Trauma Injury Clinical Trial
— ARKOfficial title:
Multicenter Prospective Registry to Evaluate Use and Outcomes of NanoBone in Foot and Ankle Surgery
NCT number | NCT04503759 |
Other study ID # | HAF002 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | August 1, 2020 |
Est. completion date | May 10, 2024 |
Verified date | May 2024 |
Source | Artoss Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Artoss Inc. |
United States,
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 |
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