Adjacent Segment DiseaseNCT04542720
Decompression Versus Decompression and Fusion
An observational study of Adjacent Segment Disease, run by Massachusetts General Hospital at 1 site in United States.
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%. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Adjacent Segment Disease
- What is being tested?
- Observational: Decompression and Observational: Extension Fusion
- Type of treatment
- Surgery or procedure
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2020to Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Daniel Tobert, MD
Daniel Tobert, MD
About this study
Official title: 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.
- Conditions
- Adjacent Segment Disease
- Being tested
- Observational: Decompression, Observational: Extension Fusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational: DecompressionProcedure or surgery
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 FusionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Observational: Decompression | |
| 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. Receives: Procedure: Observational: Extension Fusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global Health, Physical
Scored by Patient-Reported Outcomes Measurement Information System (PROMIS): 16-68 (higher score = better outcome)
Measured: 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)
Measured: 3 months, 6 months, 1 year, and 2 years post-operation
Secondary outcomes (8)
Global Health, Mental
Scored by Patient-Reported Outcomes Measurement Information System (PROMIS): 21-68 (higher score = better outcome)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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/
Measured: 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.
Measured: 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
Measured: 3 months, 6 months, 1 year, and 2 years post-operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2020
- Study start1 Sep 2020
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Adjacent Segment DiseaseStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel G.Tobert, M.D., Massachusetts General Hospital
- Investigators
- Daniel Tobert, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04542720
- Sponsor's protocol ID
- 2020P000603
- Status last verified
- Nov 2025
- First submitted
- 27 Aug 2020
- Last updated
- 21 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 21168094Ghiselli 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.
PubMed 15252099Lee 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.
PubMed 6495027Radcliff 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.
PubMed 23773433Maragkos 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.
PubMed 31568911Smorgick 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.
PubMed 23169068Dawson 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.
PubMed 19787044
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decompression Versus Decompression and Fusion for Lumbar Adjacent Segment Disease
- ClinicalTrials.gov ID
- NCT04542720
- Acronym / sponsor ID
- 2020P000603
- Conditions
- Adjacent Segment Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 9 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Observational: Decompression | – | Procedure: Observational: DecompressionEligible 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. |
| Observational: Extension Fusion | – | Procedure: Observational: Extension FusionEligible 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational: DecompressionPatients 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. | Procedure or surgery | Observational: Decompression |
| Observational: Extension FusionPatients 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. | Procedure or surgery | Observational: Extension Fusion |
Primary outcome
Global Health, Physical
Time frame: 3 months, 6 months, 1 year, and 2 years post-operation
Scored by Patient-Reported Outcomes Measurement Information System (PROMIS): 16-68 (higher score = better outcome)
Physical Function, short form 10a (SF10a)
Time frame: 3 months, 6 months, 1 year, and 2 years post-operation
Scored by Patient-Reported Outcomes Measurement Information System (PROMIS): 0-62 (higher score = better outcome)
8 secondary outcomes
Global Health, Mental
Time frame: 3 months, 6 months, 1 year, and 2 years post-operation
Pain intensity, short form 3a (SF3a)
Time frame: 3 months, 6 months, 1 year, and 2 years post-operation
Anxiety, short form 4a (SF4a)
Time frame: 3 months, 6 months, 1 year, and 2 years post-operation
Depression, short form 4a (SF4a)
Time frame: 3 months, 6 months, 1 year, and 2 years post-operation
Pain interference, short form 4a (SF4a)
Time frame: 3 months, 6 months, 1 year, and 2 years post-operation
Post-operative complication
Time frame: 3 months, 6 months, 1 year, and 2 years post-operation
Hospital length of stay
Time frame: 3 months, 6 months, 1 year, and 2 years post-operation
Post-operative narcotic utilization
Time frame: 3 months, 6 months, 1 year, and 2 years post-operation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Background: PubMed 21168094Sears 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.
- Background: PubMed 15252099Ghiselli 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.
- Background: PubMed 6495027Lee 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.
- Background: PubMed 23773433Radcliff 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.
- Background: PubMed 31568911Maragkos 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.
- Background: PubMed 23169068Smorgick 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.
- Background: PubMed 19787044Dawson 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Daniel Tobert, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adjacent Segment Disease, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel Tobert, MD (617-643-3932, DTOBERT@mgb.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global Health, Physical (time frame: 3 months, 6 months, 1 year, and 2 years post-operation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04542720, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.