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

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

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

Study Overview

• Status: Unknown
• Conditions: Scoliosis; Degenerative Disc Disease; Spinal Stenosis; Spondylolisthesis
• Intervention / Treatment: Device: ALIF

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Donald W Guthner, BS; Phone Number: 646.460.2984; Email: dguthner@cambermedtech.com
• Study Contact Backup: Name: Noel Hetrick; Email: nhetrick@cambermedtech.com

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Recruiting
      • Rothman Orthopaedic Institure
      • Contact: David Kaye, MD
  • Texas
    • Plano, Texas, United States, 75093
      • Recruiting
      • Texas Back Institute
      • Contact: Shannon Rusch, CCRC; Phone Number: 972-608-5143; Email: srusch@texasback.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Spira-A with HCT/p DBM; Single level Spira-A 3D printed Titanium ALIF Device with HCT/p DBM	Device: ALIF; Anterior Lumbar Interbody Fusion
ACTIVE_COMPARATOR: Medtronic PEEK ALIF with Infuse; Single level Medtronic Divergent-L/Perimeter PEEK ALIF Device with Recombinant Bone Morphogenic Protein-2 (Infuse)	Device: ALIF; Anterior Lumbar Interbody Fusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiographic Fusion	AP/Lateral, Flexion, Extension and CT radiographs	6 months
Radiographic Fusion	AP/Lateral, Flexion, Extension and CT radiographs	12 months
Radiographic Fusion	AP/Lateral, Flexion, Extension and CT radiographs	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oswestry Disability Index	Improvement in the ODI as measured by a minimum of a 15 point improvement	up to and including 24 months
Back and Leg VAS	Improvement in the VAS as measured by a minimum of a 20 point improvement.	up to and including 24 months
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
PROMIS score	Change in the PROMIS score	up to and including 24 months

Collaborators and Investigators

• Sponsor: Camber Spine Technologies
• Investigators: Principal Investigator: David Kaye, MD, Rothman Orthopaedic Institute

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 13, 2020
• Primary Completion (ANTICIPATED): July 1, 2021
• Study Completion (ANTICIPATED): July 1, 2021

Study Registration Dates

• First Submitted: September 17, 2020
• First Submitted That Met QC Criteria: September 23, 2020
• First Posted (ACTUAL): September 28, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 28, 2020
• Last Update Submitted That Met QC Criteria: September 23, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: lumbar spinal fusion
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Spondylolysis; Spondylosis; Scoliosis; Intervertebral Disc Degeneration; Spinal Stenosis; Spondylolisthesis
• Other Study ID Numbers: SPA-2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: data to be share with investigators only.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No