Ultrasound as Adjunct Therapy for Increasing Fusion Success After Lumbar Surgery (EXO-SPINE)

Bioventus

Status: Terminated

Conditions: Lumbar Degenerative Disc Disease

Treatments: Device: Exospine sham; Device: Exogen 4000+; Device: Exospine; Device: Exogen 4000+ sham

Study type: Interventional

Funder types: Industry

Identifiers

NCT00744861

EX-SPINE0907

Details and patient eligibility

About

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

Full 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.

Enrollment: 328 patients

Sex: All

Ages: 18 to 81 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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328 participants in 4 patient groups

Exogen 4000+

Active Comparator group

Description:

Low intensity pulsed ultrasound (LIPUS) delivered via Exogen 4000+ (single transducer) device for a treatment duration of 20 minutes per fusion site per day.

Treatment:

Device: Exogen 4000+

Exogen 4000+ sham

Sham Comparator group

Description:

Non-active sham device identical to Exogen 4000+ (single transducer); treatment duration of 20 minutes per fusion site per day

Treatment:

Device: Exogen 4000+ sham

Exospine

Active Comparator group

Description:

Low intensity pulsed ultrasound delivered via Exospine device (dual transducers); treatment duration of 20 minutes per day

Treatment:

Device: Exospine

Exospine sham

Sham Comparator group

Description:

Non-active sham device identical to Exospine (dual transducers); treatment duration of 20 minutes per day

Treatment:

Device: Exospine sham