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

March 31, 2015 updated by: RTI Surgical

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Roslyn, New York, United States, 11576
        • Saint Francis Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
SF-36 Score
Time Frame: 24 months
The SF-36 is a survey for health and well-being.
24 months
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.
24 months
CT Scan
Time Frame: 6 months
A CT scan will be done at 6 months in order to assess bone fusion.
6 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
RTI Surgical

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Craig Radnay, MD, Saint Francis Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 6, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 11, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 1, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • map3-2014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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