Trial Outcomes & Findings for Musculotendinous Tissue Repair Unit and Reinforcement (MTURR) (NCT NCT01292876)

NCT ID: NCT01292876

Last Updated: 2020-12-07

Results Overview

The physical therapy program was designed to promote activation of the dorsiflexor muscles on the operated side, through manual feedback during volitional contractions.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 17 participants
• Primary outcome timeframe: approximately 24 weeks post-operative
• Results posted on: 2020-12-07

Participant Flow

Participant milestones

Measure	Extracellular Matrix Overall number of participants for which baseline characteristics were measured for all baseline measures reported..
Overall Study STARTED	17
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Measure	Extracellular Matrix Overall number of participants for which baseline characteristics were measured for all baseline measures reported..
Overall Study Physician Decision	4

Baseline Characteristics

Musculotendinous Tissue Repair Unit and Reinforcement (MTURR)

Baseline characteristics by cohort

Measure	Extracellular Matrix n=13 Participants Implantation of Extracellular Matrix Extracellular Matrix: Extracellular Matrix
Age, Continuous	35 years STANDARD_DEVIATION 10.5 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Extracellular Matrix n=13 Participants Participants for which final characteristics and functional evaluations were measured for all measures reported.
Percent Change From Baseline in the Rectified and Integrated EMG Signal of the Tibialis Anterior Muscle At 24 Weeks Post-Operative	1333 % change Interval 737.0 to 1930.0

SECONDARY outcome

Timeframe: Approximately 6 months post-operative

Population: Demonstrated remodeling response; discrepancy from from those completed in the study (12 of 13) is result of 1 subject not undergoing pathological examination.

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.

Outcome measures

Measure	Extracellular Matrix n=12 Participants Participants for which final characteristics and functional evaluations were measured for all measures reported.
Percentage of Participants With Remodeling Response Approximately 6 Months Post-operative	55 percentage of participants remodeling

Adverse Events

Extracellular Matrix_Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Extracellular Matrix_Exp

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Maria Alexander, Office Manager

University of Pittsburgh

Phone: 412-624-5308

Email: alexanderm3@upmc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place