Musculotendinous Tissue Unit Repair and Reinforcement (MTURR) Coordinating Center

NCT01497678 | Withdrawn DMC

• 1 other identifier: PRO11050209
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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 will formally evaluate healing and return of function after an extracellular matrix device implantation in 40 male and female subjects participating at 4-5 military sites who suffer from injury with loss of skeletal muscle tissue. The University of Pittsburgh under the Department of Plastic and Reconstructive Surgery is the Coordinating Center for this multi-site study.

Conditions

Traumatic Injury; Muscle Injury; Tendon Injury; Soft Tissue Injury; Extremity Injury

Keywords

MTURR; ECM; Muscle Loss; Tendon; Tendon Repair; Muscle Repair; Soft Tissue Repair; Scaffold; Extracellular Matrix

Outcome Measures

Primary Outcomes (1)

• Mechanical strength and function

  The primary objective of the study is to assess mechanical strength and function of surgical extremity 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. Physical therapy evaluations of strength and active/passive range of motion and self-reported measures of ability to perform activities of daily living.

  Approximately 6 months post-operative

Secondary Outcomes (1)

• Pathology Evaluation

  Approximately 6 months post-operative

Study Arms (1)

Extracellular Matrix

OTHER

Implantation of Extracellular Matrix

Device: Extracellular Matrix

Interventions

Extracellular Matrix DEVICE

Extracellular Matrix

Extracellular Matrix

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pittsburgh: lead
• United States Naval Medical Center, Portsmouth: collaborator
• United States Naval Medical Center, San Diego: collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (9)

• Valentin JE, Badylak JS, McCabe GP, Badylak SF. Extracellular matrix bioscaffolds for orthopaedic applications. A comparative histologic study. J Bone Joint Surg Am. 2006 Dec;88(12):2673-86. doi: 10.2106/JBJS.E.01008.

  PMID: 17142418 BACKGROUND

• Beattie AJ, Gilbert TW, Guyot JP, Yates AJ, Badylak SF. Chemoattraction of progenitor cells by remodeling extracellular matrix scaffolds. Tissue Eng Part A. 2009 May;15(5):1119-25. doi: 10.1089/ten.tea.2008.0162.

  PMID: 18837648 BACKGROUND

• Holcomb JB, Stansbury LG, Champion HR, Wade C, Bellamy RF. Understanding combat casualty care statistics. J Trauma. 2006 Feb;60(2):397-401. doi: 10.1097/01.ta.0000203581.75241.f1.

  PMID: 16508502 BACKGROUND

• Mazurek MT, Ficke JR. The scope of wounds encountered in casualties from the global war on terrorism: from the battlefield to the tertiary treatment facility. J Am Acad Orthop Surg. 2006;14(10 Spec No.):S18-23. doi: 10.5435/00124635-200600001-00005.

  PMID: 17003195 BACKGROUND

• Noe A. Extremity injury in war: a brief history. J Am Acad Orthop Surg. 2006;14(10 Spec No.):S1-6. doi: 10.5435/00124635-200600001-00002.

  PMID: 17003177 BACKGROUND

• Hostetler SG, Schwartz L, Shields BJ, Xiang H, Smith GA. Characteristics of pediatric traumatic amputations treated in hospital emergency departments: United States, 1990-2002. Pediatrics. 2005 Nov;116(5):e667-74. doi: 10.1542/peds.2004-2143.

  PMID: 16263981 BACKGROUND

• Crisan M, Yap S, Casteilla L, Chen CW, Corselli M, Park TS, Andriolo G, Sun B, Zheng B, Zhang L, Norotte C, Teng PN, Traas J, Schugar R, Deasy BM, Badylak S, Buhring HJ, Giacobino JP, Lazzari L, Huard J, Peault B. A perivascular origin for mesenchymal stem cells in multiple human organs. Cell Stem Cell. 2008 Sep 11;3(3):301-13. doi: 10.1016/j.stem.2008.07.003.

  PMID: 18786417 BACKGROUND

• Reing JE, Zhang L, Myers-Irvin J, Cordero KE, Freytes DO, Heber-Katz E, Bedelbaeva K, McIntosh D, Dewilde A, Braunhut SJ, Badylak SF. Degradation products of extracellular matrix affect cell migration and proliferation. Tissue Eng Part A. 2009 Mar;15(3):605-14. doi: 10.1089/ten.tea.2007.0425.

  PMID: 18652541 BACKGROUND

• Zantop T, Gilbert TW, Yoder MC, Badylak SF. Extracellular matrix scaffolds are repopulated by bone marrow-derived cells in a mouse model of achilles tendon reconstruction. J Orthop Res. 2006 Jun;24(6):1299-309. doi: 10.1002/jor.20071.

  PMID: 16649228 BACKGROUND

Related Links

• Musclotendinous Tissue Repair Unit and Reinforcement (MTURR)

MeSH Terms

Conditions

Wounds and Injuries; Tendon Injuries; Soft Tissue Injuries; Muscular Atrophy

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• J. Peter Rubin, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 9, 2011
• First Posted: December 22, 2011
• Study Start: March 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: October 21, 2016

Record last verified: 2016-10

Locations

US (1)