The NORDSTEN Studies/ The Spinal Stenosis Study

Lumbar Spinal Stenosis Clinical Trial

— NORDSTEN/SST  

Official title:

Comparison of Different Surgical Treatments for Lumbar Spinal Stenosis. A Randomized Controlled Trial Comparing the Clinical and Radiological Results Using "Spinous Process Osteotomy", "Bilateral Laminotomy" and "Unilateral Laminotomy With Crossover"

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02007083
• Other study ID #: 2011/2034
• Secondary ID: 2011/2034
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 2013
• Est. completion date: December 2028

Study information

• Verified date: August 2020
• Source: Haukeland University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Lumbar Spinal Stenosis (LSS) is a clinical entity were narrowing of the spinal canal gives a compression of the the neural and vascular structures in the spinal canal. This often gives neurogenic claudication and sometimes severe Low Back Pain (LBP). Surgery for LSS is today the most often performed procedure in the adult lumbar spine. Beneficial effect of surgical treatment is well documented by several clinical trials, and a Cochrane review article from 2005 concludes that surgical treatment is superior to non-surgical treatment. The surgical solution is to decompress the stenotic part of the lumbar spine. There is no consensus in the literature of which surgical method that gives best long term clinical results. The investigators are therefore planning a Randomized Controlled Trial, where they will compare clinical and radiological results of three different surgical methods for LSS. The main outcome of this study is to answer which surgical method that gives the best long term clinical results. And, secondary outcome is to find out how much increase of the Dural Sac Cross Sectional Area is needed to give a long time relief of the patients` symptoms.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 465
• Est. completion date: December 2028
• Est. primary completion date: October 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• have clinical symptoms of spinal stenosis as neurogenic claudication or radiating pain into the bilaterally to the lower limbs, not responding to at least 3 months of conservative treatment.

• Radiological findings corresponding to the clinical symptoms of LSS. Central -stenosis, or lateral recess-stenosis.

• be able to give informed consent and to answer the questionnaires.

• over 18 years of age-have -not responding to at least 3 months of non-surgical treatment.

• be able to understand Norwegian language, spoken and in writing

Exclusion Criteria:

• have a degenerative lumbar spondylolisthesis, with a slip = 3 mm verified on standing plain x-rays in lateral view.

• are not willing to give written consent.

• have former surgery in the level of stenosis.

• fracture, or former fusion of the thoracolumbal region.

• cauda equina syndrome (bowel or bladder dysfunction) or fixed complete motor deficit.

• are ASA- classified 4 or 5.

• are older than 80 years

• have a lumbosacral scoliosis more than 20 degrees verified on AP-view

• have distinct symptoms in one or both of their legs due to other diseases, e.g. polyneuropaty, vascular claudication or osteoarthtris.

• LSS in 4 or more levels.

• not able to comply fully with the protocol, including treatment, follow-up or study procedures (psychosocially, mentally and physical).

• the patient is participating in another clinical trial that may interfere with this trial

Related Conditions & MeSH terms

• Constriction, Pathologic
• Lumbar Spinal Stenosis
• Spinal Stenosis

Intervention

Procedure:
• Bilateral laminotomy (BL)

• Unilateral laminotomy with crossover (UL)

• Spinous Process Osteotomy (SPO)

Locations

Country	Name	City	State
Norway	Haukeland University Hospital	Bergen	Hagevik

Sponsors (2)

Lead Sponsor	Collaborator
Haukeland University Hospital	Møre og Romsdal Hospital Trust

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Dural Sac Cross sectional Area (DSCSA)	The investigators are planning to investigate the DSCSA before and after surgery. Thereby we can monitor which surgical procedure that increases the DSCSA the most. The investigators will also investigate wether a large increase of the DSCSA is needed to maintain good long-time clinical results.	3 months after surgery
Primary	Oswestry Disability Index	The investigators will monitor the ODI-index before and after surgery, and calculate the change of ODI after surgery compared to baseline.; The primary outcome is a measurement of the change of ODI (version 2.0) from baseline in the three different surgical groups. This will be done by calculating the mean ODI improvement in each group. The investigators will also compare the proportion of "success patients" between the SPO group, the BL group and the UL group, 24 months after the operation. The investigators will dichotomize the patients, in a "succesful outcome group" and in a "non- succesful outcome group". The threshold value for being categorized as a "succesful outcome" will be computed in a planned study based on data from The Norwegian Registry for Spine Surgery (NORSpine).; The investigators also plan to asses short time results after 2 years, intermediate results after 5 years, and long time results after 10 years.	2, 5 and 10 years after surgery
Secondary	Zurich claudification Scale, Numeric Rating Scale for leg pain, Numeric Rating Scale for back pain, EQ-5D, and self evaluated effect of surgery.	All of the above mentioned questionaires are validated and reliable questionaires to asses the effect of surgical treatment. The effect of the surgical treatment is calculated by the improvement of the different scores, and thereby is an objective way to asses the effect of the surgical treatment.; The investigators plan to asses short time results after 2 years, intermediate results after 5 years, and long time results after 10 years.	2, 5 and 10 years after surgery