NCT01557829CompletedNot Applicable
Clinical Study of the Amedica Corporation Valeo OL Interbody Fusion Devices for Posterior Lumbar Interbody Fusion
Amedica Corporation3 sites in 1 country100 target enrollmentStarted: February 1, 2012Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 100
- Locations
- 3
- Primary Endpoint
- Roland Morris Disability Questionnaire (RMDQ)
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Roland Morris Disability Questionnaire (RMDQ)
Time Frame: 12 months post-op
The improvement in the RMDQ over the pre-op RMDQ value for each group will be compared
Secondary Outcomes
- Fusion status(3 mo., 6 mo., 12 mo., 24 months)
- Oswestry Disability Index (ODI)(12 months post-op)
Investigators
Study Sites (3)
Loading locations...
Similar Trials
Completed
Not Applicable
Comparison of DISCOVER™ Artificial Cervical Disc and ACDF for Treatment of Cervical DDD (IDE Study)Cervical Degenerative Disc DiseaseNCT00432159DePuy Spine500
Completed
Phase 4
A Trial Comparing Single Intra-op Dose of Methadone Versus Placebo in Patients Undergoing Spine SurgeryThoracolumbar ScoliosisNCT02206685Baylor College of Medicine74
Unknown
Not Applicable
Evaluation of Treatment Effect of Minimally Invasive Spinal Fusion SurgerySpinal FusionNCT05190055Chi Mei Medical Hospital73
Unknown
Phase 4
Conservative Versus Aggressive Discectomy for Primary Disc Herniation With RadiculopathyHerniated DiscNCT01204008Sun Yat-sen University100
Recruiting
Not Applicable
RCT Study of the Gelstix™ Device to Treat Chronic Discogenic Low Back Pain GelStix StudyDegeneration of Lumbar Intervertebral DiscNCT02763956Ospedale Regionale di Lugano72