Ultrasound as Adjunct Therapy for Increasing Fusion Succe... | NCT00744861

NCT00744861

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Exogen 4000+	Active Comparator	Low intensity pulsed ultrasound (LIPUS) delivered via Exogen 4000+ (single transducer) device for a treatment duration of 20 minutes per fusion site per day.	Device: Exogen 4000+
Exogen 4000+ sham	Sham Comparator	Non-active sham device identical to Exogen 4000+ (single transducer); treatment duration of 20 minutes per fusion site per day	Device: Exogen 4000+ sham
Exospine	Active Comparator	Low intensity pulsed ultrasound delivered via Exospine device (dual transducers); treatment duration of 20 minutes per day	Device: Exospine
Exospine sham	Sham Comparator	Non-active sham device identical to Exospine (dual transducers); treatment duration of 20 minutes per day	Device: Exospine sham

Name	Type	Description	Arm Group Labels	Other Names
Exospine sham	Device	Inactive Exospine LIPUS device (dual transducers)	Exospine sham

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Posterolateral Fusion Success at the Treated Level	Fusion success at the treated level was defined as at least 2 of 3 independent blinded radiologists agree all 3 of the following criteria were met. Confirmation of bridging bone based on computed tomography (CT) evidence of a continuous bony connection between the transverse processes on both posterolateral sides, assessed using a numeric grading scale. No evidence of motion defined as <5° angulation based on flexion and extension radiographs. No evidence of translational movement defined as <3 mm difference based on flexion and extension radiographs.	12 months post treatment start

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Jeffrey Fischgrund, MD	Corewell Health East	Principal Investigator

IPD Sharing Statement Module

Arm/Group Information

ID	Title	Description
FG000	Exogen 4000+ Sham	Inactive LIPUS sham (single transducer)
FG001	Exogen 4000+	Active LIPUS device (single transducer)
FG002	Exospine	Active LIPUS device (dual transducers)
FG003	Exospine Sham	Inactive Exospine device (dual transducers)

Periods

Title

Milestones

Reasons Not Completed

Feasibility Stage 1

Type	Comment	Milestone Data
STARTED		FG0008 subjectsStage 1: Study phase to determine the feasibility of the study treatment and assessments FG00110 subjectsStage 1: Study phase to determine the feasibility of the study treatment and assessments FG0020 subjectsNo subjects enrolled in Stage 1/Feasibility study FG0030 subjectsNo subjects enrolled in Stage 1/Feasibility study
COMPLETED		FG0007 subjects FG0018 subjects FG0020 subjects FG0030 subjects
NOT COMPLETED		FG0001 subjects FG0012 subjects FG0020 subjects FG0030 subjects

Type	Comment	Reasons
Withdrawal by Subject		FG0001 subjects FG0011 subjects FG0020 subjects FG003

Pivotal Stage 2

Type	Comment	Milestone Data
STARTED		FG0000 subjectsNo subjects enrolled in Stage 2 pivotal study phase FG0010 subjectsNo subjects enrolled in Stage 2 pivotal study phase FG002154 subjectsStage 2 pivotal study phase assessed safety and effectiveness of LIPUS treatment via Exospine device FG003

Baseline Characteristics Module

ID	Title	Description
BG000	Exogen 4000+ Sham	Inactive LIPUS sham (single transducer)
BG001	Exogen 4000+	Active LIPUS device (single transducer)

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants With Posterolateral Fusion Success at the Treated Level

Fusion success at the treated level was defined as at least 2 of 3 independent blinded radiologists agree all 3 of the following criteria were met.

Confirmation of bridging bone based on computed tomography (CT) evidence of a continuous bony connection between the transverse processes on both posterolateral sides, assessed using a numeric grading scale.
No evidence of motion defined as <5° angulation based on flexion and extension radiographs.
No evidence of translational movement defined as <3 mm difference based on flexion and extension radiographs.

Full Analysis Set (FAS): all safety subjects with at least one fully adjudicated fusion assessment at the month 12 visit of assessment

Posted

Number

participants

12 months post treatment start

ID	Title	Description
OG000	Exospine Sham	Exospine Inactive: dual transducers

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Exogen 4000+ Sham	Stage 1 Feasibility: Exogen 4000+ sham, inactive single transducer

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA	Non-systematic Assessment

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Fall	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Manager Clinical Affairs	Bioventus LLC	1-800-396-4325

Condition Browse Module

ID	Term
D013122	Spinal Diseases
D001847	Bone Diseases
D009140	Musculoskeletal Diseases