Status:
WITHDRAWN
Musculotendinous Tissue Unit Repair and Reinforcement (MTURR) Coordinating Center
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
United States Naval Medical Center, Portsmouth
United States Naval Medical Center, San Diego
Conditions:
Traumatic Injury
Muscle Injury
Eligibility:
All Genders
18-70 years
Phase:
NA
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...
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 injuri...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01497678
Start Date
March 1 2013
End Date
November 1 2014
Last Update
October 21 2016
Active Locations (1)
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1
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213