Instructive Biologic Scaffold for Functional Tissue Regeneration Following Trauma to the Extremities

Abstract

Our hypothesis is that subjects who receive the SIS-ECM scaffold material will have significant new muscle growth and improvements in strength in the treated extremity. The proposed prospective, non-randomized, two-armed study in forty (40) subjects will establish the safety and effectiveness of a regenerative scaffold for the restoration of functional musculotendinous tissue, including the restoration of blood supply and innervation. Cohort 1 will include 20 subjects with upper extremity flexor and extensor traumatic, postoperative, or other avulsive VML. Cohort 2 will include 20 subjects with open femur fractures or soft tissue injury to the thigh resulting in VML. The primary endpoint will be changes in graft site muscle volume compared to baseline at 6 and 12 months as determined by imaging.

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Document Details

Document Type
Technical Report
Publication Date
Oct 01, 2016
Accession Number
AD1047611

Entities

People

  • Leon Nesti

Organizations

  • Geneva Foundation

Tags

Communities of Interest

  • Biomedical

DTIC Thesaurus Topics

  • Demographic Cohorts
  • Department Of Defense
  • Health Services
  • Lower Extremity
  • Materials
  • Medical Personnel
  • Military Medicine
  • Muscular Diseases
  • Personnel Management
  • Physical Therapy
  • Physicians
  • Plastic Surgery
  • Regenerative Medicine
  • Soft Tissues
  • Tissues
  • Upper Extremity
  • Wounds And Injuries

Fields of Study

  • Medicine

Readers

  • Exercise and Sports Science.
  • Trauma Surgery or Emergency Medicine.