"Is Instrumentation Necessary for "Static" Degenerative Spondylolisthesis"

NCT02530775 | Withdrawn

• 1 other identifier: PRO15040227
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Degenerative Spondylolisthesis; Spinal Stenosis

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (5)

• Rate of Infection

  Expected average of 4 weeks

• Rate of Symptomatic Pseudoarthrosis

  Up to 2 years

• Need for Revision Surgery

  Up to 2 years

• Length of Hospital Stay

  Expected average of 1 week

• Surgical Time

  2-4 hours

Study Arms (2)

instrumented arthrodesis

ACTIVE COMPARATOR

Degenerative Spondylolisthesis and Spinal Stenosis patients having a surgical procedure. The surgical procedure is the intervention and is a spinal fusion with use of instrumentation and lumbar laminectomy. No additional "drug" or "device" intervention.

Procedure: instrumented spinal fusion with laminectomy

non-instrumented arthrodesis

ACTIVE COMPARATOR

Degenerative Spondylolisthesis and Spinal Stenosis patients having a surgical procedure. The surgical procedure is the intervention and is a spinal fusion without the use of instrumentation and lumbar laminectomy. No additional "drug" or "device" intervention.

Procedure: non-instrumented spinal fusion with laminectomy

Interventions

instrumented spinal fusion with laminectomy PROCEDURE

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.

instrumented arthrodesis

non-instrumented spinal fusion with laminectomy PROCEDURE

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 arthrodesis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with stable L4-5 spondylolisthesis on lumbar flexion and extension radiographs. Stability will be determined by the treating physician.
• Patients with concomitant spinal stenosis.
• Laminectomy at any lumbar levels of stenosis.
• Fusion only at L4-5 level.

You may not qualify if:

• Prior lumbar spine surgery
• Multi-level spondylolisthesis
• Anterior interbody work/fusion
• Tumor
• Infection
• Trauma

Sponsors & Collaborators

• University of Pittsburgh: lead

MeSH Terms

Conditions

Spinal Stenosis

Interventions

Laminectomy

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Orthopedic Procedures; Therapeutics; Decompression, Surgical; Surgical Procedures, Operative; Neurosurgical Procedures

Study Officials

• Joon Y Lee, M.D.

  University of Pittsburgh Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: August 18, 2015
• First Posted: August 21, 2015
• Study Start: October 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 16, 2015

Record last verified: 2015-12