Artoss Foot and Ankle Surgery Registry
Completed
Conditions studied: Arthritis Foot, Trauma Injury, Deformity; Bone
In brief
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.
Key facts
- Study ID
- NCT04503759
- Run by
- Artoss Inc.
- People needed
- 200
- Starts
- 2020-08-01
- Expected to finish
- 2024-05-10
- Last updated by the study team
- 2024-05-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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.
Where it is running
- Phoenix Foot and Ankle Institute — Scottsdale, Arizona, United States
- Florida Orthopedic Foot & Ankle Center — Sarasota, Florida, United States
- Illinois Orthopedic Institute — Joliet, Illinois, United States
- Morrison Hospital — Morrison, Illinois, United States
- Podiatry Associates of Indiana — Indianapolis, Indiana, United States
- Hoosier Foot and Ankle — Kokomo, Indiana, United States
- The Iowa Clinic — West Des Moines, Iowa, United States
- Orthopedic Associates of Duluth — Duluth, Minnesota, United States
Full record on ClinicalTrials.gov
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