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COMPLETED Phase 3

Greenwich Lumbar Stenosis SLIP Study

NCT00109213 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • PROCEDURE Lumbar Laminectomy with Instrumented Pedicle Screw Fusion
  • PROCEDURE Lumbar Laminectomy

Study Locations (5)

Massachusetts

  • Massachusetts General Hospital — Boston
  • Lahey Clinic — Burlington

Connecticut

  • Greenwich Hospital — Greenwich

Ohio

  • Cleveland Clinic Spine Institute — Cleveland

Rhode Island

  • Rhode Island Hospital — Providence

Trial Details

FieldValue
Enrollment Target 66 participants
Start Date 2002-05
Est. Completion 2014-10
Phase Phase 3

Sponsor

Greenwich Hospital

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00109213

The ClinicalTrials.gov registry entry for NCT00109213 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 66 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Greenwich Hospital, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Spondylolisthesis appearing as the primary indexed condition, and to 2 interventions — of which Lumbar Laminectomy with Instrumented Pedicle Screw Fusion is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00109213 reports 5 study locations spanning 4 distinct geographic areas — top geographies include Massachusetts, Connecticut, Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT00109213 about?

NCT00109213 is a clinical study titled "Greenwich Lumbar Stenosis SLIP Study". 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 ar...

What is the current status of trial NCT00109213?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 66 participants. The study started on 2002-05. Estimated completion is 2014-10.

What conditions does trial NCT00109213 study?

This clinical trial studies the following conditions: Spondylolisthesis, Spinal Stenosis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00109213?

The interventions under investigation include: Lumbar Laminectomy with Instrumented Pedicle Screw Fusion (PROCEDURE), Lumbar Laminectomy (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00109213?

This trial is sponsored by Greenwich Hospital, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00109213 being conducted?

This trial has 5 study locations across Connecticut, Massachusetts, Ohio, Rhode Island. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial