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Trial record 2 of 2 for:    Musculotendinous Tissue Unit Repair

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

This study has been completed.
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
J. Peter Rubin, MD, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01292876
First received: February 8, 2011
Last updated: July 13, 2017
Last verified: July 2017
Results First Received: July 27, 2016  
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
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Extracellular Matrix Overall number of participants for which baseline characteristics were measured for all baseline measures reported..

Participant Flow:   Overall Study
    Extracellular Matrix
STARTED   17 
COMPLETED   13 
NOT COMPLETED   4 
Physician Decision                4 



  Baseline Characteristics
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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.
No text entered.

Reporting Groups
  Description
Extracellular Matrix

Implantation of Extracellular Matrix

Extracellular Matrix: Extracellular Matrix


Baseline Measures
   Extracellular Matrix 
Overall Participants Analyzed 
[Units: Participants]
 13 
Age 
[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
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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
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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
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Maria Alexander, Office Manager
Organization: University of Pittsburgh
phone: 412-624-5308
e-mail: alexanderm3@upmc.edu


Publications:


Responsible Party: J. Peter Rubin, MD, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01292876     History of Changes
Other Study ID Numbers: PRO10010500
Study First Received: February 8, 2011
Results First Received: July 27, 2016
Last Updated: July 13, 2017