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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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

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.

Detailed Summary: 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.
Sponsor: RTI Surgical

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: RTI Surgical

Dates:
Date Received: June 6, 2014
Date Started: June 2014
Date Completion:
Last Updated: March 31, 2015
Last Verified: February 2015