Musculotendinous Tissue Repair Unit and Reinforcement (MTURR)
Condition: Traumatic Injury; Muscle Injury; Tendon Injury; Soft Tissue Injury; Extremity Injury
MeSH terms: Wounds and Injuries; Tendon Injuries; Soft Tissue Injuries
Study type: Interventional

Summary: 
      The objective of the study is to assess mechanical strength and function in subjects
      undergoing Musculotendinous Tissue Unit Repair and Reinforcement (MTURR) with the use of
      biologic scaffolds for the restoration of both mechanical strength and function in these
      subjects. This study formally evaluated healing and return of function after an extracellular
      matrix device implantation in 17 male and female subjects participating at the University of
      Pittsburgh under the Department of Plastic and Reconstructive Surgery who suffer from injury
      with loss of skeletal muscle tissue.
    

Detailed description: 
      Loss of musculotendinous tissue as a result of trauma inevitably leads to severe morbidity
      for the subject and surgical challenges for the caregiver. The reconstruction of tissue
      following such injuries is often not possible and surgical options are extremely limited.
      Amputation of the affected limb is not an uncommon outcome. Free muscle grafts, pedicle
      grafts, and the use of prosthetic materials have all been attempted when primary repair is
      not possible due to loss of tissue domain. The results of such efforts are typically
      disheartening. If autologous grafts are used, donor site morbidity compounds the post
      surgical problems with resultant diminished quality of life. Stated differently, the existing
      treatment options for treatment of the loss of large amounts of skeletal muscle tissue with
      scarring are extremely limited because the existing tendon structures are damaged and lack
      strength. A Repair and Reinforcement approach with a biocompatible device would represent a
      paradigm shift in the treatment of traumatic tissue injury. This approach involves releasing
      scar tissue that constricts movement of the existing tendon, repairing damaged tendon and
      musculotendinous units with suture repair, and reinforcing the repair with a biologic
      scaffold material. The biologic scaffold is composed of animal derived collagen and the
      approved by the FDA as devices for reinforcement of soft tissues repaired by sutures or
      suture anchors, during tendon repair surgery." Additionally, as listed in the FDA 510k
      approval, these devices" provide a remodelable scaffold that is replaced by the subject's own
      soft tissues." These biologic materials fall into a category of implantable devices known as
      extracellular matrix (ECM) because they are composed of proteins that surround the cellular
      elements in mammals. No living cells are found in these ECM implantable devices. ECM devices
      are made by many commercial manufacturers and have been used for a variety of reconstructive
      surgical procedures for years. Because the ECM implant becomes populated with subject cells
      and blood vessels, the repair may be stronger and the new tissue growing within the device
      could possibly contribute to improved function by augmenting the tendon structure and
      allowing ingrowth of adjacent muscle fibers. The objective of the study is to assess
      mechanical strength and function in subjects undergoing Musculotendinous Tissue Unit Repair
      and Reinforcement (MTURR) with the use of biologic scaffolds for the restoration of both
      mechanical strength and function in these subjects. This study evaluated healing and return
      of function after an extracellular matrix device implantation in 17 male and female subjects
      participating at the University of Pittsburgh under the Department of Plastic Surgery who
      suffer from injury with loss of skeletal muscle tissue.
    

Intervention name(s): Extracellular Matrix
Intervention type(s): Device
Intervention description(s): Extracellular Matrix
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: MTURR; ECM; Muscle Loss; Tendon; Tendon Repair; Muscle Repair; Soft Tissue Repair; Scaffold; Extracellular Matrix