Musculotendinous Tissue Repair Unit and Reinforcement (MTURR) (MTURR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01292876
Recruitment Status : Completed
First Posted : February 10, 2011
Results First Posted : August 14, 2017
Last Update Posted : August 14, 2017
United States Department of Defense
Information provided by (Responsible Party):
J. Peter Rubin, MD, University of Pittsburgh

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Traumatic Injury
Muscle Injury
Tendon Injury
Soft Tissue Injury
Extremity Injury
Intervention: Device: Extracellular Matrix

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
Extracellular Matrix Overall number of participants for which baseline characteristics were measured for all baseline measures reported..

Participant Flow:   Overall Study
    Extracellular Matrix
Physician Decision                4 

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
Extracellular Matrix

Implantation of Extracellular Matrix

Extracellular Matrix: Extracellular Matrix

Baseline Measures
   Extracellular Matrix 
Overall Participants Analyzed 
[Units: Participants]
[Units: Years]
Mean (Standard Deviation)
 35  (10.5) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
Female      2  15.4% 
Male      11  84.6% 

  Outcome Measures

1.  Primary:   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 ]

2.  Secondary:   Percentage of Participants With Remodeling Response Approximately 6 Months Post-operative   [ Time Frame: Approximately 6 months post-operative ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information