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

NCT02161016 | Terminated Phase 4 Results

• 1 other identifier: map3-2014
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• SF-36 Score

  24 months

• Foot Ankle Disability Index

  24 months

• CT Scan

  6 months

Other Outcomes (1)

• Time to Full Weight-bearing

  up to 24 months

Study Arms (1)

map3 allogeneic bone graft

OTHER

Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells.

Device: map3

Interventions

map3 DEVICE

Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells.

map3 allogeneic bone graft

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• RTI Surgical: lead

Study Sites (1)

Saint Francis Hospital

Roslyn, New York, 11576, United States

Location

Related Publications (2)

• 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.

  PMID: 21056860 BACKGROUND

• 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.

  PMID: 22014833 BACKGROUND

MeSH Terms

Conditions

Foot Deformities, Acquired

Condition Hierarchy (Ancestors)

Foot Deformities; Musculoskeletal Diseases

Results Point of Contact

• Title: Robin Waite
• Organization: RTI Surgical

rwaite@rtix.com

386-418-8888

Study Officials

• Craig Radnay, MD

  Saint Francis Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2014
• First Posted: June 11, 2014
• Study Start: June 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: April 1, 2015
• Results First Posted: April 1, 2015

Record last verified: 2015-02

Locations

US (1)