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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 : August 14, 2017
Sponsor:
Collaborator:
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
Enrollment 17
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Extracellular Matrix
Hide Arm/Group Description Overall number of participants for which baseline characteristics were measured for all baseline measures reported..
Period Title: Overall Study
Started 17
Completed 13
Not Completed 4
Reason Not Completed
Physician Decision             4
Arm/Group Title Extracellular Matrix
Hide Arm/Group Description

Implantation of Extracellular Matrix

Extracellular Matrix: Extracellular Matrix

Overall Number of Baseline Participants 13
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13 participants
35  (10.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
Female
2
  15.4%
Male
11
  84.6%
1.Primary Outcome
Title Percent Change From Baseline in the Rectified and Integrated EMG Signal of the Tibialis Anterior Muscle At 24 Weeks Post-Operative
Hide Description The physical therapy program was designed to promote activation of the dorsiflexor muscles on the operated side, through manual feedback during volitional contractions.
Time Frame approximately 24 weeks post-operative
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Extracellular Matrix
Hide Arm/Group Description:
Participants for which final characteristics and functional evaluations were measured for all measures reported.
Overall Number of Participants Analyzed 13
Mean (95% Confidence Interval)
Unit of Measure: % change
1333
(737 to 1930)
2.Secondary Outcome
Title Percentage of Participants With Remodeling Response Approximately 6 Months Post-operative
Hide Description 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.
Time Frame Approximately 6 months post-operative
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Demonstrated remodeling response; discrepancy from from those completed in the study (12 of 13) is result of 1 subject not undergoing pathological examination.
Arm/Group Title Extracellular Matrix
Hide Arm/Group Description:
Overall number of participants for which characteristics were measured for all measures reported..
Overall Number of Participants Analyzed 12
Measure Type: Number
Unit of Measure: percentage of participants remodeling
55
Time Frame pre-op (baseline), 6-8 weeks post-op, 10-12 weeks post-op, 24 weeks post-op
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Extracellular Matrix_Control Extracellular Matrix_Exp
Hide Arm/Group Description Control (prior to implantation of ECM) Experimental group; post implantation of ECM
All-Cause Mortality
Extracellular Matrix_Control Extracellular Matrix_Exp
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Extracellular Matrix_Control Extracellular Matrix_Exp
Affected / at Risk (%) Affected / at Risk (%)
Total   0/17 (0.00%)   0/17 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Extracellular Matrix_Control Extracellular Matrix_Exp
Affected / at Risk (%) Affected / at Risk (%)
Total   0/17 (0.00%)   0/17 (0.00%) 
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
Publications:
Responsible Party: J. Peter Rubin, MD, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01292876     History of Changes
Other Study ID Numbers: PRO10010500
First Submitted: February 8, 2011
First Posted: February 10, 2011
Results First Submitted: July 27, 2016
Results First Posted: August 14, 2017
Last Update Posted: August 14, 2017