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

Degenerative Disc Disease Clinical Trial

Official title:

SPIRA™-A 3D Printed Titanium Anterior Lumbar Interbody Fusion Device and HCT/p Demineralized Bone Matrix Versus Medtronic Divergent™-L/Perimeter™ PEEK Anterior Lumbar Interbody Fusion Device and Recombinant Bone Morphogenic Protein-2

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04566874
• Other study ID #: SPA-2018
• Status: Recruiting
• Phase: N/A
• Start date: July 13, 2020
• Est. completion date: July 2021

Study information

• Verified date: September 2020
• Source: Camber Spine Technologies
• Contact: Donald W Guthner, BS
• Phone: 646.460.2984
• Email: dguthner[@]cambermedtech.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 2021
• Est. primary completion date: July 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Degenerative Disc Disease
• Intervertebral Disc Degeneration
• Scoliosis
• Spinal Stenosis
• Spondylolisthesis

Intervention

Device:
• ALIF
Anterior Lumbar Interbody Fusion

Locations

Country	Name	City	State
United States	Rothman Orthopaedic Institure	Philadelphia	Pennsylvania
United States	Texas Back Institute	Plano	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Camber Spine Technologies

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiographic Fusion	AP/Lateral, Flexion, Extension and CT radiographs	6 months
Primary	Radiographic Fusion	AP/Lateral, Flexion, Extension and CT radiographs	12 months
Primary	Radiographic Fusion	AP/Lateral, Flexion, Extension and CT radiographs	24 months
Secondary	Oswestry Disability Index	Improvement in the ODI as measured by a minimum of a 15 point improvement	up to and including 24 months
Secondary	Back and Leg VAS	Improvement in the VAS as measured by a minimum of a 20 point improvement.	up to and including 24 months
Secondary	VR-12 Health Survey	Improvement in the VR-12 Health Survey as demonstrated by pre-op and post-op evaluation	up to and including 24 months
Secondary	PROMIS score	Change in the PROMIS score	up to and including 24 months