Status:
TERMINATED
Ultrasound as Adjunct Therapy for Increasing Fusion Success After Lumbar Surgery
Lead Sponsor:
Bioventus LLC
Conditions:
Lumbar Degenerative Disc Disease
Eligibility:
All Genders
18-81 years
Phase:
NA
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 posterolate...
Eligibility Criteria
Inclusion
- 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
- Requires spinal fusion at more than one lumbar level.
- Is pregnant, is lactating or plans to become pregnant before discontinuation of study treatment
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
328 Patients enrolled
Trial Details
Trial ID
NCT00744861
Start Date
September 1 2008
End Date
May 1 2012
Last Update
April 2 2021
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