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

Status unconfirmed · Not applicable

Conditions studied: Degenerative Disc Disease, Spinal Stenosis, Spondylolisthesis, Scoliosis

In brief

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

Key facts

Study ID

NCT04566874

Run by

Camber Spine Technologies

People needed

100

Starts

2020-07-13

Expected to finish

2021-07-01

Last updated by the study team

2020-09-28

Who can join

Age: 22 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Rothman Orthopaedic Institure — Philadelphia, Pennsylvania, United States (enrolling)
• Texas Back Institute — Plano, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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