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

NCT05017701 | Terminated Results

• 1 other identifier: CHEL0001
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this research study is to gather data regarding the feasibility of the Bridge system for the management of pain following total hip arthroplasty (THA).

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• Change in Total Opioid Consumption Between Active and Sham Arms.

  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.

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

Secondary Outcomes (4)

• Change in Pain Between Active and Sham Arms as Measured Using the Numeric Rating Scale.

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

• Change in Postoperative Nausea Between Active and Sham Arms as Measured Using a Postoperative Nausea and Vomiting Rating Scale.

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

• Change in Functional Recovery Between Active and Sham Arms Assessed Using the Timed Up and Go (TUG) Assessment Collected on Post-Op Day 30

  Day of surgery to post-operative day 30.

• Change in Functional Recovery Between Active and Sham Arms Assessed Using the 12-Item Short Form Survey (SF-12) Collected on Post-Op Day 30

  Day of surgery to post-operative day 30.

Study Arms (2)

Bridge device

EXPERIMENTAL

The active Bridge device delivers electrical stimulation to the cranial and occipital nerves.

Device: Bridge device

Sham device

SHAM COMPARATOR

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

Device: Sham device

Interventions

Bridge device 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.

Bridge device

Sham device 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is 18 years of age or older
• Subject scheduled for elective primary unilateral total hip arthroplasty (THA)
• Subject opioid use is less than 60 milligram morphine equivalent for the last 30 days
• Subject has given written informed consent to participate in the study

You may not qualify if:

• Subjects who are pregnant or breastfeeding
• Subjects with cardiac pacemakers or other implanted devices (e.g. vagal nerve simulators), hemophilia or psoriasis vulgaris
• Subjects with a history of active depression, anxiety or catastrophizing
• Subjects with active alcoholism or drug abuse
• Subjects with severe chronic pain condition that requires daily preoperative opioid dependence
• Subjects deemed not suitable for the study at the discretion of the principal investigator
• Subjects who are concurrently participating in any other research study

Sponsors & Collaborators

• Masimo Corporation: lead

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15232, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Results Point of Contact

• Title: Chelsea Frank
• Organization: Masimo Corporation

clinicalresearchdept@masimo.com

949-297-7000

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2021
• First Posted: August 24, 2021
• Study Start: April 26, 2022
• Primary Completion: November 19, 2022
• Study Completion: May 24, 2023
• Last Updated: October 21, 2025
• Results First Posted: October 21, 2025

Record last verified: 2025-10

Locations

US (1)