Efficacy and Safety of Expandable Spacer in the Treatment of Degenerative Disc Disease Using the Minimally Invasive Transforaminal Lumbar Interbody Fusion Surgical Approach
| Status: | Completed |
|---|---|
| Conditions: | Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 2/17/2018 |
| Start Date: | July 2012 |
| End Date: | February 2017 |
Study of an Expandable Interbody Device for the Lumbar Spine
The primary objective of this study is to evaluate the safety and efficacy of CALIBER
expandable spacer for the treatment of degenerative disc disease. Radiographic outcomes,
intra-operative parameters, clinical outcomes, and patient satisfaction will be obtained from
patients in this 2 year follow-up clinical study.
expandable spacer for the treatment of degenerative disc disease. Radiographic outcomes,
intra-operative parameters, clinical outcomes, and patient satisfaction will be obtained from
patients in this 2 year follow-up clinical study.
Patients will be followed-up at 3weeks, 6 weeks, 3 months, 6 months, 12 and 24 months with
X-rays and questionnaires to determine their satisfaction, healing, fusion and return to work
status
X-rays and questionnaires to determine their satisfaction, healing, fusion and return to work
status
Inclusion Criteria:
- DDD at 1 or 2 levels between L2 and S1
- Between 18 and 80 years of age
- Unresponsiveness to documented non-surgical treatment modalities for a minimum of six
months
- Ability to provide a signed Informed Consent
Exclusion Criteria:
- Trauma at level(s) to be fused
- Previous documentation of osteopenia, osteoporosis, or osteomalacia to a degree that
spinal instrumentation would be contraindicated
- Immunosuppressive disorder
- History of substance abuse
- Any known allergy to a metal alloy
We found this trial at
2
sites
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Miami Beach, Florida 33140
Phone: 305-532-7494
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