N/A
N=104
Interbody Fusion Devices in the Treatment of Cervicobrachial Syndrome
Radiating Pain · Myelopathy · Cervicobrachial Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT01511445 ↗Enrolled (actual)
104
Serious AEs
2.9%
Results posted
May 2017
Primary outcome: Primary: Neck Disability Index — 17.9; 16.7 units on a scale from 0 to 100 — p=0.641
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Anterior cervical discectomy and fusion (ACDF) with PEEK Cage (Device); Anterior cervical discectomy and fusion (ACDF) with a Valeo CSC Cage (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Amedica Corporation
- Primary completion
- Oct 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Neck Disability Index |
17.9; 16.7 | 0.641 |
| SECONDARY Fusion Status |
40; 37 | 0.710 |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01511445). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.