Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000056099
Ethics application status
Approved
Date submitted
15/01/2010
Date registered
19/01/2010
Date last updated
19/01/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Minimally invasive surgical treatment of degenerative lumbar spinal stenosis
Scientific title
Unilateral laminotomy for decompression of lumbar stenosis is effective and safe
Secondary ID [1] 1291 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Surgical treatment of degeneration in lumbar spine causing stenosis 256545 0
Condition category
Condition code
Musculoskeletal 256717 256717 0 0
Other muscular and skeletal disorders
Surgery 256730 256730 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Unilateral laminotomy for decompression of lumbar spinal stenosis. This minimally invasive surgical technique has many advantage; small incision,minimal tissue dissection,preserving the integrity of both facet and ligament-muscle complex and do not cause spinal instability. Operation time is similar to standard technique laminectomy. Approximate duration is one hour for one level.
Intervention code [1] 255820 0
Treatment: Surgery
Comparator / control treatment
Laminectomy for decompression of lumbar spinal stenosis. This is standard technique for treatment of LSS. In this technique wide exposure and decompresion may cause spinal instability and lower clinical success rate.
Control group
Active

Outcomes
Primary outcome [1] 257645 0
Relief back and leg pain. Pain and disability is assessed by Oswsetry Pain Disability Index (ODI). This questionnaire will be applied preoperatively and postoperatively.
Timepoint [1] 257645 0
Pain and disability will be assessed by ODI in postoperative 1. and 6 months.
Secondary outcome [1] 262915 0
Increase in maximum walking distance
Timepoint [1] 262915 0
Maximum walking distance will be assessed in preoperative period and this assessment will be repeated in postoperative 1. month and 6. month.

Eligibility
Key inclusion criteria
1) Symptoms of neurogenic claudication or radiculopathy; 2) radiological evidence of degenerative lumbar stenosis; 3) absence of associated pathological entities such as instability and significant disc herniation; and 4) absence of previous surgery for lumbar spine disorder.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
history of surgery for lumbar spine

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
52
Accrual to date
Final
Recruitment outside Australia
Country [1] 2407 0
Turkey
State/province [1] 2407 0

Funding & Sponsors
Funding source category [1] 256313 0
University
Name [1] 256313 0
Cumhuriyet University
Country [1] 256313 0
Turkey
Primary sponsor type
University
Name
Cumhuriyet University
Address
Cumhuriyet Universitesi Hastanesi 58140 Sivas
Country
Turkey
Secondary sponsor category [1] 251638 0
None
Name [1] 251638 0
Address [1] 251638 0
Country [1] 251638 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258400 0
the institutional ethics committee of Cumhuriyet University Faculty of Medicine
Ethics committee address [1] 258400 0
Ethics committee country [1] 258400 0
Turkey
Date submitted for ethics approval [1] 258400 0
Approval date [1] 258400 0
Ethics approval number [1] 258400 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30705 0
Address 30705 0
Country 30705 0
Phone 30705 0
Fax 30705 0
Email 30705 0
Contact person for public queries
Name 13952 0
Mustafa Gurelik
Address 13952 0
Cumhuriyet Universitesi Hastanesi Beyin Cerrahi Poliklinigi 58140 Sivas
Country 13952 0
Turkey
Phone 13952 0
+90 346 2580781
Fax 13952 0
Email 13952 0
[email protected]
Contact person for scientific queries
Name 4880 0
Mustafa Gurelik
Address 4880 0
Cumhuriyet Universitesi Hastanesi Beyin Cerrahi Poliklinigi 58140 Sivas
Country 4880 0
Turkey
Phone 4880 0
+90 346 2580781
Fax 4880 0
Email 4880 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.