Lumbar Degenerative Disc DiseaseEXO-SPINENCT00744861

Ultrasound as Adjunct Therapy for Increasing Fusion Success After Lumbar Surgery

A study testing Exospine and Exogen 4000+ in people with Lumbar Degenerative Disc Disease, run by Bioventus LLC.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

Adjunct therapy for increasing posterolateral fusion success following single level posterior instrumented lumbar surgery. Read more about this study

Who is it for?: Ages 18 to 81 years
Conditions the study is for: Lumbar Degenerative Disc Disease
What is being tested?: Exospine and Exogen 4000+
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 328 participants
Where: No sites listed yet
Study dates: Sep 2008to May 2012
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 81 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

About this study

Official title: 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

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

Read the 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.

Conditions: Lumbar Degenerative Disc Disease
Being tested: Exospine sham, Exospine, Exogen 4000+, Exogen 4000+ sham
Keywords: Lumbar Fusion, exospine, Exo-Spine, LIPUS, Exogen
Medical subject headings: Intervertebral Disc Degeneration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Exospine shamDevice
Inactive Exospine LIPUS device (dual transducers)
ExospineDevice
Active Exospine LIPUS device (dual transducers)
Exogen 4000+Device
Active Exogen LIPUS device (single transducer)
Exogen 4000+ shamDevice
Inactive Exogen 4000+ LIPUS device (single transducer)

Study groups in NCT00744861
Study group	Role	What they receive
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. Receives: 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 Receives: Device: Exogen 4000+ sham
Exospine	Active comparator	Low intensity pulsed ultrasound delivered via Exospine device (dual transducers); treatment duration of 20 minutes per day Receives: Device: Exospine
Exospine sham	Sham comparator	Non-active sham device identical to Exospine (dual transducers); treatment duration of 20 minutes per day Receives: Device: Exospine sham

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 12 months post treatment start

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2008May 2012

First posted1 Sep 2008 (estimated)
Study startSep 2008
Primary completionMay 2012
Study completionMay 2012

Why it stopped: Terminated following interim analysis

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Lumbar Degenerative Disc DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 328 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00744861
Sponsor's protocol ID: EX-SPINE0907
Acronym: EXO-SPINE
Status last verified: Mar 2021
First submitted: 29 Aug 2008
Last updated: 2 Apr 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Active, not recruiting
Post Marketing Study of MagnetOs Easypack Putty Standalone Compared to Demineralized Bone Matrix or Fibers Mixed With Autograft in Patients Undergoing Posterolateral Lumbar Fusion
Degenerative Disc Disease, Spine Fusion
Not yet recruitingObservational study
Relationship Between Disability, Flexibility, Back Muscles, and Thoracolumbar Fascia in Patients With Lumbar Disc Degeneration
Intervertebral Disc Degeneration
Active, not recruiting
ASCEND: A Clinical Trial to Evaluate the Safety and Effectiveness of VIA Disc NP, a Supplement for Degenerated Intervertebral Discs
Degenerative Disc Disease, Disc Degeneration
Not yet recruiting
Kore Fiber PLF Study
Degenerative Lumbar Spine Diseases, Lumbar Degenerative Disc Disease
Recruiting
MagnetOs Flex Matrix Compared to Trinity Elite Mixed With Local Autograft in Patients Undergoing up to Four-level Instrumented Posterolateral Fusion
Degenerative Disc Disease, Spine Fusion

All Lumbar Degenerative Disc Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT00744861
Acronym / sponsor ID: EXO-SPINE / EX-SPINE0907
Conditions: Lumbar Degenerative Disc Disease
Keywords: Lumbar Fusion, exospine, Exo-Spine, LIPUS, Exogen
Study type: Interventional
Recruitment status: TerminatedReason stopped: Terminated following interim analysis
Enrolment: 328 participants (actual)
Lead sponsor: Bioventus LLCIndustry (pharma, biotech, devices)
Study start: Sep 2008
Primary completion: May 2012 (actual)
Study completion: May 2012 (actual)
First posted: 1 Sep 2008 (estimated)
Results: Posted 2 Apr 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Exogen 4000+	Active comparator	Device: Exogen 4000+Low intensity pulsed ultrasound (LIPUS) delivered via Exogen 4000+ (single transducer) device for a treatment duration of 20 minutes per fusion site per day.
Exogen 4000+ sham	Sham comparator	Device: Exogen 4000+ shamNon-active sham device identical to Exogen 4000+ (single transducer); treatment duration of 20 minutes per fusion site per day
Exospine	Active comparator	Device: ExospineLow intensity pulsed ultrasound delivered via Exospine device (dual transducers); treatment duration of 20 minutes per day
Exospine sham	Sham comparator	Device: Exospine shamNon-active sham device identical to Exospine (dual transducers); treatment duration of 20 minutes per day

Who may qualify

Ages: 18 to 81 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Exospine shamInactive Exospine LIPUS device (dual transducers)	Device	Exospine sham
ExospineActive Exospine LIPUS device (dual transducers)	Device	Exospine
Exogen 4000+Active Exogen LIPUS device (single transducer)	Device	Exogen 4000+
Exogen 4000+ shamInactive Exogen 4000+ LIPUS device (single transducer)	Device	Exogen 4000+ sham

Primary outcome

Number of Participants With Posterolateral Fusion Success at the Treated Level
Time frame: 12 months post treatment start
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.

Results and safety

Results posted to the registry on 2 Apr 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Exogen 4000+ Sham	8	7
Exogen 4000+	10	8
Exospine	0	0
Exospine Sham	0	0

Primary outcome: Number of Participants With Posterolateral Fusion Success at the Treated Level

Time frame: 12 months post treatment start. Number. Unit: participants

Measure	Exospine Sham n = 74	Exospine Active n = 85
Value	25	28

Exospine Sham vs Exospine Active: p = 0.9905, Cochran-Mantel-Haenszel

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

Adverse events

Time frame: 12 months post treatment start. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Exogen 4000+ Sham	1 of 8 (12.5%)	5 of 8 (62.5%)	Not reported
Exogen 4000+	0 of 10 (0%)	7 of 10 (70%)	Not reported
Exospine Sham	23 of 156 (14.7%)	56 of 156 (35.9%)	Not reported
Exospine	18 of 154 (11.7%)	59 of 154 (38.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Lumbar Degenerative Disc Disease

Active, not recruiting
Post Marketing Study of MagnetOs Easypack Putty Standalone Compared to Demineralized Bone Matrix or Fibers Mixed With Autograft in Patients Undergoing Posterolateral Lumbar Fusion
Degenerative Disc Disease, Spine Fusion
Not yet recruitingObservational study
Relationship Between Disability, Flexibility, Back Muscles, and Thoracolumbar Fascia in Patients With Lumbar Disc Degeneration
Intervertebral Disc Degeneration
Active, not recruiting
ASCEND: A Clinical Trial to Evaluate the Safety and Effectiveness of VIA Disc NP, a Supplement for Degenerated Intervertebral Discs
Degenerative Disc Disease, Disc Degeneration
Not yet recruiting
Kore Fiber PLF Study
Degenerative Lumbar Spine Diseases, Lumbar Degenerative Disc Disease
Recruiting
MagnetOs Flex Matrix Compared to Trinity Elite Mixed With Local Autograft in Patients Undergoing up to Four-level Instrumented Posterolateral Fusion
Degenerative Disc Disease, Spine Fusion

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jeffrey Fischgrund, MD principal investigator

Corewell Health East

Questions about this trial

What is this clinical trial studying?

A study testing Exospine and Exogen 4000+ in people with Lumbar Degenerative Disc Disease, run by Bioventus LLC.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 2 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Posterolateral Fusion Success at the Treated Level (time frame: 12 months post treatment start). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00744861.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2021.