# 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.
**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 Access to published and unpublished pertinent scientific information will improve the quality of this review.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: [email protected].*
*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: *[email protected].*
**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: *https://effectivehealthcare.ahrq.gov/products/lumbar-spinal-fusion/protocol.*
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:
A list of completed studies that your organization has sponsored for this topic. In the list, please *indicate whether results are available on ClinicalTrials.gov along with the ClinicalTrials.gov trial number.*
*For completed studies that do not have results on ClinicalTrials.gov,* 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.
*A list of ongoing studies that your organization has sponsored for this topic.* 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 *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 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: *https://effectivehealthcare.ahrq.gov/email-updates.*
*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
• *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:
• *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)?
• *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:
• 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)**
| | Inclusion | Exclusion |
| --- | --- | --- |
| Population | Key Questions (1-3) | ALL Key Questions |
| Interventions | ALL Key Questions | ALL Key Questions |
| Comparators | ALL Key Questions | ALL Key Questions |
| Outcomes | ALL Key Questions | ALL Key Questions |
| Timing | Key Questions 1-3 | KQ 1 |
| Settings | ALL Key Questions | |
| Study designs | ALL Key Questions | ALL Key Questions |
**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.
| | Inclusion | Exclusion |
| --- | --- | --- |
| Population | KQ 5, 6 | KQ 5, 6 |
| Interventions | KQ 5, 6 | KQ 5, 6 |
| Comparators | KQ 5 | KQ 5, 6 |
| Outcomes | KQ 5 and 6: Harms (
serious peri-procedural and post-procedural harms) | KQ 5, 6 |
| Timing | KQ 5 and 6 | |
| Settings | KQ 5 | |
| Study designs | KQ 5 | KQ 5, 6 |
Dated: January 7, 2025.
Marquita Cullom,
Associate Director.