Foot Deformities, AcquiredPhase 4NCT02161016
A Clinical Study of Outcomes in Foot and Ankle Bone Grafting Using map3® Cellular Allogeneic Bone Graft
A Phase 4 study testing map3 in people with Foot Deformities, Acquired and Disorder of Joint of Foot, run by RTI Surgical at 1 site in United States.
Trial summary
This is a single arm pilot study in patients requiring surgical fusion in the foot or ankle. Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells. This cohort study will enroll 24 patients total at 1 site. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Foot Deformities, Acquired, Disorder of Joint of Foot, Fracture of Foot
- What is being tested?
- map3
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Jan 2015
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Study subjects will be limited to patients with foot/ankle pathologies requiring fusion, which include midfoot, hindfoot, ankle, double and triple arthrodesis using open surgical technique with supplemental bone graft substitute.
- Life expectancy of at least twenty four (24) months
- Ability to give written informed consent
- All subjects will have a minimum age of eighteen (18) years and a maximum of eighty (80) years.
- Both male and non-pregnant female subjects will be included.
- To facilitate follow-up, study subjects will be limited to the local geographic area of the study site and must be willing to use the rehabilitation facility and physical therapy schedule assigned by the surgeon.
- All subjects must be able to read, write, and comprehend instructions and guidelines in English and understand (and sign as an acknowledgment of their understanding) an informed consent declaration
Who cannot join
- Patients who have been diagnosed with Charcot foot
- Patients requiring osteotomies or undergoing a revision surgery for non-union
- Patients with additional lower limb injuries requiring concomitant procedures not related to the current foot/ankle procedure
- Patients with soft tissue compromise involving open and/or infected wounds on the study limb
- Patients requiring any other bone grafting product other than study product (map3® Cellular Allogeneic Bone Graft) e.g. rhBMP2 (recombinant human bone morphogenetic protein 2).
- Patients with confirmed diagnosis of abnormal lower limb vasculature or peripheral vascular disease
Show all 22Show fewer
- Patients with a high Body Mass Index ( BMI > 35)
- Diagnosis of osteonecrosis, metabolic bone diseases or gout
- Diabetic patients who are insulin dependent
- Patients who have received any treatment within the past 12 months which may interfere with bone metabolism (bisphosphonates and/or calcitonin).
- Patients using glucocorticoids > 10 mg/day
- Chronic use (≥ 90 days) of non-steroidal anti-inflammatory drugs (NSAIDS)
- Patients with active cancer or a history of any cancer
- Known allergies to Dimethyl Sulfoxide (DMSO) and/or Human Serum Albumin (HSA)
- Pregnant or lactating females or who are capable of reproduction and will not take acceptable measures to prevent reproduction during the study
- Patients who have tested positive for HTLV, HIV, hepatitis B or hepatitis C, have rheumatoid arthritis, an autoimmune disease or are on chronic immunosuppressive medications
- Require chronic use (≥ 90 days) of anticoagulation therapy
- Active smokers unwilling to comply with surgeons instructions to stop smoking seven (7) days prior to surgery through three (3) month post-op visit
- History of alcohol or drug abuse within 90 days of screening
- Patients currently enrolled or have been enrolled in clinical studies evaluating investigational devices, pharmaceuticals or biologics within 90 days of enrollment.
- Patients unable to give written informed consent and any vulnerable patient population
- Inability to comply with all requirements of this investigation, as well as follow the instructions of the physician
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Radiographic and Clinical Outcomes Study Evaluating map3® Cellular Allogeneic Bone Graft in Patients Undergoing Bone Grafting in the Foot/Ankle
This is a single arm pilot study in patients requiring surgical fusion in the foot or ankle. Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells. This cohort study will enroll 24 patients total at 1 site. After subjects have signed an informed consent, the baseline visit and examinations will be completed. Patients will be evaluated at 2 weeks, 6 weeks, 3 months, 6 months, 12 months, and 24 months after surgery.
Read the detailed description
map3® Cellular Allogeneic Bone Graft provides the desired osteoconductive, osteoinductive and osteogenic potential capacities which are essential to optimal fracture healing when bone grafts are implanted. It offers viable MAPC-class cells on a scaffold comprised of demineralize bone matrix (DBM) and cortical cancellous chips. map3® Cellular Allogeneic Bone Graft is considered an allograft, and as such, is indicated for bone repair for orthopaedic indications where autograft is employed. The primary goal of this study is to evaluate the outcomes in bone grafts of the foot or ankle using a stem cell modified allograft (map3® Cellular Allogeneic Bone Graft). The study endpoints will be objectively determined via x-rays and CT scan to assess bony fusion, extremity evaluation using the AFAS and subjective patient scores for foot disabilities and quality of life.
- Conditions
- Foot Deformities, Acquired, Disorder of Joint of Foot, Fracture of Foot, Deformity of Bone
- Being tested
- map3
- Medical subject headings
- Foot Deformities, Acquired
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
map3Device
Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells.
| Study group | Role | What they receive |
|---|---|---|
| map3 allogeneic bone graft | Other | Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells. Receives: Device: map3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AOFAS Foot-and-Ankle Score
The American Orthopaedic Foot and Ankle Society score returns an indexed score, from 0 - 100, to assess clinical outcomes following foot /ankle surgery.
Measured: 24 months
Secondary outcomes (3)
SF-36 Score
The SF-36 is a survey for health and well-being.
Measured: 24 months
Foot Ankle Disability Index
The Foot Ankle Disability Index (FADI) is a self-report of function that assesses activities of daily living, with scores ranging from 0 to 100.
Measured: 24 months
CT Scan
A CT scan will be done at 6 months in order to assess bone fusion.
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 posted11 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionJan 2015
- Study completionJan 2015
Why it stopped: slow recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Foot Deformities, AcquiredStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- RTI Surgical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Craig Radnay, MD, Principal investigator, Saint Francis Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02161016
- Sponsor's protocol ID
- map3-2014
- Status last verified
- Feb 2015
- First submitted
- 6 Jun 2014
- Last updated
- 1 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Guyton GP, Miller SD. Stem cells in bone grafting: Trinity allograft with stem cells and collagen/beta-tricalcium phosphate with concentrated bone marrow aspirate. Foot Ankle Clin. 2010 Dec;15(4):611-9. doi: 10.1016/j.fcl.2010.09.003.
PubMed 21056860Clements JR. Use of allograft cellular bone matrix in multistage talectomy with tibiocalcaneal arthrodesis: a case report. J Foot Ankle Surg. 2012 Jan-Feb;51(1):83-6. doi: 10.1053/j.jfas.2011.09.002. Epub 2011 Oct 20.
PubMed 22014833
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Radiographic and Clinical Outcomes Study Evaluating map3® Cellular Allogeneic Bone Graft in Patients Undergoing Bone Grafting in the Foot/Ankle
- ClinicalTrials.gov ID
- NCT02161016
- Acronym / sponsor ID
- map3-2014
- Conditions
- Foot Deformities, Acquired, Disorder of Joint of Foot, Fracture of Foot, Deformity of Bone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow recruitment
- Enrolment
- 1 participants (actual)
- Lead sponsor
- RTI SurgicalIndustry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 11 Jun 2014 (estimated)
- Results
- Posted 1 Apr 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single arm pilot study in patients requiring surgical fusion in the foot or ankle. Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells. This cohort study will enroll 24 patients total at 1 site. After subjects have signed an informed consent, the baseline visit and examinations will be completed. Patients will be evaluated at 2 weeks, 6 weeks, 3 months, 6 months, 12 months, and 24 months after surgery.
Detailed description
map3® Cellular Allogeneic Bone Graft provides the desired osteoconductive, osteoinductive and osteogenic potential capacities which are essential to optimal fracture healing when bone grafts are implanted. It offers viable MAPC-class cells on a scaffold comprised of demineralize bone matrix (DBM) and cortical cancellous chips. map3® Cellular Allogeneic Bone Graft is considered an allograft, and as such, is indicated for bone repair for orthopaedic indications where autograft is employed. The primary goal of this study is to evaluate the outcomes in bone grafts of the foot or ankle using a stem cell modified allograft (map3® Cellular Allogeneic Bone Graft). The study endpoints will be objectively determined via x-rays and CT scan to assess bony fusion, extremity evaluation using the AFAS and subjective patient scores for foot disabilities and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| map3 allogeneic bone graft | Other | Device: map3Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Study subjects will be limited to patients with foot/ankle pathologies requiring fusion, which include midfoot, hindfoot, ankle, double and triple arthrodesis using open surgical technique with supplemental bone graft substitute.
- Life expectancy of at least twenty four (24) months
- Ability to give written informed consent
- All subjects will have a minimum age of eighteen (18) years and a maximum of eighty (80) years.
- Both male and non-pregnant female subjects will be included.
Key exclusion criteria (22 listed)
- Patients who have been diagnosed with Charcot foot
- Patients requiring osteotomies or undergoing a revision surgery for non-union
- Patients with additional lower limb injuries requiring concomitant procedures not related to the current foot/ankle procedure
- Patients with soft tissue compromise involving open and/or infected wounds on the study limb
- Patients requiring any other bone grafting product other than study product (map3® Cellular Allogeneic Bone Graft) e.g. rhBMP2 (recombinant human bone morphogenetic protein 2).
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 |
|---|---|---|
| map3Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells. | Device | map3 allogeneic bone graft |
Primary outcome
AOFAS Foot-and-Ankle Score
Time frame: 24 months
The American Orthopaedic Foot and Ankle Society score returns an indexed score, from 0 - 100, to assess clinical outcomes following foot /ankle surgery.
3 secondary outcomes
SF-36 Score
Time frame: 24 months
Foot Ankle Disability Index
Time frame: 24 months
CT Scan
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21056860Guyton GP, Miller SD. Stem cells in bone grafting: Trinity allograft with stem cells and collagen/beta-tricalcium phosphate with concentrated bone marrow aspirate. Foot Ankle Clin. 2010 Dec;15(4):611-9. doi: 10.1016/j.fcl.2010.09.003.
- Background: PubMed 22014833Clements JR. Use of allograft cellular bone matrix in multistage talectomy with tibiocalcaneal arthrodesis: a case report. J Foot Ankle Surg. 2012 Jan-Feb;51(1):83-6. doi: 10.1053/j.jfas.2011.09.002. Epub 2011 Oct 20.
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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.
Craig Radnay, MD principal investigator
Saint Francis Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing map3 in people with Foot Deformities, Acquired and Disorder of Joint of Foot, run by RTI Surgical at 1 site 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 22 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: stopped early, as of the sponsor's last update on 1 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Apr 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
AOFAS Foot-and-Ankle Score (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02161016, which also lists 2 linked publications.
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 1 Apr 2015; AzTrials last refreshed its copy on 7 Nov 2026.