Notice2025-00548
Supplemental Evidence and Data Request on The Performance of Fusion Procedures for Degenerative Disease of the Lumbar Spine
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Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
January 14, 2025
Issuing agencies
Health and Human Services DepartmentAgency for Healthcare Research and Quality
Abstract
The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review on The Performance of Fusion Procedures for Degenerative Disease of the Lumbar Spine, which is currently being conducted by the AHRQ's Evidence-based Practice Centers (EPC) Program. Access to published and unpublished pertinent scientific information will improve the quality of this review.
Full Text
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<title>Federal Register, Volume 90 Issue 8 (Tuesday, January 14, 2025)</title>
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[Federal Register Volume 90, Number 8 (Tuesday, January 14, 2025)]
[Notices]
[Pages 3214-3218]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-00548]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Supplemental Evidence and Data Request on The Performance of
Fusion Procedures for Degenerative Disease of the Lumbar Spine
AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS.
ACTION: Request for Supplemental Evidence and Data Submission.
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SUMMARY: The Agency for Healthcare Research and Quality (AHRQ) is
seeking scientific information submissions from the public. Scientific
information is being solicited to inform our review on The Performance
of Fusion Procedures for Degenerative Disease of the Lumbar Spine,
which is currently being conducted by the AHRQ's Evidence-based
Practice Centers (EPC) Program. Access to published and unpublished
pertinent scientific information will improve the quality of this
review.
DATES: Submission Deadline on or before February 13, 2025.
ADDRESSES:
Email submissions: <a href="/cdn-cgi/l/email-protection#a8cdd8cbe8c9c0dad986c0c0db86cfc7de"><span class="__cf_email__" data-cfemail="1f7a6f7c5f7e776d6e3177776c31787069">[email protected]</span></a>.
Print submissions:
Mailing Address: Center for Evidence and Practice Improvement, Agency
for Healthcare Research and Quality, ATTN: EPC SEADs Coordinator, 5600
Fishers Lane, Mail Stop 06E53A, Rockville, MD 20857
Shipping Address (FedEx, UPS, etc.): Center for Evidence and Practice
Improvement, Agency for Healthcare Research and Quality, ATTN: EPC
SEADs Coordinator, 5600 Fishers Lane, Mail Stop 06E77D, Rockville, MD
20857
FOR FURTHER INFORMATION CONTACT: Kelly Carper, Telephone: 301-427-1656
or Email: <a href="/cdn-cgi/l/email-protection#f1948192b190998380df999982df969e87"><span class="__cf_email__" data-cfemail="0560756645646d77742b6d6d762b626a73">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: The Agency for Healthcare Research and
Quality has commissioned the Evidence-based Practice Centers (EPC)
Program to complete a review of the evidence for The Performance of
Fusion Procedures for Degenerative Disease of the Lumbar Spine. AHRQ is
conducting this review pursuant to Section 902 of the Public Health
Service Act, 42 U.S.C. 299a.
The EPC Program is dedicated to identifying as many studies as
possible that are relevant to the questions for each of its reviews. In
order to do so, we are supplementing the usual manual and electronic
database searches of the literature by requesting information from the
public (e.g., details of studies conducted). We are looking for studies
that report on The Performance of Fusion Procedures for Degenerative
Disease of the Lumbar Spine. The entire research protocol is available
online at: <a href="https://effectivehealthcare.ahrq.gov/products/lumbar-spinal-fusion/protocol">https://effectivehealthcare.ahrq.gov/products/lumbar-spinal-fusion/protocol</a>.
This is to notify the public that the EPC Program would find the
following information on The Performance of Fusion Procedures for
Degenerative Disease of the Lumbar Spine helpful:
[ssquf] A list of completed studies that your organization has
sponsored for this topic. In the list, please indicate whether results
are available on <a href="http://ClinicalTrials.gov">ClinicalTrials.gov</a> along with the <a href="http://ClinicalTrials.gov">ClinicalTrials.gov</a>
trial number.
[ssquf] For completed studies that do not have results on
<a href="http://ClinicalTrials.gov">ClinicalTrials.gov</a>, a summary, including the following elements, if
relevant: study number, study period, design, methodology, indication
and diagnosis, proper use instructions, inclusion and exclusion
criteria, primary and secondary outcomes, baseline characteristics,
number of patients screened/eligible/enrolled/lost to follow-up/
withdrawn/analyzed, effectiveness/efficacy, and safety results.
[ssquf] A list of ongoing studies that your organization has
sponsored for this topic. In the list, please provide the
<a href="http://ClinicalTrials.gov">ClinicalTrials.gov</a> trial number or, if the trial is not registered, the
protocol for the study including, if relevant, a study number, the
study period, design, methodology, indication and diagnosis, proper use
instructions, inclusion and exclusion criteria, and primary and
secondary outcomes.
[ssquf] Description of whether the above studies constitute ALL
Phase II and above clinical trials sponsored by your organization for
this topic and an index outlining the relevant information in each
submitted file.
Your contribution is very beneficial to the Program. Materials
submitted must
[[Page 3215]]
be publicly available or able to be made public. Materials that are
considered confidential; marketing materials; study types not included
in the review; or information on topics not included in the review
cannot be used by the EPC Program. This is a voluntary request for
information, and all costs for complying with this request must be
borne by the submitter.
The draft of this review will be posted on AHRQ's EPC Program
website and available for public comment for a period of 4 weeks. If
you would like to be notified when the draft is posted, please sign up
for the email list at: <a href="https://effectivehealthcare.ahrq.gov/email-updates">https://effectivehealthcare.ahrq.gov/email-updates</a>.
The review will answer the following questions. This information is
provided as background. AHRQ is not requesting that the public provide
answers to these questions.
Key Questions (KQ)
Questions on Surgery (KQ 1-4)
In adults with symptomatic, stable degenerative lumbar
spondylolisthesis (DLS) with or without radiculopathy or neurogenic
claudication
<bullet> Key Question 1. What are the benefits and harms of surgery
with instrumentation in addition to decompression compared with
decompression alone?
In symptomatic adults with unstable or stable DLS with or without
radiculopathy or neurogenic claudication undergoing instrumented
fusion:
<bullet> Key Question 2. What are the benefits and harms of the
addition of an interbody cage to instrumentation (e.g., pedicle screws)
compared to use of instrumentation alone (i.e., posterolateral fusion)?
<bullet> Key Question 3. What are the benefits and harms of the use
of bone graft extenders and biologic substitutes compared to the use of
autografts?
In adults with symptomatic, degenerative lumbar spine disease
undergoing instrumented fusion:
<bullet> Key Question 4. Does the use of intraoperative monitoring
(IONM) decrease perioperative neurological injuries compared with not
using IONM?
PICOTS (Populations, Interventions, Comparators, Outcomes, Timing, and
Setting)
Table 1--EPC Proposed PICOTS and Corresponding Inclusion and Exclusion Criteria Key Questions 1,2,3 and 4 on
Surgery
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Inclusion Exclusion
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Population....................... Key Questions (1-3) ALL Key Questions
<bullet> Symptomatic adult patients <bullet> Patients <18 years old.
with a radiographic diagnosis (based <bullet> Asymptomatic patients.
on dynamic (flexion and extension <bullet> Other forms of
radiographs) of degenerative lumbar spondylolisthesis are excluded
spondylolisthesis (any grade) who (i.e., excluding dysplastic,
remain symptomatic following isthmic, traumatic, and pathologic
conservative treatment causes/forms).
<bullet> Patients with or without <bullet> Patients with osteoporosis,
evidence of nerve compression vertebral compression fractures.
(radiculopathy, neurogenic <bullet> Exclude pts undergoing
claudication) revisions or repeat procedures.
KQ 1 <bullet> Patients having reoperation/
<bullet> Stable (non-mobile, static) repeat procedures.
DLS (<3 mm slip on extension/flexion KQs 1-3
radiographs) <bullet> Patients without
KQ 2, 3 degenerative spondylolisthesis.
<bullet> Patients with unstable or <bullet> Studies with <80% of
stable DLS on radiographs patients have spondylolisthesis.
KQ 4 KQ 1
<bullet> Patients with symptomatic <bullet> Patients with unstable
degenerative lumbar spine disease (dynamic) DLS: (exclude study if
undergoing fusion of 5 or fewer stable is not specified, is
levels (stratify by presence of DLS) unclear).
Interventions.................... ALL Key Questions ALL Key Questions
<bullet> FDA approved devices or <bullet> Devices or materials that
materials (or in Phase III trials) as are not FDA approved or in Phase III
applicable to the KQ trials (as applicable to the
<bullet> Open and minimally invasive question) or not available in the
(e.g., endoscopic) procedures U.S.
KQ 1 <bullet> Mesenchymal stem cells
<bullet> Decompression (discectomy, (MSCs)
indirect and direct methods) with <bullet> Procedures that don't
instrumented spinal fusion (e.g., include decompression
with pedicle screws, interbody cages, <bullet> Non-instrumented fusions
or other hardware) <bullet> Coflex, interspinous
KQ 2 fixation
<bullet> Surgical decompression and <bullet> Minimally invasive lumbar
instrumented posterolateral fusion decompression (MILD) procedure
(e.g., using pedicle screws) with <bullet> Surgical procedures not
addition of interbody cage listed
(expandable or static, ALIF, TLIF, KQ 4
LLIF) <bullet> Other monitoring formats
KQ 3 (e.g., imaging, computer assisted
<bullet> Decompression and spinal navigation systems, etc.)
fusion using bone graft extenders or <bullet> Combinations of graft
biologic substitutes (demineralized materials (other than with
bone matrix, cadaveric allograft, autograft)
cortical fibers, bone morphogenic <bullet> Comparison of graft
protein, cellular allografts materials with each other
KQ 4
<bullet> IONM (Motor Evoked Potentials
(MEP), Somatosensory Evoked
Potentials (SSEP), Free Running EMG
(electromyography) Direct Stimulation
[[Page 3216]]
Comparators...................... ALL Key Questions ALL Key Questions
<bullet> FDA approved devices or <bullet> Conservative care, non-
materials (or in Phase III trials) as operative care, usual care
applicable to the KQ <bullet> Devices or materials that
<bullet> Open and minimally invasive are not FDA approved or in Phase III
(e.g., endoscopic) procedures trials (as applicable to the
KQ 1 question) or not available in the
<bullet> Decompression alone U.S.
KQ 2 <bullet> Mesenchymal stem cells
<bullet> Decompression and (MSCs)
instrumented posterolateral spinal KQ 1
fusion (e.g., using pedicle screws <bullet> Other surgical procedures
alone) KQ 2, 3
KQ 3 <bullet> Non-instrumented fusion,
<bullet> Decompression and <bullet> Instrumentation prior to
instrumented spinal fusion using 2000
autograft <bullet> Coflex, interspinous
KQ 4 fixation
<bullet> No use of IONM KQ 3
<bullet> Combinations of graft
materials with autograft
Outcomes......................... ALL Key Questions ALL Key Questions
<bullet> Validated measures for pain <bullet> Measures of pain, function
and symptoms that are not validated
[cir] Pain (e.g., VAS) <bullet> Measures/outcomes not listed
[cir] Function (e.g., ODI) <bullet> Radiographic parameters
[cir] Quality of Life (e.g., SF-36, SF- (e.g., evidence of global spinal
12) alignment)
<bullet> Peri- and post-operative
harms (including serious AEs/harms,
persistent pain, sacro-iliac joint
pain, instrument failure)
Additional outcomes by KQ
KQ 1: Reoperation rates
KQ 2: Fusion (arthrodesis) rates
KQ 3: Fusion (arthrodesis) rates
KQ 4: Persistent neurological damage
based on clinical exam (e.g., foot
drop)
Timing........................... Key Questions 1-3 KQ 1
<bullet> Pain, function, reoperation: <bullet> Re-operation beyond 12
3, 6 and >=12 months (up to 60 months
months) KQs 1-3
<bullet> Reoperation-any time (KQ 2): <bullet> Outcomes measured less than
<bullet> Harms: any time 3 months (except harms)
KQ 4 KQ 4
<bullet> Any time during post- <bullet> Alerts and responses to
operative followup alerts during surgery
Settings......................... ALL Key Questions .....................................
<bullet> Inpatient care followed by
care in specialty and primary care
clinics
<bullet> Outpatient ambulatory surgery
centers
Study designs.................... ALL Key Questions ALL Key Questions
<bullet> RCTs for effectiveness/ <bullet> NRSI that do not control for
efficacy outcomes confounding
<bullet> FDA SSED if there is <bullet> NRSI that include historical
inadequate information from published controls
studies <bullet> NRSI of treatment with fewer
<bullet> Studies published in 2000 or than 50 patients per treatment arm
later <bullet> Case reports, case-series,
KQ 1-3: NRSIs will be considered for single-arm and pre-post studies
harms only and must be specifically <bullet> Publication types:
designed to evaluate/report on AE/ Conference abstracts or proceedings,
harms and control for confounding and editorials, letters, white papers,
focused on rare or long-term harms. citations that have not been peer-
KQ 4: NRSIs on effectiveness and harms reviewed, single site reports of
multi-site studies
<bullet> Studies published prior to
2000
<bullet> Studies not in English
KQ 1-3
<bullet> Trials with fewer than 15
patients per treatment arm
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Serious adverse events are defined as events that are life-threatening or require additional medical attention.
AE = adverse event; ALIF = anterior lumbar interbody fusion; DLS = degenerative lumbar spondylolisthesis; EQ-
5D = EuroQol 5D scale; FDA = Food and Drug Administration; IONM = intraoperative neurological monitoring; KQ =
Key Question; LLIF = lateral lumbar interbody fusion; MCID = minimum clinically important difference; NRSI =
nonrandomized studies of intervention; ODI = Oswestry Disability Index; RCT = randomized controlled trial; RMD
= Roland-Morris Disability Questionnaire; SSED = Summary of Safety and Effectiveness Data; SF-36/12 = Short
Form 36 or 12 questionnaire; TLIF = transforaminal lumbar interbody fusion; U.S. = United States; VAS = visual
analog scale.
KQ 5 and 6: Questions on Non-Surgical Procedures for Chronic Low Back
Pain Due To Degenerative Spine Disease
Key Question 5. In adult patients with chronic low-back pain (>=3
months) resulting from degenerative disease what are the benefits and
harms of lumbar epidural steroid injections, intra-articular (facet)
injection, medial branch blocks, or radio frequency ablation?
Key Question 6. In adult patients with chronic low-back pain (>=3
months) resulting from degenerative disease of the lumbar spine, does
symptomatic improvement to therapeutic challenge with lumbar epidural
steroid injections, intra-articular (facet) injection, medial branch
blocks or radio frequency ablation predict positive outcomes after
lumbar fusion surgery?
Special populations and factors for Key Questions 5 and 6: Age,
sex, BMI, presence of psychological comorbidities, presence of medical
comorbidities, baseline pain severity, presence and type of concomitant
degenerative lumbar spine disease, presence and severity of DLS.
[[Page 3217]]
Table 2--EPC Proposed PICOTS and Corresponding Inclusion and Exclusion Criteria: Key Questions 5 and 6 on
Specific Procedures in Patients With Chronic Low Back Pain Due To Degenerative Spine Disease
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Inclusion Exclusion
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Population....................... KQ 5, 6 KQ 5, 6
<bullet> Adult patients with chronic <bullet> Patients with acute or
low-back pain (>=3 months duration) subacute LBP
resulting from degenerative disease <bullet> Patients with disc
herniation
<bullet> Patients with failed back
surgery syndrome
<bullet> Sacroiliac pain
<bullet> Patients having reoperation
Interventions.................... KQ 5, 6 KQ 5, 6
<bullet> Epidural steroid injections <bullet> Discoblock, provocative
(ESI) discography
<bullet> Intra-articular (facet) <bullet> Neuromodulation (e.g.,
injections spinal cord, dorsal column, dorsal
<bullet> Radiofrequency Ablation (RFA) root stimulation, peripheral nerve
<bullet> Medial branch blocks stimulation)
<bullet> Injections: exclude other
biologics (e.g., PRP), intradiscal
injections
<bullet> Minimally invasive lumbar
decompression (MILD), percutaneous
decompression
<bullet> Selective nerve root blocks
<bullet> Intraosseous basivertebral
nerve ablation
<bullet> Combinations of procedures;
Studies evaluating additive benefits
of one procedure with another
Comparators...................... KQ 5 KQ 5, 6
<bullet> Other nonoperative treatment, <bullet> Combinations of procedures;
no treatment, sham Studies evaluating additive benefits
KQ 6 of one procedure to another
<bullet> No therapeutic challenge; KQ 5
(prognostic/predictive modeling <bullet> For ESI, exclude comparison
study) with disc procedures (e.g.,
discography); comparisons of
medications
<bullet> For RFA exclude comparisons
of different types of neurotomy
(conventional vs. pulsed [cooled]
RF; RF vs. alcohol ablation)
Outcomes......................... KQ 5 and 6: Harms (e.g., serious peri- KQ 5, 6
procedural and post-procedural harms) <bullet> Measures of pain, function
KQ 5 that are not validated
<bullet> Validated measures for pain <bullet> Measures/outcomes not listed
and symptoms
[cir] Pain (e.g., VAS, NRS)
[cir] Function (e.g., ODI)
[cir] Quality of Life (e.g., SF-36,
SF12)
KQ 6
<bullet> Response to challenge:
Improvement in symptoms vs. non-
improvement; [stratify other outcomes
by response]
<bullet> Validated measures for pain
and symptoms following fusion surgery
[cir] Pain (e.g., VAS, NRS)
[cir] Function (e.g., ODI)
[cir] Quality of Life (e.g., SF-36, SF-
12)
[cir] Symptoms associated with neural
compression
<bullet> Successful arthrodesis [as
radiographically determined via x-ray/
computed tomography or by proxy
(e.g., lack of revision, pedicle
screw loosening)]
Timing........................... KQ 5 and 6
<bullet> Serious harms--periprocedural
KQ 5
<bullet> 3-month and 6-month periods
following the procedure
KQ 6
<bullet> Outcomes measured at 3, 6 and
>=12 months after surgical procedure
(up to 24 months)
Settings......................... KQ 5
<bullet> Outpatient
KQ 6
<bullet> Outpatient care for
therapeutic challenge. Inpatient care
followed by care in specialty and
primary care clinics for surgical
procedure
<bullet> Outpatient ambulatory surgery
centers for surgery
[[Page 3218]]
Study designs.................... KQ 5 KQ 5, 6
<bullet> RCTS for effectiveness/ <bullet> NRSI that do not control for
efficacy outcomes confounding
<bullet> Prospective NRSIs that <bullet> NRSI that include historical
control for confounding will be controls
considered for effectiveness in the <bullet> NRSI with fewer than 50
absence of RCTs patients per treatment arm
<bullet> NRSIs for harms must be <bullet> Case reports, case-series,
specifically designed to evaluate/ single-arm and pre-post studies
report on serious AE/harms and that <bullet> Publication types:
control for confounding OR focused on Conference abstracts or proceedings,
rare or long-term harms editorials, letters, white papers,
KQ 6 citations that have not been peer-
<bullet> Predictive/prognostic reviewed, single site reports of
modeling studies evaluating the multi-site studies
association of procedure response <bullet> Studies not in English
impact on outcomes that control for
confounding
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Serious adverse events are defined as events that are life-threatening or anything needing additional medical
attention. AE = adverse event; DLS = degenerative lumbar spondylolisthesis; EQ-5D = EuroQol 5D scale; ESI =
epidural steroid injection; FDA = Food and Drug Administration; IONM = intraoperative neuro monitoring; KQ =
Key Question; LBP = low back pain; MCID = minimum clinically important difference; NRSI = nonrandomized
studies of intervention; ODI = Oswestry Disability Index; RCT = randomized controlled trial; RF =
radiofrequency ablation; RMD = Rolland-Morris Disability Questionnaire; SSED = Summary of Safety and
Effectiveness Data; SF-36/12 = Short Form 36 or 12 questionnaire; VAS = visual analog scale.
Dated: January 7, 2025.
Marquita Cullom,
Associate Director.
[FR Doc. 2025-00548 Filed 1-13-25; 8:45 am]
BILLING CODE 4160-90-P
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