A Clinical Study of Outcomes in Foot and Ankle Bone Grafting Using map3® Cellular Allogeneic Bone Graft
Primary Purpose
Foot Deformities, Acquired, Disorder of Joint of Foot, Fracture of Foot
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
map3
Sponsored by
About this trial
This is an interventional treatment trial for Foot Deformities, Acquired
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Sites / Locations
- Saint Francis Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
map3 allogeneic bone graft
Arm Description
Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
SF-36 Score
The SF-36 is a survey for health and well-being.
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.
CT Scan
A CT scan will be done at 6 months in order to assess bone fusion.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02161016
Brief Title
A Clinical Study of Outcomes in Foot and Ankle Bone Grafting Using map3® Cellular Allogeneic Bone Graft
Official Title
A Radiographic and Clinical Outcomes Study Evaluating map3® Cellular Allogeneic Bone Graft in Patients Undergoing Bone Grafting in the Foot/Ankle
Study Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Terminated
Why Stopped
slow recruitment
Study Start Date
June 2014 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RTI Surgical
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Foot Deformities, Acquired, Disorder of Joint of Foot, Fracture of Foot, Deformity of Bone
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
map3 allogeneic bone graft
Arm Type
Other
Arm Description
Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells.
Intervention Type
Device
Intervention Name(s)
map3
Intervention Description
Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells.
Primary Outcome Measure Information:
Title
AOFAS Foot-and-Ankle Score
Description
The American Orthopaedic Foot and Ankle Society score returns an indexed score, from 0 - 100, to assess clinical outcomes following foot /ankle surgery.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
SF-36 Score
Description
The SF-36 is a survey for health and well-being.
Time Frame
24 months
Title
Foot Ankle Disability Index
Description
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.
Time Frame
24 months
Title
CT Scan
Description
A CT scan will be done at 6 months in order to assess bone fusion.
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Time to Full Weight-bearing
Description
This will be the time from the date of surgery until the patient has full, unassisted weight bearing, and will be measured in weeks.
Time Frame
up to 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Craig Radnay, MD
Organizational Affiliation
Saint Francis Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Saint Francis Hospital
City
Roslyn
State/Province
New York
ZIP/Postal Code
11576
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
21056860
Citation
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.
Results Reference
background
PubMed Identifier
22014833
Citation
Clements 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.
Results Reference
background
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A Clinical Study of Outcomes in Foot and Ankle Bone Grafting Using map3® Cellular Allogeneic Bone Graft
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