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

NCT04566874 | Unknown DMC FDA Device

• 1 other identifier: SPA-2018
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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

Conditions

Degenerative Disc Disease; Spinal Stenosis; Spondylolisthesis; Scoliosis

Keywords

lumbar spinal fusion

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Oswestry Disability Index

  up to and including 24 months

• Back and Leg VAS

  up to and including 24 months

• VR-12 Health Survey

  up to and including 24 months

• PROMIS score

  up to and including 24 months

Study Arms (2)

Spira-A with HCT/p DBM

OTHER

Single level Spira-A 3D printed Titanium ALIF Device with HCT/p DBM

Device: ALIF

Medtronic PEEK ALIF with Infuse

ACTIVE COMPARATOR

Single level Medtronic Divergent-L/Perimeter PEEK ALIF Device with Recombinant Bone Morphogenic Protein-2 (Infuse)

Device: ALIF

Interventions

ALIF DEVICE

Anterior Lumbar Interbody Fusion

Medtronic PEEK ALIF with Infuse; Spira-A with HCT/p DBM

Eligibility Criteria

• Age: 22 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Camber Spine Technologies: lead

Study Sites (2)

Rothman Orthopaedic Institure

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

Texas Back Institute

Plano, Texas, 75093, United States

RECRUITING

MeSH Terms

Conditions

Intervertebral Disc Degeneration; Spinal Stenosis; Spondylolisthesis; Scoliosis

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Spondylolysis; Spondylosis; Spinal Curvatures

Study Officials

• David Kaye, MD

  Rothman Orthopaedic Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Donald W Guthner, BS

CONTACT

646.460.2984; dguthner@cambermedtech.com

Noel Hetrick

CONTACT

nhetrick@cambermedtech.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: single blind randomized 1:1

Study Record Dates

• First Submitted: September 17, 2020
• First Posted: September 28, 2020
• Study Start: July 13, 2020
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: September 28, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)