Supplemental Evidence and Data Request on The Performance of Fusion Procedures for Degenerative Disease of the Lumbar Spine

<NOTICE> DEPARTMENT OF HEALTH AND HUMAN SERVICES <SUBAGY>Agency for Healthcare Research and Quality</SUBAGY> <SUBJECT>Supplemental Evidence and Data Request on The Performance of Fusion Procedures for Degenerative Disease of the Lumbar Spine</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Agency for Healthcare Research and Quality (AHRQ), HHS. <HD SOURCE="HED">ACTION:</HD> Request for Supplemental Evidence and Data Submission. <SUM> <HD SOURCE="HED">SUMMARY:</HD> 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 <E T="03">The Performance of Fusion Procedures for Degenerative Disease of the Lumbar Spine,</E> 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 Access to published and unpublished pertinent scientific information will improve the quality of this review. </SUM> <DATES> <HD SOURCE="HED">DATES:</HD> <E T="03">Submission Deadline</E> on or before February 13, 2025. </DATES> <HD SOURCE="HED">ADDRESSES:</HD> <E T="03">Email submissions: epc@ahrq.hhs.gov.</E> <E T="03">Print submissions:</E> <FP SOURCE="FP-1"> <E T="03">Mailing Address:</E> 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 </FP> <FP SOURCE="FP-1"> <E T="03">Shipping Address (FedEx, UPS, etc.):</E> 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 </FP> <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> Kelly Carper, Telephone: 301-427-1656 or Email: <E T="03">epc@ahrq.hhs.gov.</E> </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> The Agency for Healthcare Research and Quality has commissioned the Evidence-based Practice Centers (EPC) Program to complete a review of the evidence for <E T="03">The Performance of Fusion Procedures for Degenerative Disease of the Lumbar Spine.</E> 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 T="03">e.g.,</E> details of studies conducted). We are looking for studies that report on <E T="03">The Performance of Fusion Procedures for Degenerative Disease of the Lumbar Spine.</E> The entire research protocol is available online at: <E T="03">https://effectivehealthcare.ahrq.gov/products/lumbar-spinal-fusion/protocol.</E> This is to notify the public that the EPC Program would find the following information on <E T="03">The Performance of Fusion Procedures for Degenerative Disease of the Lumbar Spine</E> helpful: A list of completed studies that your organization has sponsored for this topic. In the list, please <E T="03">indicate whether results are available on ClinicalTrials.gov along with the ClinicalTrials.gov trial number.</E> <E T="03">For completed studies that do not have results on ClinicalTrials.gov,</E> 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. <E T="03">A list of ongoing studies that your organization has sponsored for this topic.</E> In the list, please provide the ClinicalTrials.gov 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. Description of whether the above studies constitute <E T="03">ALL Phase II and above clinical trials</E> 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 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: <E T="03">https://effectivehealthcare.ahrq.gov/email-updates.</E> <E T="03">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.</E> <HD SOURCE="HD1">Key Questions (KQ)</HD> <HD SOURCE="HD2">Questions on Surgery (KQ 1-4)</HD> In adults with symptomatic, stable degenerative lumbar spondylolisthesis (DLS) with or without radiculopathy or neurogenic claudication • <E T="03">Key Question 1.</E> 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: • <E T="03">Key Question 2.</E> What are the benefits and harms of the addition of an interbody cage to instrumentation ( <E T="03">e.g.,</E> pedicle screws) compared to use of instrumentation alone ( <E T="03">i.e.,</E> posterolateral fusion)? • <E T="03">Key Question 3.</E> 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: • Key Question 4. Does the use of intraoperative monitoring (IONM) decrease perioperative neurological injuries compared with not using IONM? <HD SOURCE="HD1">PICOTS (Populations, Interventions, Comparators, Outcomes, Timing, and Setting)</HD> <GPOTABLE COLS="3" OPTS="L2,nj,p7,7/8,i1" CDEF="s100,xl100,xl100"> <TTITLE>Table 1—EPC Proposed PICOTS and Corresponding Inclusion and Exclusion Criteria Key Questions 1,2,3 and 4 on Surgery</TTITLE> <CHED H="1"> </CHED> <CHED H="1">Inclusion</CHED> <CHED H="1">Exclusion</CHED> <ROW> <ENT I="01">Population</ENT> <ENT> Key Questions (1-3) • Symptomatic adult patients with a radiographic diagnosis (based on dynamic (flexion and extension radiographs) of degenerative lumbar spondylolisthesis (any grade) who remain symptomatic following conservative treatment • Patients with or without evidence of nerve compression (radiculopathy, neurogenic claudication) KQ 1 • Stable (non-mobile, static) DLS (<3 mm slip on extension/flexion radiographs) KQ 2, 3 • Patients with unstable or stable DLS on radiographs KQ 4 • Patients with symptomatic degenerative lumbar spine disease undergoing fusion of 5 or fewer levels (stratify by presence of DLS) </ENT> <ENT> ALL Key Questions • Patients <18 years old. • Asymptomatic patients. • Other forms of spondylolisthesis are excluded ( <E T="03">i.e.,</E> excluding dysplastic, isthmic, traumatic, and pathologic causes/forms). • Patients with osteoporosis, vertebral compression fractures. • Exclude pts undergoing revisions or repeat procedures. • Patients having reoperation/repeat procedures. KQs 1-3 • Patients without degenerative spondylolisthesis. • Studies with <80% of patients have spondylolisthesis. KQ 1 • Patients with unstable (dynamic) DLS: (exclude study if stable is not specified, is unclear). </ENT> </ROW> <ROW> <ENT I="01">Interventions</ENT> <ENT> ALL Key Questions • FDA approved devices or materials (or in Phase III trials) as applicable to the KQ • Open and minimally invasive ( <E T="03">e.g.,</E> endoscopic) procedures KQ 1 • Decompression (discectomy, indirect and direct methods) with instrumented spinal fusion ( <E T="03">e.g.,</E> with pedicle screws, interbody cages, or other hardware) KQ 2 • Surgical decompression and instrumented posterolateral fusion ( <E T="03">e.g.,</E> using pedicle screws) with addition of interbody cage (expandable or static, ALIF, TLIF, LLIF) KQ 3 • Decompression and spinal fusion using bone graft extenders or biologic substitutes (demineralized bone matrix, cadaveric allograft, cortical fibers, bone morphogenic protein, cellular allografts KQ 4 • IONM (Motor Evoked Potentials (MEP), Somatosensory Evoked Potentials (SSEP), Free Running EMG (electromyography) Direct Stimulation </ENT> <ENT> ALL Key Questions • Devices or materials that are not FDA approved or in Phase III trials (as applicable to the question) or not available in the U.S. • Mesenchymal stem cells (MSCs) • Procedures that don't include decompression • Non-instrumented fusions • Coflex, interspinous fixation • Minimally invasive lumbar decompression (MILD) procedure • Surgical procedures not listed KQ 4 • Other monitoring formats ( <E T="03">e.g.,</E> imaging, computer assisted navigation systems, etc.) • Combinations of graft materials (other than with autograft) • Comparison of graft materials with each other </ENT> ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 20k characters. 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