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Procedure

Decompression vs. Fusion Surgery for Spinal Wear

N/A

Recruiting

Led By Daniel Tobert, MD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with any prior posterior fusion involving L2 to the sacrum, whether single-level or multilevel

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months, 6 months, 1 year, and 2 years post-operation

Awards & highlights

Study Summary

This trial is comparing decompression (a surgery to relieve pressure on the spine) with decompression and fusion (a surgery to relieve pressure on the spine and joining two or more vertebrae together) for adjacent segment disease (a condition where the spine above or below a previous surgery starts to show signs of wear).

Who is the study for?

This trial is for adults who've had lumbar fusion surgery involving L2 to the sacrum and are experiencing symptoms at the level above their fusion despite six weeks of non-surgical treatment. They should be at least one year post-op from a previous instrumented posterior lumbar fusion. Those with uninstrumented fusions, trauma, tumors, infections at the adjacent segment, prior pelvic fixations or instability won't qualify.Check my eligibility

What is being tested?

The study aims to compare two surgical approaches for Adjacent Segment Disease in the spine: decompression alone versus decompression combined with an extension of existing spinal instrumentation and fusion. Participants will be randomly assigned to either group to see which method is more effective.See study design

What are the potential side effects?

Potential side effects may include typical surgical risks such as infection, bleeding, nerve damage or worsening of symptoms. Fusion surgery might also lead to stiffness and longer recovery times compared to decompression alone.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have had spine surgery involving L2 to the sacrum.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months, 6 months, 1 year, and 2 years post-operation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months, 6 months, 1 year, and 2 years post-operation

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months, 6 months, 1 year, and 2 years post-operation for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Global Health, Physical

Physical Function, short form 10a (SF10a)

Secondary outcome measures

Anxiety, short form 4a (SF4a)

Depression, short form 4a (SF4a)

Global Health, Mental

+5 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Observational: Extension FusionExperimental Treatment1 Intervention

Eligible patients may have a preference for the surgical procedure they wish to have. In these instances, they may choose to undergo a decompression alone or a decompression with extension of fusion. These patients are eligible for the study and will be enrolled under observational arms. This arm refers to the decompression with extension of fusion observational study arm.

Group II: Observational: DecompressionExperimental Treatment1 Intervention

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor

2,932 Previous Clinical Trials

13,198,394 Total Patients Enrolled

Daniel Tobert, MDPrincipal InvestigatorMassachusetts General Hospital

Media Library

Decompression (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04542720 — N/A

Adjacent Segment Disease Research Study Groups: Observational: Extension Fusion, Observational: Decompression

Adjacent Segment Disease Clinical Trial 2023: Decompression Highlights & Side Effects. Trial Name: NCT04542720 — N/A

Decompression (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04542720 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any remaining opportunities for individuals to join this clinical trial?

"The details hosted on clinicaltrials.gov demonstrate that, as of April 4th 2022, this trial is actively recruiting volunteers. This medical research was first published September 1st 2020."

Answered by AI

What results are researchers expecting to attain from this trial?

"The primary outcome of this investigation, which will be assessed over a 3-month, 6-month, 1 year and 2 years period post-procedure is Global Health Physical. Secondary outcomes include Hospital Length of Stay (quantified by the duration of hospitalisation after treatment), Pain Interference (using Patient Reported Outcome Measurement Information System [PROMIS] scores ranging from 41 to 76; higher score signifies improved results) and Depression (measured using PROMIS with scores between 41 - 80)."

Answered by AI

How many individuals have been selected to participate in this medical experiment?

"Affirmative. The information on clinicaltrials.gov indicates that this medical trial is actively looking for participants, having been initially posted on September 1st 2020 and most recently updated on April 4th 2022. In order to fulfil the study's requirements, 96 volunteers must be recruited from a single site."

Answered by AI

Recent research and studies

SpineJournal

Single- Versus Multilevel Fusion for Single-level Degenerative Spondylolisthesis and Multilevel Lumbar Stenosis

Smorgick, Yossi, Daniel K. Park, Kevin C. Baker, Jon D. Lurie, Tor D. Tosteson, Wenyan Zhao, Harry N. Herkowitz, Jeffrey S. Fischgrund, and James N. Weinstein. 2013. “Single- Versus Multilevel Fusion for Single-level Degenerative Spondylolisthesis and Multilevel Lumbar Stenosis”. Spine. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/brs.0b013e31827db30f.

World NeurosurgeryJournal

Factors Predictive of Adjacent Segment Disease After Lumbar Spinal Fusion

Maragkos, Georgios A., Rouzbeh Motiei-Langroudi, Aristotelis S. Filippidis, Paul A. Glazer, and Efstathios Papavassiliou. 2020. “Factors Predictive of Adjacent Segment Disease After Lumbar Spinal Fusion”. World Neurosurgery. Elsevier BV. doi:10.1016/j.wneu.2019.09.112.

SpineJournal

Lumbosacral Spinal Fusion A Biomechanical Study

LEE, CASEY K., and NOSHIR A. LANGRANA. 1984. “Lumbosacral Spinal Fusion A Biomechanical Study”. Spine. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/00007632-198409000-00007.

The Spine JournalJournal