Decompression Versus Decompression and Fusion

Decompression Versus Decompression and Fusion for Lumbar Adjacent Segment Disease

Adjacent segment disease (ASD) in the lumbar spine is a well-known sequela of lumbar fusion surgery. The annual incidence of adjacent level re-operation is approximately 3% with a ten-year prevalence of 20-30%. Frequently, the surgical treatment involves decompression of the adjacent level coupled with extension of the instrumentation and fusion. Advocates of this paradigm cite the altered kinematics and biomechanics of levels adjacent to a lumbar fusion mass. Furthermore, decompressed levels adjacent to a fused segments are associated with higher rates of ASD in retrospective studies. Yet, a retrospective review of higher quality data concluded decompression adjacent to single-level fusion provides similar outcomes compared to fusions extending across the decompressed segments.

Given the conflicting data currently available, higher quality data are needed to guide surgical decision-making in ASD. The purpose of this trial is to prospectively compare decompression and decompression with fusion in patients with lumbar ASD.

Study Overview

• Status: Recruiting
• Conditions: Adjacent Segment Disease
• Intervention / Treatment: Procedure: Observational: Decompression; Procedure: Observational: Extension Fusion

• Study Type: Observational
• Enrollment (Estimated): 96
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Daniel Tobert, MD; Phone Number: 617-643-3932; Email: DTOBERT@mgb.org
• Study Contact Backup: Name: Theresa L Chua, BS/BA; Phone Number: 617-643-3932; Email: tchua1@mgh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital
      • Contact: Daniel Tobert, MD
      • Principal Investigator: Daniel Tobert, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Adult patients at least one year removed from a previous instrumented posterior lumbar fusion will be considered for inclusion in this trial. Any prior posterior fusion involving L2 to the sacrum will be included, whether single-level or multilevel. Patients with symptoms related to central and lateral recess at the suprajacent level that have persisted despite at least six weeks of non-operative therapy modalities will be eligible.

Description

Inclusion Criteria:

• Adult patients at least one year removed from a previous instrumented posterior lumbar fusion
• Patients with any prior posterior fusion involving L2 to the sacrum, whether single-level or multilevel
• Patients with symptoms related to central and lateral recess at the supradjacent level that have persisted despite at least six weeks of non-operative therapy modalities

Exclusion Criteria:

• Patients with previous uninstrumented lumbar fusions
• Patients with traumatic, neoplastic, or infectious etiologies at the adjacent segment
• Patients with prior iliac or sacroiliac fixation and those with nonunion as the primary indication for surgery
• Patients with pre-existing instability at the supradjacent level. The definition of instability will be determined based on standing lateral, flexion and extension plain radiographs. Patients with >3mm of change between these views will be excluded.
• Retrolisthesis will not be a criterion for exclusion

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Observational: Decompression; 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 alone observational study arm.	Procedure: Observational: Decompression; Patients will undergo decompression alone of the supradjacent level. The surgical technique will be surgeon dependent. All surgeons will be encouraged to avoid damaging facet joints above the fusion mass, retaining 50% of the pars of the decompressed level and performing as minimal of a medial facetectomy as necessary.
Observational: Extension Fusion; 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.	Procedure: Observational: Extension Fusion; Patients will undergo decompression and extension of posterior instrumentation and fusion. This may or may not include exchange of pre-existing instrumentation. The use of interbody cages will be left to the discretion of the treating surgeon. The purpose of introducing this heterogeneity is to increase the generalizability of the trial results. The fusion cohort will not utilize bone morphogenetic protein products.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Global Health, Physical	Scored by Patient-Reported Outcomes Measurement Information System (PROMIS): 16-68 (higher score = better outcome)	3 months, 6 months, 1 year, and 2 years post-operation
Physical Function, short form 10a (SF10a)	Scored by Patient-Reported Outcomes Measurement Information System (PROMIS): 0-62 (higher score = better outcome)	3 months, 6 months, 1 year, and 2 years post-operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Global Health, Mental	Scored by Patient-Reported Outcomes Measurement Information System (PROMIS): 21-68 (higher score = better outcome)	3 months, 6 months, 1 year, and 2 years post-operation
Pain intensity, short form 3a (SF3a)	Scored by Patient-Reported Outcomes Measurement Information System (PROMIS): 30-72 (higher score = better outcome)	3 months, 6 months, 1 year, and 2 years post-operation
Anxiety, short form 4a (SF4a)	Scored by Patient-Reported Outcomes Measurement Information System (PROMIS): 40-82 (higher score = better outcome)	3 months, 6 months, 1 year, and 2 years post-operation
Depression, short form 4a (SF4a)	Scored by Patient-Reported Outcomes Measurement Information System (PROMIS): 41-80 (higher score = better outcome)	3 months, 6 months, 1 year, and 2 years post-operation
Pain interference, short form 4a (SF4a)	Scored by Patient-Reported Outcomes Measurement Information System (PROMIS): 41-76 (higher score = better outcome)	3 months, 6 months, 1 year, and 2 years post-operation
Post-operative complication	Scored by Clavien-Dindo classification (Grade I, II, IIIa, IIIb, IVa, IVb, and V) defined at https://www.assessurgery.com/clavien-dindo-classification/	3 months, 6 months, 1 year, and 2 years post-operation
Hospital length of stay	Scored by how long the patient is in the hospital after operation.	3 months, 6 months, 1 year, and 2 years post-operation
Post-operative narcotic utilization	Scored by morphine milligram equivalents (MME) utilized more than 90 days after surgery	3 months, 6 months, 1 year, and 2 years post-operation

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: Daniel Tobert, MD, Massachusetts General Hospital

Publications and helpful links

General Publications

• Sears WR, Sergides IG, Kazemi N, Smith M, White GJ, Osburg B. Incidence and prevalence of surgery at segments adjacent to a previous posterior lumbar arthrodesis. Spine J. 2011 Jan;11(1):11-20. doi: 10.1016/j.spinee.2010.09.026.
• Ghiselli G, Wang JC, Bhatia NN, Hsu WK, Dawson EG. Adjacent segment degeneration in the lumbar spine. J Bone Joint Surg Am. 2004 Jul;86(7):1497-503. doi: 10.2106/00004623-200407000-00020.
• Lee CK, Langrana NA. Lumbosacral spinal fusion. A biomechanical study. Spine (Phila Pa 1976). 1984 Sep;9(6):574-81. doi: 10.1097/00007632-198409000-00007.
• Radcliff KE, Kepler CK, Jakoi A, Sidhu GS, Rihn J, Vaccaro AR, Albert TJ, Hilibrand AS. Adjacent segment disease in the lumbar spine following different treatment interventions. Spine J. 2013 Oct;13(10):1339-49. doi: 10.1016/j.spinee.2013.03.020. Epub 2013 Jun 15.
• Maragkos GA, Motiei-Langroudi R, Filippidis AS, Glazer PA, Papavassiliou E. Factors Predictive of Adjacent Segment Disease After Lumbar Spinal Fusion. World Neurosurg. 2020 Jan;133:e690-e694. doi: 10.1016/j.wneu.2019.09.112. Epub 2019 Sep 27.
• Smorgick Y, Park DK, Baker KC, Lurie JD, Tosteson TD, Zhao W, Herkowitz HN, Fischgrund JS, Weinstein JN. Single- versus multilevel fusion for single-level degenerative spondylolisthesis and multilevel lumbar stenosis: four-year results of the spine patient outcomes research trial. Spine (Phila Pa 1976). 2013 May 1;38(10):797-805. doi: 10.1097/BRS.0b013e31827db30f.
• Dawson L, Zarin DA, Emanuel EJ, Friedman LM, Chaudhari B, Goodman SN. Considering usual medical care in clinical trial design. PLoS Med. 2009 Sep;6(9):e1000111. doi: 10.1371/journal.pmed.1000111. Epub 2009 Sep 29.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: August 27, 2020
• First Submitted That Met QC Criteria: September 2, 2020
• First Posted (Actual): September 9, 2020

Study Record Updates

• Last Update Posted (Actual): March 22, 2024
• Last Update Submitted That Met QC Criteria: March 19, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2020P000603

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No