A Clinical Study of Outcomes in Foot and Ankle Bone Grafting Using map3® Cellular Allogeneic Bone Graft

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Radiographic and Clinical Outcomes Study Evaluating map3® Cellular Allogeneic Bone Graft in Patients Undergoing Bone Grafting in the Foot/Ankle

Conditions
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Disorder of Joint of Foot, Foot Deformities, Acquired, Fracture of Foot, Deformity of Bone

Intervention / Treatment
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* Device: map3


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: map3 allogeneic bone graft<br>Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells. | Device: map3<br>* Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SF-36 Score | The SF-36 is a survey for health and well-being. | 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. | 24 months | 
| CT Scan | A CT scan will be done at 6 months in order to assess bone fusion. | 6 months |