Decompression Versus Decompression and Fusion

Adjacent Segment Disease Clinical Trial

Official title:

Decompression Versus Decompression and Fusion for Lumbar Adjacent Segment Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04542720
• Other study ID #: 2020P000603
• Status: Recruiting
• Start date: September 1, 2020
• Est. completion date: September 2026

Study information

• Verified date: March 2024
• Source: Massachusetts General Hospital
• Contact: Daniel Tobert, MD
• Phone: 617-643-3932
• Email: DTOBERT[@]mgb.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: September 2026
• Est. primary completion date: September 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adjacent Segment Disease

Intervention

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
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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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