Instructive Biologic Scaffold for Functional Tissue Regeneration Following Trauma to the Extremities
Technical Report,30 Sep 2012,31 Aug 2017
The Geneva Foundation Tacoma United States
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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.
- Medicine and Medical Research