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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00109213
Other study ID # GH-SLIP-384
Secondary ID
Status Completed
Phase Phase 3
First received April 26, 2005
Last updated December 2, 2015
Start date May 2002
Est. completion date October 2014

Study information

Verified date December 2015
Source Greenwich Hospital
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The purpose of the study is to determine the proper use of lower back screws and rods (instrumentation) and bony fusion in subjects with one level of degenerative spinal narrowing (stenosis) compressing nerves to the legs with one spinal bone slipping forward on another (spondylolisthesis). There are two types of operations that surgeons perform for this problem. Some spinal surgeons remove some bone in the back (laminectomy) to decompress the nerves. Other surgeons perform a laminectomy (decompression) as above, but feel that it is also important to strengthen the back by placing screws and rods into the spine and adding more bone to obtain a new bridge of bone away from the nerves (decompression with instrumented fusion). This study aims to test the hypothesis that adding instrumented fusion to a decompression for this spinal problem will improve long term patient outcomes.


Description:

There is considerable debate among spinal surgeons regarding the optimal surgical procedure for lumbar spinal stenosis with a grade I spondylolisthesis. The major question is whether or not instrumented pedicle screw fusion should be undertaken when a decompressive laminectomy is performed to relieve neural compression. This multi-center, randomized, prospective clinical study aims to address this question by testing the hypothesis that adding instrumented fusion to a decompression for this spinal problem will improve long-term patient outcomes.


Recruitment information / eligibility

Status Completed
Enrollment 66
Est. completion date October 2014
Est. primary completion date September 2009
Accepts healthy volunteers No
Gender Both
Age group 50 Years to 80 Years
Eligibility Inclusion Criteria:

- Symptomatic lumbar spinal stenosis and single level grade I spondylolisthesis (3-14 mm)

Exclusion Criteria:

- History of previous lumbar spinal surgery in region of stenosis

- Gross spinal instability (defined as greater than 3 mm motion on flexion/extension studies)

- Serious medical illness (ASA Class III or higher)

- Spondylolisthesis greater than 14 mm or associated with spondylolysis

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Procedure:
Lumbar Laminectomy with Instrumented Pedicle Screw Fusion
Removal of bone to decompress spinal nerves with placement of spinal screws and extra bone to strengthen the spine
Lumbar Laminectomy
Removal of bone to decompress spinal nerves

Locations

Country Name City State
United States Massachusetts General Hospital Boston Massachusetts
United States Lahey Clinic Burlington Massachusetts
United States Cleveland Clinic Spine Institute Cleveland Ohio
United States Greenwich Hospital Greenwich Connecticut
United States Rhode Island Hospital Providence Rhode Island

Sponsors (1)

Lead Sponsor Collaborator
Greenwich Hospital

Country where clinical trial is conducted

United States, 

References & Publications (3)

Fischgrund JS, Mackay M, Herkowitz HN, Brower R, Montgomery DM, Kurz LT. 1997 Volvo Award winner in clinical studies. Degenerative lumbar spondylolisthesis with spinal stenosis: a prospective, randomized study comparing decompressive laminectomy and arthrodesis with and without spinal instrumentation. Spine (Phila Pa 1976). 1997 Dec 15;22(24):2807-12. — View Citation

Ghogawala Z, Benzel EC, Amin-Hanjani S, Barker FG 2nd, Harrington JF, Magge SN, Strugar J, Coumans JV, Borges LF. Prospective outcomes evaluation after decompression with or without instrumented fusion for lumbar stenosis and degenerative Grade I spondylolisthesis. J Neurosurg Spine. 2004 Oct;1(3):267-72. — View Citation

Herkowitz HN, Kurz LT. Degenerative lumbar spondylolisthesis with spinal stenosis. A prospective study comparing decompression with decompression and intertransverse process arthrodesis. J Bone Joint Surg Am. 1991 Jul;73(6):802-8. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary SF-36 (physical component summary score) 2 year No
Secondary Oswestry Disability Index 2 year, 3 year, 4 year No
Secondary Major Complication rate 30 days No
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