"Is Instrumentation Necessary for "Static" Degenerative Spondylolisthesis"

Spinal Stenosis Clinical Trial

Official title:

"Is Instrumentation Necessary for "Static" Degenerative Spondylolisthesis - A Prospective Randomized Clinical Study"

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02530775
• Other study ID #: PRO15040227
• Status: Withdrawn
• Phase: N/A
• First received: August 18, 2015
• Last updated: December 15, 2015
• Start date: October 2015
• Est. completion date: December 2015

Study information

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

Clinical Trial Summary

The purpose of this study is to determine whether instrumented lumbar fusion provides superior clinical outcomes in comparison to non-instrumented fusion in patients with "static" degenerative spondylolisthesis.

Description:

This study will determine whether instrumented lumbar fusion will provide superior clinical outcomes in comparison to non-instrumented fusion in patients with "STATIC" degenerative spondylolisthesis. At the time of scheduling surgery, patients who meet the inclusion/exclusion criteria will be asked to participate. Patients who agree, will be randomized to either non-instrumented or instrumented arthrodesis group. Intra-operative, peri-operative, and post-operative data will be collected and compared. The investigators predict to get very similar clinical outcomes between the two groups, with possibly less complications from the non-instrumented group and definitely a reduction in cost compared to the instrumented group.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients with stable L4-5 spondylolisthesis on lumbar flexion and extension radiographs. Stability will be determined by the treating physician.

2. Patients with concomitant spinal stenosis.

3. Laminectomy at any lumbar levels of stenosis.

4. Fusion only at L4-5 level.

Exclusion Criteria:

1. Prior lumbar spine surgery

2. Multi-level spondylolisthesis

3. Anterior interbody work/fusion

4. Tumor

5. Infection

6. Trauma

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Degenerative Spondylolisthesis
• Spinal Stenosis
• Spondylolisthesis

Intervention

Procedure:
• instrumented spinal fusion with laminectomy
Once determined that a patient has single level "static" degenerative spondylolisthesis and is planning to schedule surgery the patient will be approached by a research team member explaining the study and reviewing the informed consent document. If the patient chooses to participate, he or she will be randomized to be apart of the non-instrumented arthrodesis with laminectomy group or the instrumented arthrodesis with laminectomy group. Both are standard approved surgical approaches; however, using instrumentation is the more commonly used approach.
• non-instrumented spinal fusion with laminectomy
Once determined that a patient has single level "static" degenerative spondylolisthesis and is planning to schedule surgery the patient will be approached by a research team member explaining the study and reviewing the informed consent document. If the patient chooses to participate, he or she will be randomized to be apart of the non-instrumented arthrodesis with laminectomy group or the instrumented arthrodesis with laminectomy group. Both are standard approved surgical approaches; however, using instrumentation is the more commonly used approach.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional Outcome Scores: SF-12/SF-36 Quality of Life Questionnaires	Measured by patient outcome survey such as the SF-12 or SF-36 Questionnaire (all questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning possible)	Up to 2 years	No
Primary	Functional Outcome Scores: Oswestry Disability Index (ODI) Questionnaire	Measured by patient outcome survey such as the Oswestry Disability Index (ODI) that assesses low back pain (scoring ranges from 0 to >35)	Up to 2 years	No
Secondary	Rate of Infection	Wound Complications	Expected average of 4 weeks	No
Secondary	Rate of Symptomatic Pseudoarthrosis		Up to 2 years	No
Secondary	Need for Revision Surgery	Return to the OR	Up to 2 years	No
Secondary	Length of Hospital Stay		Expected average of 1 week	No
Secondary	Surgical Time		2-4 hours	No