Artoss Foot and Ankle Surgery Registry (ARK)
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|ClinicalTrials.gov Identifier: NCT04503759|
Recruitment Status : Recruiting
First Posted : August 7, 2020
Last Update Posted : April 6, 2021
|Condition or disease||Intervention/treatment|
|Arthritis Foot Trauma Injury Deformity; Bone||Other: NanoBone Bone Graft Substitute|
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.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||250 participants|
|Target Follow-Up Duration:||6 Months|
|Official Title:||Multicenter Prospective Registry to Evaluate Use and Outcomes of NanoBone in Foot and Ankle Surgery|
|Actual Study Start Date :||August 1, 2020|
|Estimated Primary Completion Date :||July 15, 2021|
|Estimated Study Completion Date :||September 30, 2021|
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.
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.
Other Name: nanoHA-SiO2
- Radiographic Success [ Time Frame: 6-months ]Fusion/Graft Consolidation: Evidence of bony (osseous) bridging between the graft material and the patient's bone in the segment requiring fusion or reconstruction.
- Safety Evaluation [ Time Frame: 6-months ]Occurrence of Complications or Adverse Events
- Clinical Success [ Time Frame: 6-months ]Change from baseline in Visual Analog Scale (VAS) pain score (0=no pain, 10=worst possible pain
- Function [ Time Frame: 6-months ]Change from baseline in Foot and Ankle Ability Measure (FAAM)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04503759
|Contact: Steven M Czop, R.Ph.||(320) firstname.lastname@example.org|
|United States, Arizona|
|Phoenix Foot and Ankle Institute||Recruiting|
|Scottsdale, Arizona, United States, 85251|
|Contact: Jeffrey E McAlister, DPM|
|United States, Florida|
|Florida Orthopedic Foot & Ankle Center||Recruiting|
|Sarasota, Florida, United States, 34239|
|Contact: James M Cottom, DPM|
|United States, Illinois|
|Illinois Orthopedic Institute||Recruiting|
|Joliet, Illinois, United States, 60435|
|Contact: Joe Mathew George, DPM|
|Morrison, Illinois, United States, 61270|
|Contact: David A Yeager, DPM|
|United States, Iowa|
|The Iowa Clinic||Recruiting|
|West Des Moines, Iowa, United States, 50266|
|Contact: Eric Barp, DPM|
|Contact: Eric Temple, DPM|
|Study Director:||Steven M Czop, R.Ph.||Artoss Inc.|