Interbody Fusion Devices in the Treatment of Cervicobrachial Syndrome (NCT01511445) | Clinical Trial Compass
CompletedNot Applicable
Interbody Fusion Devices in the Treatment of Cervicobrachial Syndrome
Netherlands100 participantsStarted 2011-12
Plain-language 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 traditional plastic implant. The study will measure and compare pain and disability improvement with the two products 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:
* 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 Criteria:
* 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