Agency for Healthcare Quality and Research (AHRQ)

Proposed Research Title for the Topic:
Spinal Fusion for Painful Lumbar Degenerative Disc or Joint Disease

Comments submitted on behalf of
International Society for the Advancement of Spine Surgery (ISASS)

Jean Charles LeHuec, MD, PhD – President
2323 Cheshire Drive, Suite 101
Aurora, IL 60502
630-995-9994
www.isass.org

Introductory Statement

ISASS is an international, scientific and educational society organized to discuss and assess existing strategies and innovative ideas in the clinical and basic sciences related to spine surgery to enhance patient care. ISASS’ membership based is comprised of orthopaedic surgeons, neurosurgeons, and and researchers dedicated to improving patient care through medically appropriate spinal surgeries.

We welcome the opportunity to comment on the key questions AHRQ might pose as they undertake a review of spinal fusion for lumbar degenerative disc or joint disease. As a scientific, educational and advocacy organization, we remain committed to insure that subsequent AHRQ recommendations around lumbar spinal fusions for degenerative disc or joint disease do not unfairly or unnecessarily limit patient access to medically indicated surgeries that can improve patient outcomes, reduce or eliminate chronic pain, and accelerate a patient’s return to a satisfying and productive life.

First and foremost, we are concerned about the inaccuracy and simplicity of AHRQ’s assumption that all patients are identical; nothing could be further from the truth. Almost all cultures have recognized the idiom, comparing apples and oranges to refer to the incomparable difference between items which are by definition incommensurate. This false analogy is compounded or faulted further when one recognizes that not all apples (or oranges) are alike.  A bucket of homogeneous patients is not reflective of how patients actually present with spinal conditions. This very fact significantly impacts the study outcome inclusion/exclusion criteria systematic review that is now requested by governments/insurers to validate spinal treatment protocols.  More specific articulated questions are welcomed by ISASS and will generally receive specific clinically relevant responses.

Finally, in addition to our comments to AHRQ’s specific questions, below, we have attached to this document our society’s2011 Policy Statement on Lumbar Fusion Surgeries, which articulates, based on the current literature, when lumbar fusion surgeries are medically appropriate. This document contains a section specific to degenerative disc disease (see page 3, and pages 7-9). An excerpt from this Policy Statement reads: “On the whole, the body of scientific evidence consistently supports the use of fusion for lumbar DDD.  However, the available research and further scientific discussion have also made it clear that the question of whether or not fusion should be used for lumbar DDD is far from having a simple ‘yes or no’ answer for all cases, as it does in most other diagnoses.  Patient selection and the treatment algorithm require careful consideration of numerous details and secondary findings from the research literature, of which most people do not have a clear and comprehensive overview.”

ISASS welcomes an opportunity for direct, face-to-face dialogue with the AHRQ to review the conditions for medically appropriate lumbar fusions for DDD and other indications, and to inform policy recommendations that do not restrict appropriate patient access to medically indicated surgeries for patients suffering low back attributable to degenerative disk disease.

Comments on Key Questions posed by the Agency for Healthcare Quality and Research (AHRQ)

Comments specific to Qs 1-3 – there is concern with using non-operative therapies as a comparator for fusion; if the patient fails, why is that a comparator?  Additionally, these questions do not identify all the tell-tale symptoms associated with DDD, nor do they account for concommitant diagnoses of other symptoms, but rather simply try to compare a surgical solution to a non-operative solution without articulating the different symptoms that may necessitate surgery vs. non-surgery.

1. For adults with low back pain attributed to degenerative disc disease of the lumbar spine, does spinal fusion differ from nonoperative treatment in the ability to improve: 

a. Patient-centered outcomes such as function, quality of life, or pain?

Yes; Spinal Fusion and Nonoperative treatment are both valuable tools in the treatment of symptomatic degenerative discs when the pain is due to inflammatory, mechanical or neurological causes. Each modality has specific indications and they should not be considered mutually exclusive treatment;  it is not one versus the other, but rather, both have distinct indications for use, and both have distinct expected outcomes.

b. Adverse events?

Yes there is a difference in the adverse events associated with fusion versus nonoperative management. However you cannot compare the modalities with respect to adverse events as each differ in type of adverse events and rate of adverse events and consequences of adverse events.

[An alternative question 1 might read as follows: “In your practice population, what patient characteristics must present themselves in order to determine spinal fusion over nonoperative treatment or vice versa as the most appropriate method for treatment?

a. How have you seen patient-centered outcomes such as function, quality of life, or pain differ based on these patient outcomes?

b. How are the adverse events affected by these patient characteristics?]

2. For adults with low back pain attributed to degenerative (not congenital) stenosis of the lumbar spine, does spinal fusion differ from nonoperative treatment in the ability to improve:

a. Patient-centered outcomes such as function, quality of life, or pain?

Absolutely, there is a difference in patient centered outcomes; Spinal Fusion and Nonoperative treatment are both valuable tools in the treatment of symptomatic spinal stenosis when the pain is due to inflammatory, mechanical or neurological causes. Each modality has specific indications and should not be considered mutually exclusive; it is not one versus the other,and we must acknowledge that both have distinct indications for use, both have distinct expected outcomes,  in addition, the principal surgical treatment for spinal stenosis is a direct or indirect decompression of the neurological elements; fusion is the secondary adjunct procedure if deformity or instability exists.

b. Adverse events?

Yes, there is a difference in the adverse events associated with fusion versus nonoperative management in the treatment of symptomatic spinal stenosis. However, you cannot compare the modalities with respect to adverse events, as each differ in type of adverse events and rate of adverse events and consequences of adverse events.

3. For adults with low back pain attributed to degenerative spondylolisthesis of the lumbar spine, does spinal fusion differ from nonoperative treatment in the ability to improve:

a. Patient-centered outcomes such as function, quality of life, or pain?

Absolutely, there is a difference in patient centered outcomes. Spinal Fusion and Nonoperative treatment are both valuable tools in the treatment of symptomatic degenerative spondylolisthesis when the pain is due to inflammatory, mechanical or neurological causes; each modality has specific indications and should not be considered mutually exclusive. It is not one versus the other, but rather, both have distinct indications for use, and both have distinct expected outcomes; in addition, the principal surgical treatment for degenerative spondylolisthesis is a direct or indirect decompression of the neurological elements accompanied by a fusion procedure if deformity or instability exists. 

b. Adverse events?

Yes, there is a difference in the adverse events associated with fusion versus nonoperative management in the treatment of symptomatic degenerative spondylolisthesis; however, you cannot compare the modalities with respect to adverse events as each differ in type of adverse events and rate of adverse events and consequences of adverse events.

[COMMENTS ABOUT Qs 4-6 – Are these the best comparators? Yes, perhaps for total disc replacement, but the others may not be fair comparisons. Also, with some of these diagnoses, there are differing grades of severity, some requiring surgery, others not. Not all spondes, for example, are the same.]

4. For adults with low back pain attributed to degenerative disc disease of the lumbar spine, does spinal fusion differ from other spinal procedures (e.g., total disc replacement, disc decompression) in the ability to improve:

a. Perioperative outcomes such as surgery time, blood loss, or length of hospital stay?

Yes, Spinal Fusion and Disc Replacement are similar in most regards; however, they do have subtle differences in perioperative outcomes due to the nature of the surgical exposure. Each treatment has specific indications for use, and both have distinct expected perioperative outcomes.  Disc Decompression has not been shown to be a valuable treatment.

b. Patient-centered outcomes such as function, quality of life, or pain?

Yes, there is a difference in patient centered outcomes. Spinal Fusion and Disc Replacement are both valuable tools in the treatment of symptomatic degenerative discs when the pain is due to inflammatory, mechanical or neurological causes; each treatment has specific indications for use, both have distinct expected outcomes. Disc Decompression has not been shown to be a valuable treatment.

c. Adverse events?

Yes, there is a difference in the ability to improve adverse events associated with Spinal Fusion versus Disc Replacement in the treatment of symptomatic degenerative discs; however, you cannot directly compare the modalities with respect to adverse events, as each differ in type of adverse events and rate of adverse events and consequences of adverse events.

5. For adults with low back pain attributed to degenerative stenosis of the lumbar spine, does spinal fusion differ from other spinal procedures (e.g., decompressive laminectomy and minimally invasive procedures, including those using devices) in the ability to improve:

a. Perioperative outcomes such as surgery time, blood loss, or length of hospital stay?

Yes, there is a difference in ability to improve perioperative outcomes. The principal surgical treatment for spinal stenosis is a direct or indirect decompression of the neurological elements (e.g., decompressive laminectomy, laminotomy). Fusion is the secondary adjunct procedure if deformity or instability exists. The use of indirect spinous process distraction devices is currently unproven.

b. Patient-centered outcomes such as function, quality of life, or pain?

Yes, there is a difference in ability to improve patient centered outcomes. The principal surgical treatment for spinal stenosis is a direct or indirect decompression of the neurological elements (e.g., decompressive laminectomy, laminotomy). Fusion is the secondary adjunct procedure if deformity or instability exists, however you cannot compare the modalities with respect to outcomes, as each have unique indications and differ in expected outcome. The use of indirect spinous process distraction devices is currently unproven.

c. Adverse events?

Yes there is a difference in the ability to improve adverse events associated with fusion versus other spinal procedures; however you cannot compare the modalities with respect to adverse events, as each differ in type of adverse events and rate of adverse events and consequences of adverse events. The use of indirect spinous process distraction devices is currently unproven.

6. For adults with low back pain attributed to spondylolisthesis of the lumbar spine, does spinal fusion differ from other spinal procedures (e.g., repair, vertebrectomy) in the ability to improve:

a. Perioperative outcomes such as surgery time, blood loss, or length of hospital stay?

Yes, there is a difference in ability to improve perioperative outcomes. The principal surgical treatment for degenerative spondylolisthesis is a direct or indirect decompression of the neurological elements, accompanied by a fusion procedure if deformity or instability exists, Each modality has specific indications and should not be considered mutually exclusive; it is not one versus the other, as all have distinct indications for use and distinct expected outcomes.

b. Patient-centered outcomes such as function, quality of life, or pain?

Yes, there is a difference in ability to improve patient centered outcomes. The principal treatment for degenerative spondylolisthesis is a direct or indirect decompression of the neurological elements accompanied by a fusion procedure if deformity or instability exists. Other spinal procedures (e.g. repair, vertebrectomy) may likewise be valuable as adjuncts to the principal procedure; however, you cannot compare the modalities with respect to outcomes as each have unique indications and differ in expected outcomes.

c. Adverse events?

Yes there is a difference in the ability to improve adverse events associated with fusion versus other spinal procedures; however, you cannot compare the modalities with respect to adverse events, as each differ in type of adverse events and rate of adverse events and consequences of adverse events.

7. For adults with low back pain attributed to degenerative disc disease of the lumbar spine, do spinal fusion approaches (e.g., anterior, posterior, combined) and techniques (e.g., instrumentation or graft material) differ in the ability to improve:

a. Perioperative outcomes such as surgery time, blood loss, or length of hospital stay?

Yes, there is a difference in ability to improve perioperative outcomes with differing spinal fusion approaches; spinal fusion approaches differ in their indications and expected outcomes – approaches are typically selected on the basis of the level of the spine to be accessed and the required operative intervention; therefore you cannot directly compare the various approaches with respect to outcomes, as each have unique indications and differ in expected outcome.

b. Patient-centered outcomes such as function, quality of life, or pain?

Yes, there is a difference in ability to improve patient centered outcomes; spinal fusion approaches differ in their indications and expected outcomes – approaches are typically selected on the basis of the level of the spine to be accessed and the required operative intervention; therefore you cannot directly compare the various approaches with respect to outcomes, as each have unique indications and differ in expected outcome.

c. Adverse events?

Yes, there is a difference in the ability to improve adverse events associated with spinal fusion approaches; however, you cannot compare the various approaches with respect to adverse events, as each differ in type of adverse events and rate of adverse events and consequences of adverse events.

8. For adults with low back pain attributed to degenerative stenosis of the lumbar spine, do spinal fusion approaches (e.g., anterior, posterior, combined) and techniques (e.g., instrumentation or graft material) differ in the ability to improve:

a. Perioperative outcomes such as surgery time, blood loss, or length of hospital stay?

Yes, there is a difference in ability to improve perioperative outcomes with differing spinal fusion approaches and techniques in treating degenerative stenosis; spinal fusion approaches and techniques differ in their indications and expected outcomes. Approaches and techniques are typically selected on the basis of the level of the spine to be accessed and the required operative intervention; therefore you cannot directly  compare the various approaches with respect to outcomes as each have unique indications and differ in expected outcome.

b. Patient-centered outcomes such as function, quality of life, or pain?

Yes, there is a difference in ability to improve patient centered outcomes; spinal fusion approaches and techniques differ in their indications and expected outcomes when treating degenerative stenosis. Approaches and techniques are typically selected on the basis of the level of the spine to be accessed and the required operative intervention; therefore you cannot directly compare the various approaches with respect to outcomes, as each have unique indications and differ in expected outcome. 

c. Adverse events?

Yes there is a difference in the ability to improve adverse events associated with spinal fusion approaches and techniques in treating degenerative stenosis; however you cannot compare the various approaches with respect to adverse events, as each differ in type of adverse events and rate of adverse events and consequences of adverse events.

9. For adults with low back pain attributed to spondylolisthesis of the lumbar spine, do spinal fusion approaches (e.g., anterior, posterior, combined) and techniques (e.g., instrumentation or graft material) differ in the ability to improve:

a. Perioperative outcomes such as surgery time, blood loss, or length of hospital stay?

Yes, there is a difference in ability to improve perioperative outcomes with differing spinal fusion approaches and techniques in treating spondylolisthesis; spinal fusion approaches and techniques differ in their indications and expected outcomes, approaches and techniques are typically selected on the basis of the level of the spine to be accessed and the required operative intervention. Therefore you cannot directly  compare the various approaches with respect to outcomes, as each have unique indications and differ in expected outcome.

b. Patient-centered outcomes such as function, quality of life, or pain?

Yes, there is a difference in ability to improve patient centered outcomes. Spinal fusion approaches and techniques differ in their indications and expected outcomes when treating spondylolisthesis; approaches and techniques are typically selected on the basis of the level of the spine to be accessed and the required operative intervention, so therefore you cannot directly compare the various approaches with respect to outcomes, as each have unique indications and differ in expected outcome.

c. Adverse events?

Yes, there is a difference in the ability to improve adverse events associated with spinal fusion approaches and techniques in treating spondylolisthesis; however, you cannot compare the various approaches with respect to adverse events, as each differ in type of adverse events and rate of adverse events and consequences of adverse events.

10. Are there patient characteristics (e.g., pain severity, prior treatment) that are associated with better or worse outcomes after spinal fusion?

a. Patient-centered outcomes such as function, quality of life, or pain

Yes, there are patient characteristics associated with better or worse patient centered outcomes. For instance, workers compensation or those involved in lawsuits do not do well; those with osteoporosis, diabetes or other systemic medical issues tend to have a higher complication rate. 

b. Adverse events

Yes, there are patient characteristics associated with better or worse rates of adverse events; those with osteoporosis, diabetes or other systemic medical issues tend to have a higher complication rate. 

Also See:

American Association of Neurological Surgeons and Congress of Neurological Surgeons:
AHRQ Comments on Key Questions on the Topic: Spinal Fusion for Painful Lumbar Degenerative Disc or Joint Disease (PDF)