
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Arthritis Foot, Trauma Injury, Deformity; Bone
Additional Details

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.

Arms & Interventions

Arms

: 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.

Interventions

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

OrthoArizona, Chandler, Arizona

Status

Recruiting

Address

OrthoArizona

Chandler, Arizona, 85226

Site Contact

Lewis Freed, DPM

[email protected]

(320) 259-4321

Phoenix Foot and Ankle Institute, Scottsdale, Arizona

Status

Recruiting

Address

Phoenix Foot and Ankle Institute

Scottsdale, Arizona, 85251

Site Contact

Jeffrey E McAlister, DPM

[email protected]

(320) 259-4321

Florida Orthopedic Foot & Ankle Center, Sarasota, Florida

Status

Recruiting

Address

Florida Orthopedic Foot & Ankle Center

Sarasota, Florida, 34239

Site Contact

James M Cottom, DPM

[email protected]

(320) 259-4321

Illinois Orthopedic Institute, Joliet, Illinois

Status

Recruiting

Address

Illinois Orthopedic Institute

Joliet, Illinois, 60435

Site Contact

Joe Mathew George, DPM

[email protected]

(320) 259-4321

Morrison Hospital, Morrison, Illinois

Status

Recruiting

Address

Morrison Hospital

Morrison, Illinois, 61270

Site Contact

David A Yeager, DPM

[email protected]

(320) 259-4321

Anderson Orthopedic Clinic, Arlington, Virginia

Status

Recruiting

Address

Anderson Orthopedic Clinic

Arlington, Virginia, 22206

Site Contact

Oliver N Schipper, MD

[email protected]

(320) 259-4321