- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02161016
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
Terminated
Intervention / Treatment
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
Interventional
Enrollment (Actual)
1
Phase
- 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
-
-
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
Ages Eligible for Study
16 years to 78 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 |
Intervention / Treatment |
---|---|
Other: map3 allogeneic bone graft
Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells.
|
Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells.
|
What is the study measuring?
Primary Outcome Measures
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
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
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
Investigators
- 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
- 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.
- 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.
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
June 1, 2014
Primary Completion (Actual)
January 1, 2015
Study Completion (Actual)
January 1, 2015
Study Registration Dates
First Submitted
June 6, 2014
First Submitted That Met QC Criteria
June 9, 2014
First Posted (Estimate)
June 11, 2014
Study Record Updates
Last Update Posted (Estimate)
April 1, 2015
Last Update Submitted That Met QC Criteria
March 31, 2015
Last Verified
February 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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.
Clinical Trials on Foot Deformities, Acquired
-
Mustafa Kemal UniversityRecruitingFlat Foot [Pes Planus] (Acquired), Unspecified FootTurkey
-
Abant Izzet Baysal UniversityCompletedFlat Foot [Pes Planus] (Acquired), Unspecified FootTurkey
-
Hacettepe UniversityEnrolling by invitationSpinal Curvatures | Flat Foot [Pes Planus] (Acquired), Left Foot | Flat Foot [Pes Planus] (Acquired), Right Foot | Flat Foot Acquired Bilateral (Pes Planus) | Pelvic ObliquityTurkey
-
Pamukkale UniversityCompletedFoot Deformities | Flatfoot | Foot; Deformity, Valgus, Congenital | Foot; Deformity, Valgus (Acquired)Turkey
-
Albert Einstein Healthcare NetworkCompleted
-
OrthoCarolina Research Institute, Inc.Stryker Trauma GmbHWithdrawnAdult Acquired FlatfootUnited States
-
Region SkaneRecruitingFlexible Flatfoot | Flat Foot | Acquired Adult Flatfoot DeformitySweden
-
Assiut UniversityRecruiting
-
Istituto Ortopedico RizzoliCompleted
-
Taipei Medical UniversityUnknown
Clinical Trials on map3
-
RTI SurgicalCompletedDegenerative Disc Disease | Spondylosis | SpondylolisthesisUnited States