cervical degeneration degenerative disc disease of the cervical spine
Conditions
Interventions
Intercorporal cervical fusion via an anterior approach (ACDF). In one group a
bioresorbable (SOLIS RS) implant is used. The second group receives a
non-resorbable PEEK (SOLIS) implant. The patient i
Sponsors
Stryker SA SLCRG
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Willing and able to participate; Patient is male or female and between 18 and 70 years of age; Patient has clinical symptomatic myelopathy and/or radiculopathy; Based on clinical history, physical examination and radiographic evidence, pain interpreted as emanating between C3/4 and C6/7; No improvement of symptoms after at least 3 months of conservative treatment; Progressive neurological deficit despite conservative management irrespective of the duration; Evidence of degenerative changes between levels C3/4 and C6/7 (*spondylosis*) as shown on plain radiographs and/or CT scan and/or MRI. The pathology should be predominant on one level. Other levels may show degeneration, however, it should not be clinically necessary to operate on; Use of autograft from the iliac crest or the spine is necessary; Capable of providing informed consent.
Exclusion criteria
Exclusion criteria: Previous cervical spine surgery at the symptomatic level to be operated on and previous cervical spine surgery during the last two years at other levels; Symptomatic degenerative disc disorder at more than one cervical level; Pregnancy or planning a pregnancy during the two year study; Ongoing severe psychiatric illness or mental retardation; Evidence of alcohol and/or drug abuse; Inability to complete the questionnaires; Local or general infection which could jeopardize the surgical objective; Extensive local inflammatory reactions; Proven or suspected hypersensitivity to materials; Immunosuppressive pathologies; Abnormal, immature or weak bone structure, insufficient quantity or quality or diseased bone that is incapable of supporting or stabilizing the device; Severe pathologies of the airway, esophagus, abnormal vascostructure or bypassing nerves; Other indications than degenerative spinal disorders including a metabolic bone disease, osteoporosis, infection, previous cervical spinal fracture, inflammatory process or neoplasm (confirmed by radiographs and/or DEXA scans and/or CT and/or MRI); Excessive physical activity.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure is the rate of fusion in the two treatment groups. | — |
Secondary
| Measure | Time frame |
|---|---|
| Further objectives of the study are to assess clinical outcome parameters in both groups. Such parameters are primarily assessed using questionnaires (Neck Disability Index, Myelopathy Disability Index, Visual Analogue Scales for pain in the arm and neck and Prolo*s economic and functional scale.) The incidence and severity of adverse events are also compared between groups. | — |
Countries
Netherlands
Outcome results
None listed