Status:
COMPLETED
Artoss Foot and Ankle Surgery Registry
Lead Sponsor:
Artoss Inc.
Conditions:
Arthritis Foot
Trauma Injury
Eligibility:
All Genders
18+ years
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 b...
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. The...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 10 2024
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04503759
Start Date
August 1 2020
End Date
May 10 2024
Last Update
May 13 2024
Active Locations (8)
Enter a location and click search to find clinical trials sorted by distance.
1
Phoenix Foot and Ankle Institute
Scottsdale, Arizona, United States, 85251
2
Florida Orthopedic Foot & Ankle Center
Sarasota, Florida, United States, 34239
3
Illinois Orthopedic Institute
Joliet, Illinois, United States, 60435
4
Morrison Hospital
Morrison, Illinois, United States, 61270