19 Del. Admin. Code § 1342-D-6.0

Current through Register Vol. 27, No. 12, June 1, 2024

Section 1342-D-6.0 - Therapeutic Procedures - Operative

All operative interventions must be based upon positive correlation of clinical findings, clinical course, and diagnostic tests. A comprehensive assimilation of these factors must lead to a specific diagnosis with positive identification of pathologic condition(s). It is important to consider non-physiologic modifiers of pain presentation or non-operative conditions mimicking radiculopathy or instability prior to consideration of elective surgical intervention.

While sufficient time allowances for non-operative treatment are required to determine the natural cause and response to non-operative treatment of low back pain disorders, timely decision making for operative intervention is critical to avoid de-conditioning and increased disability (exclusive of "emergent" or urgent pathology such as cauda equina syndrome or associated rapidly progressive neurologic loss).

In general, if the program of non-operative treatment fails, operative treatment is indicated when:

Improvement of the symptoms has plateaued and the residual symptoms of pain and functional disability are unacceptable at the end of active treatment, or at the end of longer duration of non-operative programs for debilitated patients with complex problems; and/or Frequent recurrences of symptoms cause serious functional limitations even if a non-operative active treatment program provides satisfactory relief of symptoms, and restoration of function on each recurrence. Mere passage of time with poorly guided treatment is not considered an active treatment program.

Surgical evaluation for simple decompression of patients with herniated nucleus pulposus and sciatica should occur within 6 to 12 weeks after injury at the latest, within the above stated contingencies. For patients with true, refractory mechanical low back pain in whom fusion is being considered, it is recommended that a surgical evaluation or interventions occur within 4 months following injury.

Spinal decompression surgeries and fusion have re-operation rates of approximately 10% or more over the following five years. Re-operation is indicated only when the outcome following the re-operation is expected to be better, within a reasonable degree of certainty, than the outcome of other non-invasive or less invasive treatment procedures. "Outcomes" refer to the patient's ability to improve functional tolerances such as sitting, standing, walking, strength, endurance, and/or vocational status and pain level. While timely surgical decision-making is critical to avoid de-conditioning and increased disability, a time limited trial of reconditioning may be tried prior to re-operation.

Every post-operative patient should be involved in an active treatment program. The non-surgical rehab guidelines listed above do not apply to post-operative rehabilitation and work conditioning. Interdisciplinary interventions should be strongly considered post-operatively in any patient not making functional progress within expected time frames.

6.1DISCECTOMY AND NERVE ROOT DECOMPRESSION

6.1.1Description: To enter into and partially remove the disc and/or Decompress Nerve Root.

6.1.2Surgical Indications: May include any of the following: Primary radicular symptoms, radiculopathy on exam, correlating imaging study, and failure of non-surgical care.

6.1.3Post-Operative Therapy: A formal physical therapy program should be implemented post-operatively. Active treatment, which patients should have had prior to surgery, will frequently require a repeat of the visits previously ordered. The non-surgical rehab guidelines listed above do not apply to post-operative rehabilitation and work conditioning

6.2PERCUTANEOUS DISCECTOMY

6.2.1Description: An invasive operative procedure to accomplish partial removal of the disc through a needle which allows aspiration of a portion of the disc trocar under imaging control.

6.2.2Surgical Indications: Percutaneous discectomy is indicated only in cases of suspected septic discitis in order to obtain diagnostic tissue. The procedure is not recommended for contained disc herniations or bulges with associated radiculopathy due to lack of evidence to support long-term improvement.

6.3LAMINOTOMY/LAMINECTOMY/FORAMENOTOMY/FACETECTOMY

6.3.1Description: These procedures provide access to produce neural decompression by partial or total removal of various parts of vertebral bone.

6.3.2Surgical Indications: May include all of the following: Primary radicular symptoms, radiculopathy on exam, correlating imaging study, and failure of non-surgical care.

6.3.3Post-Operative Therapy: A formal rehab program should be implemented post-operatively. Active treatment, which patients should have had prior to surgery, will frequently require a repeat of the visits previously ordered. The implementation of a gentle aerobic reconditioning program (e.g., walking) and back education within the first post-operative week is appropriate in uncomplicated post-surgical cases. Some patients may benefit from several occupational therapy visits to improve performance of ADLs. Participation in an active therapy program which includes restoration of ROM, core stabilization, strengthening, and endurance is recommended. The goals of the therapy program should include instruction in a long-term home based exercise program. The non-surgical physical therapy guidelines listed above do not apply to post-operative rehabilitation and work conditioning.

6.4SPINAL FUSION

6.4.1Description: Production of a rigid connection between two or more adjacent vertebrae.

6.4.2Surgical Indications: A timely decision-making process is recommended when considering patients for possible fusion. For chronic low back problems, fusion should not be considered within the first 4 months of symptoms, except for fracture, dislocation, recurrent herniation, or gross instability

Indications for spinal fusion may include:

6.4.2.1 Neural arch defect - Spondylolytic spondylolisthesis, congenital unilateral neural arch hypoplasia.

6.4.2.2 Segmental Instability - Excessive motion, as in degenerative spondylolisthesis, surgically induced segmental instability.

6.4.2.3 Primary Mechanical Back Pain/Functional Spinal Unit Failure - Multiple pain generators objectively involving two or more of the following: (a) internal disc disruption (poor success rate if more than two disc involved), (b) painful motion segment, as in annular tears, (c) disc resorption, (d) facet syndrome, and or (e) ligamentous tear. (f) Degenerative disc disease.

6.4.2.4 Revision surgery for failed previous operation(s) if significant functional gains are anticipated.

6.4.2.5 History of multiple recurrent herniated discs.

6.4.3Pre-operative Surgical Indications: Required pre-operative clinical surgical indications for spinal fusion include all of the following:

6.4.3.1 Planned fusion to exceed two levels requires confirmatory second opinion.

6.4.3.2 For any potential fusion surgery, it is recommended that the injured worker be encouraged to refrain from smoking for at least six weeks prior to surgery and during the period of fusion healing. Because smokers have a higher risk of non-union and higher post-operative costs, it is recommended that insurers cover a smoking cessation program peri-operatively.

6.4.4Post-operative Therapy: A formal rehab program should be implemented post-operatively. Active treatment, which patients should have had prior to surgery, will frequently require a repeat of the visits previously ordered. The implementation of a gentle aerobic reconditioning program (e.g., walking), and back education within the first post-operative week is appropriate in uncomplicated post-surgical cases. Some patients may benefit from several occupational therapy visits to improve performance of ADLs. Participation in an active therapy program which includes core stabilization, strengthening, and endurance is recommended the goals of the therapy program should include instruction in a long-term home-based exercise program. The non-surgical physical therapy guidelines listed above do not apply to post-operative rehabilitation and work conditioning

6.4.5Return-to-Work: Barring complications, patients responding favorably to spinal fusion may be able to return to sedentary-to-light work within 6 to 12 weeks post-operatively, light-to-medium work within 6 to 9 months post-operatively and medium-to-medium/heavy work within 6 to 12 months post-operatively. Patients requiring fusion whose previous occupation involved heavy-to-very-heavy labor should be considered for vocational assessment as soon as reasonable restrictions can be predicted. The practitioner should release the patient with specific physical restrictions and should obtain a clear job description from the employer, if necessary. Once an injured worker is off work greater than 6 months, the functional prognosis with or without fusion becomes guarded for that individual.

6.5SACROILIAC JOINT FUSION

6.5.1Description: Use of bone grafts, sometimes combined with metal devices, to produce a rigid connection between two or more adjacent vertebrae providing symptomatic instability as a part of major pelvic ring disruption.

6.5.2Surgical Indications: Sacroiliac (SI) joint fusion may be indicated for stabilization of a traumatic severe disruption of the pelvic ring. This procedure has limited use in minor trauma and would be considered only on an individual case-by-case basis. In patients with typical mechanical low back pain, this procedure is considered to be investigational. Until the efficacy of this procedure for mechanical low back pain is determined by an independent valid prospective outcome study, this procedure is not recommended for mechanical low back pain.

6.6IMPLANTABLE SPINAL CORD STIMULATORS are reserved for those low back pain patients with pain of greater than 6 months duration who have not responded to the standard non-operative or operative interventions previously discussed within this document. Refer to Division's Chronic Pain Disorder Medical Treatment Guidelines.

6.7INTRADISCAL ELECTROTHERMAL ANNULOPLASTY (IDEA) (more commonly called IDET, or Intradiscal Electrothermal therapy)

6.7.1Description: An outpatient non-operative procedure. A wire is guided into the identified painful disc using fluoroscopy. The wire is then heated at the nuclear annular junction within the disc. Physicians performing this procedure must have been trained in the procedure and should have performed at least 25 prior discograms. Prior authorization is required for IDET.

6.7.2Surgical Indications: Failure of conservative therapy including physical therapy, medication management, or therapeutic injections. Indications may include those with chronic low back pain, disc related back pain, or pain lasting greater than 6 months. There is conflicting evidence regarding its effectiveness. In one of the most recent studies only approximately 40% of patients had greater than 50% relief of pain. Patients should be aware of these percentages. Strict adherence to the indications is recommended

The candidate should meet the following criteria:

6.7.2.1 Age not above 60 or under 18; and

6.7.2.2 Normal neurological exam; and

6.7.2.3 No evidence of nerve root compression on MRI; and

6.7.2.4 Concordant pain reproduced with provocation discography (low pressure); and

6.7.2.5 Functionally limiting low back pain far in excess of leg pain for at least 6 months; and

6.7.2.6 No evidence of inflammatory arthritis, spinal conditions mimicking low back pain, moderate to severe spinal stenosis, spinal instability, disc herniation, or medical or metabolic diseases precluding follow-up rehabilitation; and

6.7.2.7 Disc height greater than 50% of adjacent normal disc; and

6.7.2.8 No previous IDET procedure at the same level.

6.7.3Post-Procedure Therapy: Some cases may require epidural injection after the IDET procedure has been performed. A corset should be used for the first 6 weeks. Sitting upright is limited to 30 to 45 minutes for the first two weeks. A formal physical therapy program should be implemented post-operatively. Some patients may benefit from several occupational therapy visits to improve performance of ADLs. Rehabilitation may take as long as 6 months and include stretching during the first month, floor exercises in the second month, 3 to 5 consecutive months of progressive exercise program, and sport activities in the 5th and 6th months as tolerated. The goals of the therapy program should include instruction in a long-term home-based exercise program. The non-surgical physical therapy guidelines listed above do not apply to post-operative rehabilitation and work conditioning

Return to Work: Barring complications, may be able to return to limited duty after one to two weeks. A corset should be used for the first six weeks. Sitting upright is limited to 30 to 45 minutes for the first two weeks. Zero to 10 pounds lifting limits for first 6 weeks post-procedure. If successful, patients may return to medium work category (20 to 50 pounds per DOT standards) at 4 to 6 months.

6.8LASER DISCECTOMY involves the delivery of laser energy into the center of the nucleus pulposus using a fluoroscopically guided laser fiber under local anesthesia. The energy denatures protein in the nucleus, causing a structural change which is intended to reduce intradiscal pressure. Its effectiveness has not been shown. Laser discectomy is not recommended.

6.9ARTIFICIAL LUMBAR DISC REPLACEMENT

6.9.1Description: involves the insertion of a prosthetic device into an intervertebral space from which a degenerated disc has been removed, sparing only the peripheral annulus. The endplates are positioned under intraoperative fluoroscopic guidance for optimal placement in the sagittal and frontal planes. The prosthetic device is designed to distribute the mechanical load of the vertebrae in a physiologic manner and maintain range of motion.

General selection criteria for lumbar disc replacement includes symptomatic one-level degenerative disc disease. The patient must also meet fusion surgery criteria, and if the patient is not a candidate for fusion, a disc replacement procedure should not be considered. Additionally, the patient should be able to comply with pre-and post-surgery protocol.

The theoretical advantage of total disc arthroplasty is that it preserves range of motion and physiologic loading of the disc. This could be an advantage for adults who are physically active. Studies do not demonstrate a long-term advantage of measured function or pain over comparison groups undergoing fusion. The longevity of this prosthetic device has not yet been determined. Significant technical training and experience is required to perform this procedure successfully. Surgeons must be well-versed in anterior spinal techniques and should have attended appropriate training courses, or have undergone training during a fellowship. Mentoring and proctoring of procedures is highly recommended. Reasonable pre-operative evaluation may include an angiogram to identify great vessel location. The angiogram may be either with contrast or with magnetic resonance imaging. An assistant surgeon with anterior access experience is required.

6.9.2Surgical Indications:

Symptomatic one-level degenerative disc disease established by objective testing (CT or MRI scan followed by positive provocation discogram, if necessary).

Symptoms unrelieved after six months of active non-surgical treatment, including physical medicine and manual therapy interventions.

6.9.3Contraindications:

Significant spinal deformity/scoliosis Facet joint arthrosis Spinal instability Deficient posterior elements Infection Any contraindications to an anterior abdominal approach (including multiple prior abdominal procedures) Previous compression or burst fracture at the surgical level Spinal canal stenosis Spondylolysis Spondylolisthesis greater than 3 mm Osteoporosis or any metabolic bone disease Chronic steroid use or use of other medication known to interfere with bone or soft tissue healing Autoimmune disorder Allergy to device components/materials Morbid obesity (e.g., body/mass index [BMI] of greater than 40, over 100 pounds overweight) Active malignancy

6.9.4Post-operative Therapy: Bracing may be appropriate. A formal therapy program should be implemented post-operatively. Active treatment, which patients may have had prior to surgery, will frequently require a repeat of the visits previously ordered. The implementation of a gentle aerobic reconditioning program (e.g., walking) and back education within the first post-operative week is appropriate in uncomplicated post-surgical cases. Some patients may benefit from several occupational therapy visits to improve performance of ADLs. Participation in an active therapy program which includes restoration of ROM, core stabilization, strengthening, and endurance is recommended to be initiated at the discretion of the surgeon. Lifting and bending are usually limited for several months at least. Sedentary duty may be able to begin within six weeks in uncomplicated cases. The goals of the therapy program should include instruction in a long-term home based exercise program. The non-surgical therapy guidelines listed above do not apply to post-operative rehabilitation and work conditioning

6.10KYPHOPLASTY

6.10.1Description: A surgical procedure for the treatment of symptomatic thoracic or lumbar vertebral compression fractures, most commonly due to osteoporosis or other metabolic bone disease, and occasionally with post-traumatic compression fractures and minor burst fractures that do not significantly compromise the posterior cortex of the vertebral body. Pain relief can be expected in approximately 90% of patients. Vertebral height correction is inconsistent, with approximately 35% to 40% of procedures failing to restore height or kyphotic angle.

6.10.2Operative Treatment: Kyphoplasty involves the percutaneous insertion of a trocar and inflatable balloon or expanding polymer into the vertebral body, which re-expands the body, elevating the endplates and reducing the compression deformity. Polymethylmethacrylate (PMMA) bone cement is injected under low pressure into the cavity created by the balloon inflation. In contrast to vertebroplasty, which introduces PMMA cement under high pressure, the space created by balloon inflation allows a higher viscosity PMMA to be injected under lower pressure, which may reduce the risks associated with extravertebral extravasation of the material. There may be an advantage to performing the procedure within one month of the fracture, since the elevation of the endplates may be more readily achieved than when the procedure is delayed.

6.10.3Surgical Indications: Kyphoplasty is an accepted treatment for the following indications:

Compression fracture vertebral height loss between 20% and 85% Vertebral height restoration.

Kyphoplasty is more likely to increase vertebral height if performed within 30 days of fracture occurrence

6.10.4Contraindications:

The presence of neurologic compromise related to fracture

High-velocity fractures with a significant burst component

Significant posterior vertebral body wall fracture

Severe vertebral collapse (vertebra plana)

Infection, and

Coagulopathy

6.11VERTEBROPLASTY

6.11.1Description: a procedure for the treatment of painful thoracic and lumbar vertebral compression fractures caused by osteoporosis or other metabolic bone disease. Polymethylmethacrylate (PMMA) bone cement is injected with high pressure into the vertebral body via an 11- to 13-gauge needle, with the goal of stabilizing the spine and relieving pain. The procedure does not correct spinal deformity. Pain relief can be expected in approximately 90% of patients. Vertebral height correction is inconsistent, with approximately 35% to 40% of procedures failing to restore height or kyphotic angle.

6.11.2Indications:

Compression fracture of preferably less than 30 days Vertebral height loss between 20% and 85% Intact posterior wall

6.11.3Contraindications:

The presence of neurologic compromise related to the fracture; High velocity fractures with a significant burst component. Posterior vertebral body wall fracture; Severe vertebral collapse (vertebra plana); and Infection; and Coagulopathy

6.12PERCUTANEOUS RADIOFREQUENCY DISC DECOMPRESSION is an investigational procedure which introduces a 17 gauge cannula under local anesthesia and fluoroscopic guidance into the nucleus pulposus of the contained herniated disc, using radiofrequency energy to dissolve and remove disc material. Pressure inside the disc is lowered as a result. There have been no randomized clinical trials of this procedure at this time. Percutaneous radiofrequency disc decompression is not recommended.

6.13NUCLEUS PULPOSUS REPLACEMENT involves the introduction of a prosthetic implant into the intervertebral disc, replacing the nucleus while preserving the annulus fibrosus. It is limited to investigational use in the United States at this time. It is not recommended.

6.14EPIDUROSCOPY AND EPIDURAL LYSIS OF ADHESIONS (Refer to Injections-Therapeutic).

6.15INTRAOPERATIVE MONITORING is a common intraoperative electrodiagnostic technique that may include somatosensory evoked potentials (SSEP), motor evoked potentials (MEP), or pedicle screw monitoring. The monitoring procedure may be used to evaluate spinal cord integrity and screw placement during the operative procedure. The use of intraoperative monitoring can be anticipated to become more common as percutaneous spinal procedures gain greater acceptance.

19 Del. Admin. Code § 1342-D-6.0

13 DE Reg. 1558 (06/01/10)
17 DE Reg. 322 (9/1/2013) (Final)