Musculotendinous Tissue Repair Unit and Reinforcement (MTURR)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University of Pittsburgh
Sponsor:
Collaborator:
Information provided by (Responsible Party):
J. Peter Rubin, MD, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01292876
First received: February 8, 2011
Last updated: June 23, 2014
Last verified: June 2014
  Purpose

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 will formally evaluate healing and return of function after an extracellular matrix device implantation in 40 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.


Condition Intervention
Traumatic Injury
Muscle Injury
Tendon Injury
Soft Tissue Injury
Extremity Injury
Device: Extracellular Matrix

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Musculotendinous Tissue Unit Repair and Reinforcement (MTURR) With the Use of Biologic Scaffolds for Patients Suffering From Severe Skeletal Muscle Injury

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Physical Therapy Evaluation [ Time Frame: Approximately 6 months post-operative ] [ Designated as safety issue: Yes ]
    The primary objective of the study is to assess mechanical strength and function in patients 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 patients.


Secondary Outcome Measures:
  • Pathology Evaluation [ Time Frame: Approximately 6 months post-operative ] [ Designated as safety issue: Yes ]
    The secondary objective is to examine the cellular properties of the biopsy tissue material in each subject for future correlation with clinical outcomes.


Estimated Enrollment: 40
Study Start Date: December 2010
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Extracellular Matrix
Implantation of Extracellular Matrix
Device: Extracellular Matrix
Extracellular Matrix

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 will formally evaluate healing and return of function after an extracellular matrix device implantation in 40 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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with the following characteristics will be eligible to participate in the study:

    • Age: 18 to 70 years of age and able to provide informed consent
    • Civilian, and current or former military personnel are eligible to participate
    • Have suffered injury resulting in a structural deficit of a minimum of 20% of the muscle group mass and a functional deficit of a minimum of 25% when compared to the contralateral limb; or if bilateral injury is present to extremities, the potential surgical extremity is to be compared against normal expected values of a sample population of similar age and gender, and evidence of remaining tendon and musculotendinous units that could be surgically repaired with sutures.
    • Injuries may encompass a single muscle belly or compartment. Whether an area is expected to be repaired by sutures will be determined from imaging studies and physical examination.
    • Have suffered traumatic injury within the last 18 months to the upper and/or lower extremity; Target of 18 months or less but subject's may be enrolled with injury outside this range if the principal investigator determines that there is viable muscle in the injured compartment determined by clinical exam and imaging studies.
    • Eligible for study procedures 3 months post injury with stability determined by the Principal Investigator and/ or MD Co-Investigator
    • Willing and able to comply with follow up examinations, radiographic studies, physical therapy, muscle biopsy and laboratory tests.

Exclusion Criteria:

  • Patients with the following characteristics will be excluded from participating in the study:

    • Inability to provide informed consent
    • Poor nutrition (demonstrated by abnormal lab range for serum Albumin and Pre-Albumin values)
    • Chronic disease such as congestive heart failure, liver disease, renal disease, or diabetes
    • Active and unstable disease state or infection anywhere in the body per MD's evaluation and determination (demonstrated by stated or medical record history and abnormal lab range for CBC with Differential and Platelet, and chemistry panel values)
    • Known coagulopathy (demonstrated by stated or medical record history of diagnosis)
    • Pregnancy (demonstrated by a positive result of a urine pregnancy test)
    • Diagnosis of cancer within last 12 months and /or actively receiving chemotherapy or radiation treatment
    • Axis I diagnosis DSM-IV (e.g., Schizophrenia, Bipolar Disorder). Subjects who are found to be stable on medication and receive psychiatric clearance could be eligible for study participation per the Physician's discretion
    • Subjects with complete muscle/tendon gaps greater than 5 cm that are obvious on imaging studies and are unlikely to be reasonably repaired with sutures and reinforcement, and will be excluded.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01292876

Locations
United States, Maryland
Walter Reed National Military Medical Center (WRNMMC) Recruiting
Bethesda, Maryland, United States, 20889
Contact: Kelly A Hummer, R.N, BSN    703-408-6273    kelly.a.hummer.ctr@health.mil   
Principal Investigator: Mark E Fleming, MC, USN         
United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Jenelle Mock, BSN, CCRC    412-864-2587    restore@upmc.edu   
Principal Investigator: Joseph P Rubin, M.D.         
Sub-Investigator: Stephen F Badylak, DVM, PhD, MD         
Sub-Investigator: Michael Boninger, MD         
Sub-Investigator: Patsy Simon, RN, BS         
Sub-Investigator: Fabrisia Ambrosio, MPT         
Sub-Investigator: Elke Brown, MD         
Sub-Investigator: Spencer A Brown, PhD         
Sub-Investigator: Jenelle Mock, RN, BSN         
Sub-Investigator: Kristen Stearns, PhD         
Sub-Investigator: Wendy Wakefield, CRNP         
Sub-Investigator: Ernest Manders, MD         
Sub-Investigator: Tahsin Oguz Acarturk, MD         
Sub-Investigator: Jeffrey Gusenoff, MD         
Sub-Investigator: Allyson LaCovey, BS         
Sub-Investigator: Jenelle Mock, BSN, CCRC         
Sub-Investigator: Mara Yerk, BS         
Sub-Investigator: Carroll Lee, BSN         
Sub-Investigator: Ryan Mitchell, MD         
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Jenelle Mock    412-864-2587    restore@upmc.edu   
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: J. Peter Rubin, MD University of Pittsburgh
  More Information

Publications:

Responsible Party: J. Peter Rubin, MD, Prinicipal Investigator, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01292876     History of Changes
Other Study ID Numbers: PRO10010500
Study First Received: February 8, 2011
Last Updated: June 23, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by University of Pittsburgh:
MTURR
ECM
Muscle Loss
Tendon
Tendon Repair
Muscle Repair
Soft Tissue Repair
Scaffold
Extracellular Matrix

Additional relevant MeSH terms:
Soft Tissue Injuries
Tendon Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on August 19, 2014