SPIRA™-A 3D and HCT/p DBM vs. Medtronic Divergent™-L/Perimeter™ and Recombinant BMP-2

Not Applicable

• Conditions: Degenerative Disc Disease; Spinal Stenosis; Spondylolisthesis; Scoliosis
• Interventions: Device: ALIF

• Registration Number: NCT04566874
• Lead Sponsor: Camber Spine Technologies

Brief Summary

A prospective, randomized, controlled clinical evaluation utilizing the SPIRA™ ALIF 3-D printed titanium interbody device with DBM vs a Medtronic PEEK ALIF interbody device with BMP

Detailed 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 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).

Study Timeline

• Study Start: 2020-07-13
• Status Verified: 2020-09
• Study First Submitted: 2020-09-17
• Study First Submitted QC: 2020-09-23
• Last Update Submitted: 2020-09-23
• Study First Posted: 2020-09-28
• Last Update Posted: 2020-09-28
• Primary Completion: 2021-07
• Study Completion: 2021-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• skeletally mature adults
• completed 6 month non-operative or conservative therapy
• signed informed consent
• back pain with radicular symptoms as evidenced by leg pain
• Degenerative Disc Disease involving a single level between L2 and S1
• subject willing to participate in study and follow protocol
• subject willing to comply with Post-op management program

Exclusion Criteria

• systemic infection such as AIDS, HIV or Active hepatitis
• autoimmune disease
• significant metabolic disease that might compromise bone growth
• history of malignancy
• previous surgery for primary tumor, trauma or infection
• subject requires 2 or more levels of fusion
• previous spinal instrumentation or previous interbody fusion at involved level
• spondylolisthesis of grade greater than/equal to 2

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Medtronic PEEK ALIF with Infuse	ALIF	Single level Medtronic Divergent-L/Perimeter PEEK ALIF Device with Recombinant Bone Morphogenic Protein-2 (Infuse)
Spira-A with HCT/p DBM	ALIF	Single level Spira-A 3D printed Titanium ALIF Device with HCT/p DBM

Primary Outcome Measures

Name	Time	Method
Radiographic Fusion	24 months	AP/Lateral, Flexion, Extension and CT radiographs

Secondary Outcome Measures

Name	Time	Method
Back and Leg VAS	up to and including 24 months	Improvement in the VAS as measured by a minimum of a 20 point improvement.
Oswestry Disability Index	up to and including 24 months	Improvement in the ODI as measured by a minimum of a 15 point improvement
VR-12 Health Survey	up to and including 24 months	Improvement in the VR-12 Health Survey as demonstrated by pre-op and post-op evaluation
PROMIS score	up to and including 24 months	Change in the PROMIS score

Trial Locations

Locations (2)

Rothman Orthopaedic Institure; 🇺🇸 Philadelphia, Pennsylvania, United States

Texas Back Institute; 🇺🇸 Plano, Texas, United States