Musculotendinous Tissue Repair Unit and Reinforcement (MTURR) (MTURR)
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ClinicalTrials.gov Identifier: NCT01292876 |
Recruitment Status :
Completed
First Posted : February 10, 2011
Results First Posted : August 14, 2017
Last Update Posted : December 7, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Traumatic Injury Muscle Injury Tendon Injury Soft Tissue Injury Extremity Injury | Device: Extracellular Matrix | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 17 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (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 |
Study Start Date : | December 2010 |
Actual Primary Completion Date : | May 2015 |
Actual Study Completion Date : | May 2015 |
Arm | Intervention/treatment |
---|---|
Extracellular Matrix
Implantation of Extracellular Matrix
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Device: Extracellular Matrix
Extracellular Matrix |
- Percent Change From Baseline in the Rectified and Integrated EMG Signal of the Tibialis Anterior Muscle At 24 Weeks Post-Operative [ Time Frame: approximately 24 weeks post-operative ]The physical therapy program was designed to promote activation of the dorsiflexor muscles on the operated side, through manual feedback during volitional contractions.
- Percentage of Participants With Remodeling Response Approximately 6 Months Post-operative [ Time Frame: Approximately 6 months post-operative ]The secondary objective is to examine the cellular properties of the biopsy tissue material in each subject for future correlation with clinical outcomes. Seven biopsy samples were collected and stained with Hematoxylin and eosin (H&E) and Masson's trichrome stain. Tissue was stained with antibodies against the progenitor cell markers CD146 and NG2 to show evidence of progenitor cell migration into the remodeling injury site.

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01292876
United States, Maryland | |
Walter Reed National Military Medical Center (WRNMMC) | |
Bethesda, Maryland, United States, 20889 | |
United States, Pennsylvania | |
University of Pittsburgh | |
Pittsburgh, Pennsylvania, United States, 15213 |
Principal Investigator: | J. Peter Rubin, MD | University of Pittsburgh |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | J. Peter Rubin, MD, Prinicipal Investigator, University of Pittsburgh |
ClinicalTrials.gov Identifier: | NCT01292876 |
Other Study ID Numbers: |
PRO10010500 |
First Posted: | February 10, 2011 Key Record Dates |
Results First Posted: | August 14, 2017 |
Last Update Posted: | December 7, 2020 |
Last Verified: | December 2020 |
MTURR ECM Muscle Loss Tendon Tendon Repair |
Muscle Repair Soft Tissue Repair Scaffold Extracellular Matrix |
Wounds and Injuries Tendon Injuries Soft Tissue Injuries |