Trial Outcomes & Findings for Thumb vs Great Toe Recovery (NCT NCT04312256)

Last Updated: 2024-06-04

Results Overview

The amount of time before initial muscle relaxation is recorded via neurostimulation with the Tetragraph device. As measure in seconds.

Recruitment status

COMPLETED

Study phase

Target enrollment

81 participants

Primary outcome timeframe

Up to 1 hour postoperatively

Results posted on

2024-06-04

Participant Flow

Participant milestones

Participant milestones
Measure	Dominant Hand and Great Toe Subjects who underwent an elective surgical procedure had TetraGraph device lead placement on the dominant hand and great toe. TetraGraph: FDA approved neuromuscular transmission monitor capable of measuring the depth of neuromuscular block in anesthetized patients who received neuromuscular blocking agents. TetraGraph uses EMG to measure the muscle action potentials that are generated in response to electrical neurostimulation via skin (ECG) electrodes.
Overall Study STARTED	81
Overall Study COMPLETED	81
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Thumb vs Great Toe Recovery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dominant Hand and Great Toe n=81 Participants Subjects who underwent an elective surgical procedure had TetraGraph device lead placement on the dominant hand and great toe. TetraGraph: FDA approved neuromuscular transmission monitor capable of measuring the depth of neuromuscular block in anesthetized patients who received neuromuscular blocking agents. TetraGraph uses EMG to measure the muscle action potentials that are generated in response to electrical neurostimulation via skin (ECG) electrodes.
Age, Continuous	55.2 years STANDARD_DEVIATION 13.3 • n=5 Participants
Sex: Female, Male Female	44 Participants n=5 Participants
Sex: Female, Male Male	37 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	73 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants
Race (NIH/OMB) White	73 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants
Region of Enrollment United States	81 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 1 hour postoperatively

The amount of time before initial muscle relaxation is recorded via neurostimulation with the Tetragraph device. As measure in seconds.

Outcome measures

Outcome measures
Measure	Flexor Hallucis Brevis (Great Toe) n=81 Participants TetraGraph monitoring flexor hallucis brevis (great toe) muscle for all subjects.	Adductor Pollicis (Thumb) n=81 Participants TetraGraph monitoring adductor pollicis (thumb) muscle for all subjects.
Onset Time of Muscle Relaxation for Flexor Hallucis Brevis (Great Toe) and Adductor Pollicis (Thumb) Muscles	180.0 seconds Interval 0.0 to 540.0	180.0 seconds Interval 0.0 to 840.0

PRIMARY outcome

Timeframe: Up to 1 hour postoperatively

Population: Data was not collected nor analyzed in18 subjects great toes. Data was not collected nor analyzed in 13 subjects thumbs.

The amount of time after muscle neurostimulation with the Tetragraph device completion to muscle full recovery. As measure in seconds.

Outcome measures

Outcome measures
Measure	Flexor Hallucis Brevis (Great Toe) n=63 Participants TetraGraph monitoring flexor hallucis brevis (great toe) muscle for all subjects.	Adductor Pollicis (Thumb) n=68 Participants TetraGraph monitoring adductor pollicis (thumb) muscle for all subjects.
Recover Time for Flexor Hallucis Brevis (Great Toe) and Adductor Pollicis (Thumb) Muscles	180 seconds Interval 0.0 to 1020.0	180 seconds Interval 0.0 to 660.0

SECONDARY outcome

Timeframe: Up to 1 hour postoperatively

The amount of time from reversal agent administered to initial muscle relaxation increase recorded via neurostimulation with the Tetragraph device. As measure in seconds.

Outcome measures

Outcome measures
Measure	Flexor Hallucis Brevis (Great Toe) n=81 Participants TetraGraph monitoring flexor hallucis brevis (great toe) muscle for all subjects.	Adductor Pollicis (Thumb) n=81 Participants TetraGraph monitoring adductor pollicis (thumb) muscle for all subjects.
Onset Time of Reversal Agent Administered for Flexor Hallucis Brevis (Great Toe) and Adductor Pollicis (Thumb) Muscles	180.0 seconds Interval 0.0 to 540.0	180.0 seconds Interval 0.0 to 840.0

SECONDARY outcome

Timeframe: Up to 1 hour postoperatively

Population: Data was not collected nor analyzed in 18 subjects great toes. Data was not collected nor analyzed in 13 subjects thumbs.

The amount of time after reversal agent administered to muscle full recovery recorded via neurostimulation with the Tetragraph device. As measure in seconds.

Outcome measures

Outcome measures
Measure	Flexor Hallucis Brevis (Great Toe) n=63 Participants TetraGraph monitoring flexor hallucis brevis (great toe) muscle for all subjects.	Adductor Pollicis (Thumb) n=68 Participants TetraGraph monitoring adductor pollicis (thumb) muscle for all subjects.
Recover Time of Reversal Agent Administered for Flexor Hallucis Brevis (Great Toe) and Adductor Pollicis (Thumb) Muscles	180.0 seconds Interval 0.0 to 1020.0	180.0 seconds Interval 0.0 to 660.0

Adverse Events

Dominant Hand and Great Toe

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

J. Ross Renew, M.D.

Mayo Clinic

Phone: 904-956-3328

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place