Recruiting

SPIRA™-A 3D & Medtronic Divergent™-L

Sponsor:

Camber Spine Technologies

Code:

NCT04566874

Conditions

Degenerative Disc Disease

Spinal Stenosis

Spondylolisthesis

Scoliosis

Eligibility Criteria

Sex: All

Age: 22 - 70+

Healthy Volunteers: Not accepted

Interventions

ALIF

Study Details

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

Study ID

NCT04566874

Start date

Jul 13, 2020

Status verified date

Sep, 2020

Completion date

Jul, 2021

Anticipated

Primary completion date

Jul, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Spira-A with HCT/p DBM

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

active comparator: Medtronic PEEK ALIF with Infuse

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

Interventions

ALIF

Anterior Lumbar Interbody Fusion

Primary outcome measure

  • Radiographic Fusion [ Time Frame: 6 months ]
  • Radiographic Fusion [ Time Frame: 12 months ]
  • Radiographic Fusion [ Time Frame: 24 months ]

Central Contacts and Locations

Central contacts

Donald W Guthner, BS

646.460.2984dguthner@cambermedtech.com

Noel Hetrick

nhetrick@cambermedtech.com

Locations

Rothman Orthopaedic Institure

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Texas Back Institute

Recruiting

Plano, Texas, United States, 75093

Contacts

Shannon Rusch, CCRC

972-608-5143srusch@texasback.com

More Information

Sponsor

Camber Spine Technologies

Last update posted

Sep 28, 2020

Last verified

Sep, 2020

Keywords

  • lumbar spinal fusion

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Camber Spine Technologies on 2020-09-28.