NCT00744861

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
328

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2008

Longer than P75 for not_applicable

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 29, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 1, 2008

Completed
Same day until next milestone

Study Start

First participant enrolled

September 1, 2008

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
8.9 years until next milestone

Results Posted

Study results publicly available

April 2, 2021

Completed
Last Updated

April 2, 2021

Status Verified

March 1, 2021

Enrollment Period

3.7 years

First QC Date

August 29, 2008

Results QC Date

March 3, 2016

Last Update Submit

March 8, 2021

Conditions

Lumbar Degenerative Disc Disease

Keywords

Lumbar FusionexospineExo-SpineLIPUSExogen

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 months post treatment start

Study Arms (4)

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

Interventions

Exospine shamDEVICE

Inactive Exospine LIPUS device (dual transducers)

Exospine sham
ExospineDEVICE

Active Exospine LIPUS device (dual transducers)

Exospine
Exogen 4000+DEVICE

Active Exogen LIPUS device (single transducer)

Exogen 4000+
Exogen 4000+ shamDEVICE

Inactive Exogen 4000+ LIPUS device (single transducer)

Exogen 4000+ sham

Eligibility Criteria

Age18 Years - 81 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal Diseases

Results Point of Contact

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

Study Officials

  • Jeffrey Fischgrund, MD

    Corewell Health East

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2008

First Posted

September 1, 2008

Study Start

September 1, 2008

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

April 2, 2021

Results First Posted

April 2, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share