Comparison of two different surgical approaches to decompress lumbar spinal nerves in patients with narrow lumbar spinal canal and instability

Recruiting

• Conditions: Spondylodesis; Musculoskeletal Diseases

• Registration Number: ISRCTN99263604
• Lead Sponsor: Medical University of Innsbruck

Brief Summary

2018 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/29463278

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-12-03
• Last Update Posted: 19 March 2018
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 154

Inclusion Criteria

1. Clinical signs of lumbar degenerative stenotic disease from L1 to S1
2. MRI and CT confirmed: central canal stenosis OR lateral recesses stenosis OR foraminal stenosis leading to:
2.1. Radiculopathy, defined as pain and/or motor weakness or paralysis and/or paraestethica in a at least one specific nerve root distribution from L1 to S1 or
2.2. Neurogenic intermittent claudication, defined as pain and/or weakness and/or abnormal sensation in the legs during walking or prolonged standing
3. Indicating decompressive surgery and instrumented mono-, bi- or trisegmental spondylodesis with posterior instrumented fusion system and an intervertebral cage (TLIF)
4. Unresponsive to non-operative treatment for a minimum of 3 months including at least physiotherapy, pain medication and local infiltration therapy
5. Presence of progressive symptoms or signs of nerve root and/or spinal cord compression although performing conservative treatment
6. Aged between 18 and 85 years

Exclusion Criteria

1. Previous surgery: Any instrumented lumbar spinal surgery, cervical and/or thoracic spinal disease to the extent that surgical consideration is likely or anticipated within 6 months after the lumbar surgical treatment
2. Other degenerative joint diseases (i.e. shoulder, hip knee) to the extent that surgical consideration is likely or anticipated within 6 months after or before the lumbar surgical treatment
3. Any other physical diseases (e.g. neuromuscular disorders) before and/or within 6 months after lumbar surgical intervention which are able to restrict study procedures (i.e. wheelchair bound) or preclude accurate clinical examination or outcome
4. Adipositas, severe obesity (BMI > 35 kg/m2)
5. Neoplasia as the source of symptoms
6. Fixed or permanent neurological deficit unrelated to the lumbar spine disease
7. Active or chronic infection, systemic or local, including HIV, AIDS, Hepatitis
8. 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
9. Autoimmune disorder that impacts the musculoskeletal system (i.e. lupus, rheumatoid arthritis, ankylosing spondylitis)
10. Acute episode or major mental illness (psychosis, major affective disorder or schizophrenia)
11. Physical symptoms without a diagnosable medical condition to account for the symptoms, which may indicate symptoms of psychological rather than physical origin
12. Recent or current history of substance abuse (drugs, alcohol, narcotics, recreational drugs)
13. Known allergy to titanium, Carbon/PEEK and tantalum or intolerance to any device material)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall success is measured using the oswestry disability index (ODI) at baseline, 3 days and 3, 6, 12, 24, 36, 48 and 60 months after surgery.