The NORDSTEN Studies/ The Spinal Stenosis Study (NORDSTEN/SST)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02007083|
Recruitment Status : Recruiting
First Posted : December 10, 2013
Last Update Posted : November 1, 2017
|Condition or disease||Intervention/treatment||Phase|
|Lumbar Spinal Stenosis||Procedure: Bilateral laminotomy (BL) Procedure: Unilateral laminotomy with crossover (UL) Procedure: Spinous Process Osteotomy (SPO)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||465 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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"|
|Study Start Date :||November 2013|
|Estimated Primary Completion Date :||October 2025|
|Estimated Study Completion Date :||December 2025|
Active Comparator: Bilateral laminotomy (BL)
The multifidus muscles is detached from the spinous process bilaterally.The decompression of the spinal canal is performed by first doing a flavectomy. Thereby performing a laminotomy (about 1/3) of the the lower part of the superior lamina, and a laminotomy of the upper part (about 1/4) of the inferior lamina. This is performed bilaterally.
Procedure: Bilateral laminotomy (BL)
Active Comparator: Unilateral laminotomy with crossover (UL)
The multifidus muscles is detached from the spinous process unilaterally. The laminotomy is first performed ipsilaterally. The decompression of the spinal canal is performed by first doing a flavectomy. Then, performing a laminotomy (about 1/3) of the the lower part of the superior lamina, and a laminotomy of the upper part (about 1/4) of the inferior lamina. Dura is then retracted, and the decompression is performed contralaterally.
Procedure: Unilateral laminotomy with crossover (UL)
Other Name: microdecompression.
Active Comparator: Spinous process osteotomy (SPO)
The multifidus muscles is detached from the spinous process unilaterally. An osteotomy of the superior spinous process is performed at the basis, in the actual level. The spinous process with intact interspinal and supraspinal ligaments is then retracted to the contralateral side. The decompression is first performed in the midline. Then one goes laterally on both sides too perform the decompression. About 1/3 of the lower part of the superior lamina is removed, and about 1/4 of the upper part of the inferior lamina is removed.
Procedure: Spinous Process Osteotomy (SPO)
- Oswestry Disability Index [ Time Frame: 2, 5 and 10 years after surgery ]
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.
- Zurich claudification Scale, Numeric Rating Scale for leg pain, Numeric Rating Scale for back pain, EQ-5D, and self evaluated effect of surgery. [ Time Frame: 2, 5 and 10 years after 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.
- Dural Sac Cross sectional Area (DSCSA) [ Time Frame: 3 months after surgery ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02007083
|Contact: Erland Hermansen, MD||+47 email@example.com|
|Contact: Kari Indrekvam, MD Dr.Med||+47 firstname.lastname@example.org|
|Haukeland University Hospital||Recruiting|
|Bergen, Hagevik, Norway, 5217|
|Contact: Erland Hermansen, MD +47 70105766 email@example.com|
|Contact: Kari Indrekvam, MD, Dr Med +47 56565800 firstname.lastname@example.org|
|Principal Investigator: Erland Hermansen, MD|
|Study Director:||Kari Indrekvam Indrekvam, MD, Dr Med||The Coastal Hospital of Hagevik, Orthopeadic Clinic, Haukeland University City|