CompletedNot Applicable

Valeo OL Interbody Fusion Devices for Posterior Lumbar Interbody Fusion SNAP Trial

Netherlands100 participantsStarted 2012-02

Plain-language summary

This study randomizes degenerative spondylolisthesis and/or degenerative disc patients into two groups: one to receive a new ceramic implant and a control group with a more traditional PEEK plastic implant. The procedure uses a single oblique cage in each group. The study will measure and compare pain and disability improvement with the two implanted devices over a period of two years. The fusion status will also be judged with plane x-rays and one CT scan.

Who can participate

Age range18 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Male and female patients age 18-75 years * Chronic low back pain unresponsive to at least six months of conservative care * MRI and standing x-ray evidence of Pfirrmann Grade III or greater disc degeneration and/or degenerative or isthmic spondylolisthesis of Grade I or II Exclusion Criteria: * Osteoporosis * Patients with prior failed fusion at the same level * Degenerative scoliosis * Degenerative spondylolisthesis greater than Grade II * Pregnancy * Psychiatric or mental disease * Alcoholism (drinking more than 5 units per day) * Active infection or prior infection at the surgical site * Active cancer * Insufficient language skills to complete questionnaires * Participation in another study * More than two symptomatic levels that need fusion

What they're measuring

Roland Morris Disability Questionnaire (RMDQ)

Timeframe: 12 months post-op

Trial details

NCT IDNCT01557829

SponsorAmedica Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-01

View on ClinicalTrials.gov More Disc Degeneration of Pfirrmann Grade III or Greater trials