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Ultrasound as Adjunct Therapy for Increasing Fusion Success After Lumbar Surgery

EXO-SPINE: A Prospective, Multi-center, Double-blind, Randomized, Placebo Controlled Pivotal Study of Ultrasound as Adjunctive Therapy for Increasing Posterolateral Fusion Success Following Single Level Posterior Instrumented Lumbar Surgery

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00744861
Acronym
EXO-SPINE
Enrollment
328
Registered
2008-09-01
Start date
2008-09-30
Completion date
2012-05-31
Last updated
2021-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lumbar Degenerative Disc Disease

Keywords

Lumbar Fusion, exospine, Exo-Spine, LIPUS, Exogen

Brief summary

Adjunct therapy for increasing posterolateral fusion success following single level posterior instrumented lumbar surgery.

Detailed description

The purpose of this study is to determine whether using active low intensity pulsed ultrasound as adjunct therapy following single level posterior instrumented lumbar surgery increases the posterolateral success rate when compared to inactive (placebo) therapy.

Interventions

DEVICEExospine sham

Inactive Exospine LIPUS device (dual transducers)

DEVICEExospine

Active Exospine LIPUS device (dual transducers)

DEVICEExogen 4000+

Active Exogen LIPUS device (single transducer)

DEVICEExogen 4000+ sham

Inactive Exogen 4000+ LIPUS device (single transducer)

Sponsors

Bioventus LLC
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 81 Years
Healthy volunteers
No

Inclusion criteria

* The subject has a documented diagnosis of degenerative disc disease with up to Grade I spondylolisthesis at the target level * Requires spinal fusion of a single level disc space (L2 to S1) with the use of local bone graft. * Requires a posterolateral fusion procedure with or without an interbody fusion procedure using a posterior approach * The subject has failed non-operative treatment lasting at least 6 months.

Exclusion criteria

* Requires spinal fusion at more than one lumbar level. * Is pregnant, is lactating or plans to become pregnant before discontinuation of study treatment

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants With Posterolateral Fusion Success at the Treated Level12 months post treatment startFusion 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. 1. 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. 2. No evidence of motion defined as \<5° angulation based on flexion and extension radiographs. 3. No evidence of translational movement defined as \<3 mm difference based on flexion and extension radiographs.

Participant flow

Recruitment details

Study conducted in 2 stages: Stage 1 was feasibility phase assessing study treatment and study assessments. LIPUS delivered via Exogen 4000+ device with a single transducer was used for this phase of the study Stage 2 was pivotal phase assessing safety and effectiveness. LIPUS delivered via Exospine device (dual transducers)

Participants by arm

ArmCount
Exogen 4000+ Sham
Inactive LIPUS sham (single transducer)
8
Exogen 4000+
Active LIPUS device (single transducer)
10
Exospine Sham
Inactive LIPUS device (dual transducer)
156
Exospine
Active LIPUS device (dual transducer)
154
Total328

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003
Feasibility Stage 1Pregnancy0100
Feasibility Stage 1Withdrawal by Subject1100
Pivotal Stage 2Adverse Event00611
Pivotal Stage 2Death0001
Pivotal Stage 2Lost to Follow-up001314
Pivotal Stage 2Physician Decision0031
Pivotal Stage 2Protocol Violation0001
Pivotal Stage 2Study Terminated by Sponsor006063
Pivotal Stage 2Withdrawal by Subject002014

Baseline characteristics

CharacteristicExogen 4000+ ShamExogen 4000+Exospine ShamExospineTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
2 Participants1 Participants61 Participants48 Participants112 Participants
Age, Categorical
Between 18 and 65 years
6 Participants9 Participants95 Participants106 Participants216 Participants
Age, Continuous53.8 years
STANDARD_DEVIATION 11.55
52.4 years
STANDARD_DEVIATION 14.39
58.30 years
STANDARD_DEVIATION 13.9
56.10 years
STANDARD_DEVIATION 13.57
57.20 years
STANDARD_DEVIATION 13.76
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants2 Participants0 Participants2 Participants
Race (NIH/OMB)
Asian
0 Participants2 Participants1 Participants0 Participants3 Participants
Race (NIH/OMB)
Black or African American
1 Participants2 Participants13 Participants15 Participants31 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants4 Participants1 Participants5 Participants
Race (NIH/OMB)
White
7 Participants6 Participants136 Participants138 Participants287 Participants
Sex: Female, Male
Female
3 Participants7 Participants95 Participants90 Participants195 Participants
Sex: Female, Male
Male
5 Participants3 Participants61 Participants64 Participants133 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —— / —
other
Total, other adverse events
5 / 87 / 1056 / 15659 / 154
serious
Total, serious adverse events
1 / 80 / 1023 / 15618 / 154

Outcome results

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. 1. 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. 2. No evidence of motion defined as \<5° angulation based on flexion and extension radiographs. 3. No evidence of translational movement defined as \<3 mm difference based on flexion and extension radiographs.

Time frame: 12 months post treatment start

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

ArmMeasureValue (NUMBER)
Exospine ShamNumber of Participants With Posterolateral Fusion Success at the Treated Level25 participants
Exospine ActiveNumber of Participants With Posterolateral Fusion Success at the Treated Level28 participants
p-value: 0.9905Cochran-Mantel-Haenszel

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026