Comparison of two surgical approaches to decompress bony spurs compressing the spinal nerve at the opening of the cervical spinal canal

Recruiting

Conditions: Spondylotic foraminal stenosis of the cervical spine
Musculoskeletal Diseases
Cervical spondylosis

Registration Number: ISRCTN82578069

Lead Sponsor: Innsbruck Medical University (Austria)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 88

Inclusion Criteria

1. Age between 18 - 80 years
2. Cervical spondylotic foraminal stenosis causing radiculopathy of C5 and/or C6 and/or C7 and requiring decompression of = 2 neuroforaminae
3. Radiculopathy is defined as pain, paralysis or paresthesia in corresponding nerve root distribution areas of C5 and/or C6 and/or C7, and must include at least arm/shoulder pain with minimum of 30 mm on 100 mm visual analogue scale (VAS)
4. Neck Disability Index (NDI) score = 30 out of 100
5. Unresponsive to non-operative treatment for six weeks or presence of progressive symptoms or signs of nerve root compression in the face of conservative treatment
6. Magnetic resonance imaging (MRI) and computerised tomography (CT) determined spondylotic foraminal stenosis at treatment level/levels that correlate to primary symptoms
7. Appropriate candidate for treatment using both an anterior approach via ventral discectomy and fusion or a posterior approach via foraminotomy as described by Frykholm
8. Psychosocially, mentally and physically able to fully comply with this protocol, including adhering to scheduled visits, treatment plan, completing forms and other study procedures
9. Personally signed and dated informed consent document prior to any study-related procedures indicating that the patient has been informed of all pertinent aspects of the trial.

Exclusion Criteria

Clinical criteria:
1. Previous cervical spinal surgery at index level
2. Lumbar or thoracic spinal disease to the extent that surgical consideration is likely or anticipated within 6 months after the cervical surgical treatment
3. Upper extremity degenerative joint diseases (i.e. shoulder) to the extent that:
3.1. Surgical consideration is likely or anticipated within 6 months after the cervical surgical treatment
3.2. The resulting pain is chronic (>3 months)
4. Axial neck pain in the absence of other symptoms of radiculopathy justifying the need for surgical intervention
5. Myelopathy
6. Neoplasia as the source of symptoms
7. Fixed or permanent neurological deficit unrelated to the cervical disc disease
8. Disease or conditions that preclude accurate clinical evaluation (e.g. neuromuscular disorders)
9. Active or chronic infection, systemic or local
10. Systemic disease including HIV, AIDS, hepatitis
11. Active malignancy defined as a history of any invasive malignancy, except non- melanoma skin cancer, unless the patient has been treated with curative intent and there have been no clinical signs or symptoms of the malignancy for a minimum of 5 years
12. Paget?s disease, osteomalacia, or any other metabolic bone disease (for osteoporosis see below)
13. Autoimmune disorder that impacts the musculoskeletal system (i.e. lupus, rheumatoid arthritis, ankylosing spondylitis)
14. Acute episode or major mental illness (psychosis, major affective disorder or schizophrenia)
15. Physical symptoms without a diagnosable medical condition to account for the symptoms, which may indicate symptoms of psychological rather than physical origin
16. Recent or current history of substance abuse (drugs, alcohol, narcotics, recreational drugs)
17. Anticipated long-term use of systemic steroid medications postoperatively

Radiological criteria:
1. A symptomatic spondylotic foraminal stenosis - considered for surgical intervention, with a contralateral asymptomatic spondylotic foraminal stenoses at the same level with equal or higher extent in the CT exams
2. Cervical disc herniation or central canal stenosis causing radiculopathy or clinical myelopathy
3. Myelopathy in the MRI exams
4. Marked cervical instability on flexion/extension radiographs defined as: Translation > 3mm and/or Angulation > 20°
5. Kyphotic segmental angulation >11° at treatment or adjacent levels

Varia (Other):
1. Patient is currently pursuing personal litigation related to spinal diseases
2. Prisoner or ward of the state
3. Patient has used another investigational drug or device within the last 30 days prior to surgery