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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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ClinicalTrials.gov Identifier: NCT02161016
Recruitment Status : Terminated (slow recruitment)
First Posted : June 11, 2014
Results First Posted : April 1, 2015
Last Update Posted : April 1, 2015
Sponsor:
Information provided by (Responsible Party):
RTI Surgical

Study Description
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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.

Condition or disease Intervention/treatment Phase
Foot Deformities, Acquired Disorder of Joint of Foot Fracture of Foot Deformity of Bone Device: map3 Phase 4

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Radiographic and Clinical Outcomes Study Evaluating map3® Cellular Allogeneic Bone Graft in Patients Undergoing Bone Grafting in the Foot/Ankle
Study Start Date : June 2014
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
map3 allogeneic bone graft
Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells.
 Device: map3
Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. SF-36 Score [ Time Frame: 24 months ]
    The SF-36 is a survey for health and well-being.

  2. Foot Ankle Disability Index [ Time Frame: 24 months ]
    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.

  3. CT Scan [ Time Frame: 6 months ]
    A CT scan will be done at 6 months in order to assess bone fusion.


Other Outcome Measures:
  1. Time to Full Weight-bearing [ Time Frame: up to 24 months ]
    This will be the time from the date of surgery until the patient has full, unassisted weight bearing, and will be measured in weeks.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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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): NCT02161016


Locations
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United States, New York
Saint Francis Hospital
Roslyn, New York, United States, 11576
Sponsors and Collaborators
RTI Surgical
Investigators
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Principal Investigator: Craig Radnay, MD Saint Francis Memorial Hospital
More Information
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Publications:

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Responsible Party: RTI Surgical
ClinicalTrials.gov Identifier: NCT02161016    
Other Study ID Numbers: map3-2014
First Posted: June 11, 2014    Key Record Dates
Results First Posted: April 1, 2015
Last Update Posted: April 1, 2015
Last Verified: February 2015
Additional relevant MeSH terms:
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Foot Deformities
Foot Deformities, Congenital
Joint Diseases
Foot Deformities, Acquired
Congenital Abnormalities
 Musculoskeletal Diseases
Lower Extremity Deformities, Congenital
Limb Deformities, Congenital
Musculoskeletal Abnormalities