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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
Sponsor:
Information provided by (Responsible Party):
Artoss Inc.

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 bone grafting, as well as determining relevant patient outcomes.

Condition or disease Intervention/treatment
Arthritis Foot Trauma Injury Deformity; Bone Other: NanoBone Bone Graft Substitute

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. 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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Safety Evaluation [ Time Frame: 6-months ]
    Occurrence of Complications or Adverse Events


Other Outcome Measures:
  1. Clinical Success [ Time Frame: 6-months ]
    Change from baseline in Visual Analog Scale (VAS) pain score (0=no pain, 10=worst possible pain

  2. Function [ Time Frame: 6-months ]
    Change from baseline in Foot and Ankle Ability Measure (FAAM)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
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.

Information from the National Library of Medicine

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


Contacts
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Contact: Steven M Czop, R.Ph. (320) 259-4321 sczop@artossinc.com

Locations
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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 Hospital Recruiting
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         
Sponsors and Collaborators
Artoss Inc.
Investigators
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Study Director: Steven M Czop, R.Ph. Artoss Inc.
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Responsible Party: Artoss Inc.
ClinicalTrials.gov Identifier: NCT04503759    
Other Study ID Numbers: HAF002
First Posted: August 7, 2020    Key Record Dates
Last Update Posted: April 6, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Congenital Abnormalities