Status:
COMPLETED
Interbody Fusion Devices in the Treatment of Cervicobrachial Syndrome
Lead Sponsor:
Amedica Corporation
Conditions:
Radiating Pain
Myelopathy
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
This study randomizes neck and arm pain patients being treated with discectomy and anterior interbody fusion into two groups: one to receive a new ceramic implant and a control group with a more tradi...
Eligibility Criteria
Inclusion
- Age 18 75 years
- Radicular signs and symptoms in one or both arms (i.e., pain, paraesthesiae or paresis in a specific nerve root distribution) or symptoms and signs of acute or chronic myelopathy.
- At least 8 weeks prior conservative treatment (i.e., physical therapy, pain medication)
- Radiographic diagnosis of cervical disc herniation and/or osteophyte at 1 level (C3-C4 to C7-T1) in accordance with clinical signs and symptoms
- Ability and willingness to comply with project requirements
- Written informed consent given by the subject or the subject's legally authorised representative
Exclusion
- Previous cervical surgery (either anterior or posterior)
- Increased motion on dynamic studies (\> 3 mm)
- Severe segmental kyphosis of the involved disc level (\> 7 degrees)
- Patient cannot be imaged with MRI
- Neck pain only (without radicular or medullary symptoms)
- Infection
- Metabolic and bone diseases (osteoporosis, severe osteopenia)
- Neoplasma or trauma of the cervical spine
- Spinal anomaly (Klippel Feil, Bechterew, OPLL)
- Severe mental or psychiatric disorder
- Inadequate Dutch language
- Planned (e)migration abroad in the year after inclusion
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2015
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01511445
Start Date
December 1 2011
End Date
November 1 2015
Last Update
May 8 2017
Active Locations (1)
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1
Medical Center Haaglanden
The Hague, Netherlands, 2501 CK