Arthritis FootARKNCT04503759
Artoss Foot and Ankle Surgery Registry
An observational study of Arthritis Foot and Trauma Injury, run by Artoss Inc. at 8 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis Foot, Trauma Injury, Deformity; Bone
- What is being tested?
- NanoBone Bone Graft Substitute
- How many people
- 200 participants
- Where
- 8 sitesUnited States
- Study dates
- 1 Aug 2020to 10 May 2024
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Orthopedic Associates of Duluth
Duluth, Minnesota, 55805
Podiatry Associates of Indiana
Indianapolis, Indiana, 46254
Illinois Orthopedic Institute
Joliet, Illinois, 60435
Hoosier Foot and Ankle
Kokomo, Indiana, 46901
Morrison Hospital
Morrison, Illinois, 61270
Florida Orthopedic Foot & Ankle Center
Sarasota, Florida, 34239
Phoenix Foot and Ankle Institute
Scottsdale, Arizona, 85251
The Iowa Clinic
West Des Moines, Iowa, 50266
About this study
Official title: Multicenter Prospective Registry to Evaluate Use and Outcomes of NanoBone in Foot and Ankle Surgery
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.
Read the 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.
- Conditions
- Arthritis Foot, Trauma Injury, Deformity; Bone
- Being tested
- NanoBone Bone Graft Substitute
- Medical subject headings
- Accidental Injuries, Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NanoBone Bone Graft SubstituteOther
Also called nanoHA-SiO2
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: NanoBone Bone Graft Substitute |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6-months
Secondary outcomes (1)
Safety Evaluation
Occurrence of Complications or Adverse Events
Measured: 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2020
- Study start1 Aug 2020
- Primary completion10 May 2024
- Study completion10 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis FootStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Artoss Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jim Cassidy, PhD, Study director, Artoss Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04503759
- Sponsor's protocol ID
- HAF002
- Acronym
- ARK
- Status last verified
- May 2024
- First submitted
- 30 Jul 2020
- Last updated
- 13 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Prospective Registry to Evaluate Use and Outcomes of NanoBone in Foot and Ankle Surgery
- ClinicalTrials.gov ID
- NCT04503759
- Acronym / sponsor ID
- ARK / HAF002
- Conditions
- Arthritis Foot, Trauma Injury, Deformity; Bone
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Artoss Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 10 May 2024 (actual)
- Study completion
- 10 May 2024 (actual)
- First posted
- 7 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Foot and Ankle Surgery using NanoBone | – | Other: NanoBone Bone Graft SubstituteAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- Severe vascular or neurological disease
- Uncontrolled diabetes
- Severe degenerative disease (other than degenerative disc disease)
- Severely impaired renal function
- Hypercalcemia, abnormal calcium metabolism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NanoBone Bone Graft SubstituteAlso: nanoHA-SiO2Synthetic, 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 | Foot and Ankle Surgery using NanoBone |
Primary outcome
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.
1 secondary outcome
Safety Evaluation
Time frame: 6-months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jim Cassidy, PhD study director
Artoss Inc.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthritis Foot and Trauma Injury, run by Artoss Inc. at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic Success (time frame: 6-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2024.