SPIRA™-A 3D and HCT/p DBM vs. Medtronic Divergent™-L/Perimeter™ and Recombinant BMP-2
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Degenerative Disc Disease
- Scoliosis
- Spinal Stenosis
- Spondylolisthesis
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: single blind randomized 1:1Masking: Single (Participant)Masking Description: subjects will be blinded prior to surgery. Following surgery, maintaining masking may not be feasible as subjects will have access to medical records and/or radiographs.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 22 years and 75 years
- Gender
- Both males and females
Description
This is a single blinded randomized 1:1, controlled, prospective clinical study to evaluate fusion status and patient reported outcomes in circumferential lumbar fusion between L2-S1 at a single level with posterior screw fixation (Camber Spine Orthros System) and anterior surgery consisting of one ...
This is a single blinded randomized 1:1, controlled, prospective clinical study to evaluate fusion status and patient reported outcomes in circumferential lumbar fusion between L2-S1 at a single level with posterior screw fixation (Camber Spine Orthros System) and anterior surgery consisting of one of the treatment groups: subjects treated with the SPIRA™-A Interbody Device and HCTP/p DBM or subjects treated with Medtronic Divergent-L or Perimeter™ PEEK ALIF Interbody Device and rhBMP-2 (6mg per level).
Tracking Information
- NCT #
- NCT04566874
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: David Kaye, MD Rothman Orthopaedic Institute
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