Trial Outcomes & Findings for Feasibility of Bridge for Post-Operative Pain Management in Hip Arthroplasty (NCT NCT05017701)

Last Updated: 2025-10-21

Results Overview

The sample size is well below the threshold needed to reliably assess outcomes and perform statistical comparisons. As a result, we have provided the raw data for comparison of opioid consumption between the two groups.

Recruitment status

TERMINATED

Target enrollment

5 participants

Primary outcome timeframe

Day of surgery to Day 5 (120 hours) post-op

Results posted on

2025-10-21

Participant Flow

Participant milestones

Participant milestones
Measure	Bridge Device The active Bridge device delivers electrical stimulation to the cranial and occipital nerves. Bridge device: Bridge is a percutaneous nerve field stimulation device which uses alternating currents of stimulation over a large field and with higher voltage in order to influence central pain areas.	Sham Device The sham device has the same appearance and will require the same placement technique as the Bridge (active) device but will not deliver electrical impulses Sham device: The sham device has the same appearance and will require the same placement technique as the Bridge (active) device but will not deliver electrical impulses.
Overall Study STARTED	2	3
Overall Study COMPLETED	2	3
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Feasibility of Bridge for Post-Operative Pain Management in Hip Arthroplasty

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bridge Device n=2 Participants The active Bridge device delivers electrical stimulation to the cranial and occipital nerves. Bridge device: Bridge is a percutaneous nerve field stimulation device which uses alternating currents of stimulation over a large field and with higher voltage in order to influence central pain areas.	Sham Device n=3 Participants The sham device has the same appearance and will require the same placement technique as the Bridge (active) device but will not deliver electrical impulses Sham device: The sham device has the same appearance and will require the same placement technique as the Bridge (active) device but will not deliver electrical impulses.	Total n=5 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants	3 participants n=7 Participants	5 participants n=5 Participants

PRIMARY outcome

Timeframe: Day of surgery to Day 5 (120 hours) post-op

Population: The study was terminated prematurely due to sponsor decision, with no clinical rationale for the termination. This was a feasibility study and the test device was deemed "end-of-life" by the manufacturer. Only 5 subjects were enrolled out of the 60 anticipated -2 with active devices and 3 with sham devices. All available demographic and outcome measure data from the limited sample size have been reported. Further data reporting would be statistically inappropriate due to the sample size.

Outcome measures

Outcome measures
Measure	Bridge Device n=2 Participants The active Bridge device delivers electrical stimulation to the cranial and occipital nerves. Bridge device: Bridge is a percutaneous nerve field stimulation device which uses alternating currents of stimulation over a large field and with higher voltage in order to influence central pain areas.	Sham Device n=3 Participants The sham device has the same appearance and will require the same placement technique as the Bridge (active) device but will not deliver electrical impulses Sham device: The sham device has the same appearance and will require the same placement technique as the Bridge (active) device but will not deliver electrical impulses.	Subject 3 - Sham Device The sham device has the same appearance and will require the same placement technique as the Bridge (active) device but will not deliver electrical impulses Sham device: The sham device has the same appearance and will require the same placement technique as the Bridge (active) device but will not deliver electrical impulses.	Subject 4 - Sham Device The sham device has the same appearance and will require the same placement technique as the Bridge (active) device but will not deliver electrical impulses Sham device: The sham device has the same appearance and will require the same placement technique as the Bridge (active) device but will not deliver electrical impulses.	Subject 5 - Sham Device The sham device has the same appearance and will require the same placement technique as the Bridge (active) device but will not deliver electrical impulses Sham device: The sham device has the same appearance and will require the same placement technique as the Bridge (active) device but will not deliver electrical impulses.
Change in Total Opioid Consumption Between Active and Sham Arms. Oxycodone 5mg	1 doses	33 doses	—	—	—
Change in Total Opioid Consumption Between Active and Sham Arms. Tramadol 50mg	0 doses	5 doses	—	—	—
Change in Total Opioid Consumption Between Active and Sham Arms. Meloxicam 15mg	0 doses	7 doses	—	—	—

SECONDARY outcome

Timeframe: Day of surgery to Day 5 (120 hours) post-op

Population: The study was terminated prematurely due to sponsor decision, with no clinical rationale for the termination. This was a feasibility study and the test device was deemed "end-of-life" by the manufacturer. Only 5 subjects were enrolled out of the 60 anticipated -2 with active devices and 3 with sham devices. All available demographic and outcome measure data from the limited sample have been reported. Further data reporting would be statistically inappropriate due to the sample size.

Pain scores using a numerical scale will be collected at rest and movement and will be obtained prior to surgery, in the recovery room, prior to leaving the recovery room, every 6 hours during the first 24 hrs, and at 48, 72, 96 and 120 hours post-operatively. Subjects will use a 0-10 numeric scale (0 indicating no pain and 10 indicating extreme pain).

Outcome measures

Outcome measures
Measure	Bridge Device n=1 Participants The active Bridge device delivers electrical stimulation to the cranial and occipital nerves. Bridge device: Bridge is a percutaneous nerve field stimulation device which uses alternating currents of stimulation over a large field and with higher voltage in order to influence central pain areas.	Sham Device n=1 Participants The sham device has the same appearance and will require the same placement technique as the Bridge (active) device but will not deliver electrical impulses Sham device: The sham device has the same appearance and will require the same placement technique as the Bridge (active) device but will not deliver electrical impulses.	Subject 3 - Sham Device n=1 Participants The sham device has the same appearance and will require the same placement technique as the Bridge (active) device but will not deliver electrical impulses Sham device: The sham device has the same appearance and will require the same placement technique as the Bridge (active) device but will not deliver electrical impulses.	Subject 4 - Sham Device n=1 Participants The sham device has the same appearance and will require the same placement technique as the Bridge (active) device but will not deliver electrical impulses Sham device: The sham device has the same appearance and will require the same placement technique as the Bridge (active) device but will not deliver electrical impulses.	Subject 5 - Sham Device n=1 Participants The sham device has the same appearance and will require the same placement technique as the Bridge (active) device but will not deliver electrical impulses Sham device: The sham device has the same appearance and will require the same placement technique as the Bridge (active) device but will not deliver electrical impulses.
Change in Pain Between Active and Sham Arms as Measured Using the Numeric Rating Scale. 6 hours post-op	9 score on a scale	1 score on a scale	7 score on a scale	5 score on a scale	5 score on a scale
Change in Pain Between Active and Sham Arms as Measured Using the Numeric Rating Scale. 12 hours post-op	7 score on a scale	1 score on a scale	7 score on a scale	4 score on a scale	8 score on a scale
Change in Pain Between Active and Sham Arms as Measured Using the Numeric Rating Scale. 18 hours post-op	7 score on a scale	2 score on a scale	7 score on a scale	2 score on a scale	6 score on a scale
Change in Pain Between Active and Sham Arms as Measured Using the Numeric Rating Scale. Day 1 (24 hours) post-op	8 score on a scale	0 score on a scale	6 score on a scale	1 score on a scale	6 score on a scale
Change in Pain Between Active and Sham Arms as Measured Using the Numeric Rating Scale. Day 2 (48 hours) post-op	4 score on a scale	1 score on a scale	4 score on a scale	4 score on a scale	5 score on a scale
Change in Pain Between Active and Sham Arms as Measured Using the Numeric Rating Scale. Day 5 (120 hours) post-op	4 score on a scale	1 score on a scale	3 score on a scale	3 score on a scale	3 score on a scale
Change in Pain Between Active and Sham Arms as Measured Using the Numeric Rating Scale. Day 3 (72 hours) post-op	4 score on a scale	1 score on a scale	5 score on a scale	3 score on a scale	4 score on a scale
Change in Pain Between Active and Sham Arms as Measured Using the Numeric Rating Scale. Day 4 (96 hours) post-op	3 score on a scale	4 score on a scale	5 score on a scale	2 score on a scale	3 score on a scale

SECONDARY outcome

Timeframe: Day of surgery to Day 5 (120 hours) post-op

Population: The study was terminated prematurely due to sponsor decision, with no clinical rationale for the termination. This was a feasibility study and the test device was deemed "end-of-life" by the manufacturer. Only 5 subjects were enrolled out of the 60 anticipated -2 with active devices and 3 with sham devices. All available demographic and outcome measure data from the limited sample have been reported. Further data reporting would be statistically inappropriate due to the sample size.

Postoperative nausea and vomiting will be evaluated from immediately after surgery through postoperative day 5, using a 0-10 scale (0 indicating no nausea and 10 indicating extreme nausea).

Outcome measures

Outcome measures
Measure	Bridge Device n=1 Participants The active Bridge device delivers electrical stimulation to the cranial and occipital nerves. Bridge device: Bridge is a percutaneous nerve field stimulation device which uses alternating currents of stimulation over a large field and with higher voltage in order to influence central pain areas.	Sham Device n=1 Participants The sham device has the same appearance and will require the same placement technique as the Bridge (active) device but will not deliver electrical impulses Sham device: The sham device has the same appearance and will require the same placement technique as the Bridge (active) device but will not deliver electrical impulses.	Subject 3 - Sham Device n=1 Participants The sham device has the same appearance and will require the same placement technique as the Bridge (active) device but will not deliver electrical impulses Sham device: The sham device has the same appearance and will require the same placement technique as the Bridge (active) device but will not deliver electrical impulses.	Subject 4 - Sham Device n=1 Participants The sham device has the same appearance and will require the same placement technique as the Bridge (active) device but will not deliver electrical impulses Sham device: The sham device has the same appearance and will require the same placement technique as the Bridge (active) device but will not deliver electrical impulses.	Subject 5 - Sham Device n=1 Participants The sham device has the same appearance and will require the same placement technique as the Bridge (active) device but will not deliver electrical impulses Sham device: The sham device has the same appearance and will require the same placement technique as the Bridge (active) device but will not deliver electrical impulses.
Change in Postoperative Nausea Between Active and Sham Arms as Measured Using a Postoperative Nausea and Vomiting Rating Scale. 6 hours post-op	0 score on a scale	0 score on a scale	0 score on a scale	0 score on a scale	0 score on a scale
Change in Postoperative Nausea Between Active and Sham Arms as Measured Using a Postoperative Nausea and Vomiting Rating Scale. 18 hours post-op	0 score on a scale	0 score on a scale	0 score on a scale	0 score on a scale	0 score on a scale
Change in Postoperative Nausea Between Active and Sham Arms as Measured Using a Postoperative Nausea and Vomiting Rating Scale. Day 1 (24 hours) post-op	0 score on a scale	0 score on a scale	3 score on a scale	0 score on a scale	0 score on a scale
Change in Postoperative Nausea Between Active and Sham Arms as Measured Using a Postoperative Nausea and Vomiting Rating Scale. Day 4 (96 hours) post-op	0 score on a scale	0 score on a scale	0 score on a scale	0 score on a scale	0 score on a scale
Change in Postoperative Nausea Between Active and Sham Arms as Measured Using a Postoperative Nausea and Vomiting Rating Scale. Day 5 (120 hours) post-op	0 score on a scale	0 score on a scale	0 score on a scale	0 score on a scale	0 score on a scale
Change in Postoperative Nausea Between Active and Sham Arms as Measured Using a Postoperative Nausea and Vomiting Rating Scale. 12 hours post-op	0 score on a scale	0 score on a scale	0 score on a scale	0 score on a scale	0 score on a scale
Change in Postoperative Nausea Between Active and Sham Arms as Measured Using a Postoperative Nausea and Vomiting Rating Scale. Day 2 (48 hours) post-op	0 score on a scale	0 score on a scale	0 score on a scale	0 score on a scale	0 score on a scale
Change in Postoperative Nausea Between Active and Sham Arms as Measured Using a Postoperative Nausea and Vomiting Rating Scale. Day 3 (72 hours) post-op	0 score on a scale	0 score on a scale	0 score on a scale	0 score on a scale	0 score on a scale

SECONDARY outcome

Timeframe: Day of surgery to post-operative day 30.

Population: No data was collected for this outcome measure. The study was terminated prematurely due to sponsor decision, with no clinical rationale for the termination. This was a feasibility study and the test device was deemed "end-of-life" by the manufacturer. Only 5 subjects were enrolled out of the 60 anticipated -2 with active devices and 3 with sham devices. All available demographic and outcome measure data from the limited sample have been reported.

Functional recovery will be assessed daily from day of surgery to post-op day 5, using the Timed Up and Go assessment to assess mobility.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day of surgery to post-operative day 30.

Subjects will also complete the 12-Item Short Form Survey (SF-12) on Post-Op day 30 to evaluate quality of recovery.

Outcome measures

Outcome data not reported

Adverse Events

Bridge Device

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sham Device

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

Chelsea Frank

Masimo Corporation

Phone: 949-297-7000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60