La. Admin. Code tit. 40 § I-2011

Current through Register Vol. 50, No. 9, September 20, 2024

Section I-2011 - Therapeutic Procedures-Operative

A. All operative interventions should be based on a positive correlation with clinical findings, the natural history of the disease, the clinical course, and diagnostic tests. A comprehensive assimilation of these factors should have led to a specific diagnosis with positive identification of the pathologic condition(s). It is imperative for the clinician to rule out non-physiologic modifiers of pain presentation, or non-operative conditions mimicking radiculopathy or instability (peripheral compressive neuropathy, chronic soft tissue injuries, and psychological conditions), prior to consideration of elective surgical intervention. Early intervention may be required in acute incapacitating pain or in the presence of progressive neurological deficits. Patients who are not candidates for or refuse surgical treatment should be treated with non-operative therapy as indicated.

B. Operative treatment is indicated when the natural history of surgically treated lesions is better than the natural history for non-operatively treated lesions. All patients being considered for surgical intervention should first undergo a comprehensive neuromusculoskeletal examination to identify mechanical pain generators that may respond to non-surgical techniques, or may be refractory to surgical intervention.

1. Referral for surgical evaluation and treatment. Consultation should be made to an appropriate surgical specialist for surgical evaluation and treatment when operative treatment is considered.

a. The decision and recommendation for operative treatment, and the appropriate informed consent should be made by the operating surgeon.

b. Prior to surgical intervention, the patient and treating physician should identify functional operative goals and the likelihood of achieving improved ability to perform activities of daily living or work activities and the patient should agree to comply with the pre- and post-operative treatment plan and home exercise requirements. The patient should understand the length of partial and full disability expected post-operatively

C. In situations requiring the possible need for re-surgery, a second opinion may be necessary. Psychological evaluation is strongly encouraged when surgery is being performed for isolated axial pain to determine if the patient will likely benefit from the treatment.

D. Interdisciplinary interventions should be strongly considered post-operatively in patients not making functional progress within expected time frames (Refer to Interdisciplinary Programs).

E. Return to work activity restrictions should be specific according to the recommendations in Return to Work. Most cervical non-fusion surgical patients can return to a limited level of duty between three to six weeks. Full activity is generally achieved between six weeks to six months, depending on the procedure and healing of the individual.

F. Cervical Operative Procedures and Conditions

1. Acute fractures and dislocations: Decisions regarding the need for surgery in acute traumatic injury will depend on the specific injury type and possibility of long-term neurologic damage. Acute disc herniations may occur in the presence of traumatic injury.

a. Halo Immobilization

i. Description. Intervention that restricts flexion-extension motion. Halo vest will provide significant but not complete rotational control and is the most effective device for treating unstable injuries to the cervical spine.

ii. Complications. May include pin infection, pin loosening, and palsy of the sixth cranial nerve.

iii. Surgical Indications. Cervical fractures requiring the need for nearly complete restriction of rotational control, and to prevent graft dislodgment, spine mal-alignment, or pseudarthrosis. Decision for use of halo is at the discretion of the surgeon based upon the patients' specific injury. Not indicated for unstable skull fractures or if skin overlying pin sites is traumatized.

iv. Operative Treatment. Placement of the pins and apparatus.

v. Post-Operative Therapy. Traction may be required for re-alignment and or fracture reduction (amount to be determined by surgeon), active and/or passive therapy, pin care.

b. Anterior or Posterior Decompression with Fusion

i. Description - to provide relief of pressure on the cervical spinal cord and nerve roots, and alignment and stabilization of the spine. May involve the use of bone grafts, sometimes combined with metal devices, to produce a rigid connection between two or more adjacent vertebrae.

ii. Complications - appropriate medical disclosures should be provided to the patient as deemed necessary by the treating physician.

iii. Surgical Indications - when a significant or progressive neurological deficit exists in the presence of spinal canal compromise. Whether early decompression and reduction of neural structures enhances neurological recovery continues to be debated. Currently, a reasonable approach would be to treat non-progressive neurological deficits on a semi-urgent basis, when the patient's systemic condition is medically stable.

iv. Operative Treatment - both anterior and posterior surgical decompression of the cervical spine are widely accepted. The approach is guided by location of the compressive pathology as well as the presence of other concomitant injuries. Posterior stabilization and fusion alone may be indicated for patients who have been realigned with traction and do not have significant canal compromise. The anterior approach is acceptable if there is disc and/or vertebral body anteriorly compromising the canal. The posterior approach may be indicated in radiculopathy in the absence of myelopathy and with evidence of pseudarthrosis on radiographs, or if the compression pathology is arising posteriorly.

(a). The number of levels involved in the fracture pattern determines the choice between the use of wire techniques versus spinal plates. In injuries treated with an anterior decompression procedure, anterior bone grafting alone does not provide immediate internal fixation and an anterior cervical plate is significantly beneficial. Patients who undergo surgery for significant fracture dislocations of the spine (three level injury) with canal compromise are best managed with anterior cervical decompression, fusion, and plating but in some cases posterior stabilization and fusion are also considered.

(b). Recombinant human bone morphogenetic protein (rhBMP-2) is a member of a family of cytokines capable of inducing bone formation. It is produced from genetically modified cell lines using molecular cloning techniques. Use of rhBMP-2 in the cervical spine may carry a risk of swelling and ectopic bone formation which can encroach on neurovascular structures and on the esophagus. BMP usage in the anterior cervical spine is generally not indicated.

v. Post-Operative Treatment. Cervical bracing may be appropriate (usually 6-12 weeks with fusion). Home programs with instruction in ADLs, sitting, posture, and a daily walking program should be an early part of the rehabilitation process. Referral to a formal rehabilitation program, with emphasis on cervical, scapular, and thoracic strengthening, and restoration of ROM, is appropriate once the fusion is solid and without complication. Active treatment, which patients should have had prior to surgery, will frequently require a repeat of the sessions previously ordered. The goals of the therapy program should include instruction in a long-term home-based exercise program. (Refer to Active Therapy).

2. Disc herniation and other cervical conditions. Operative treatment is indicated only when the natural history of an operatively treatable problem is better than the natural history of the problem without operative treatment. All patients being considered for surgical intervention should undergo a comprehensive neuromuscular examination to identify pain generators that may respond to nonsurgical techniques or may be refractory to surgical intervention. Timely decision making for operative intervention is critical to avoid deconditioning, and increased disability of the cervical spine.

a. General Recommendations. There is some evidence to suggest that recovery from cervical radiculopathy in patients without clinical signs of spinal cord compression at one year is similar with one-level fusion, physical therapy, or rigid cervical collar use. For patients with whiplash injury (Quebec Classification Grade Levels I or II), there is no evidence of any beneficial effect of operative treatment. Refer to (Soft Tissue Injury Evaluation), for Discussion on Quebec Classification Levels.

b. If cervical fusion is being considered, it is recommended that the injured worker refrain from smoking for at least six weeks prior to surgery and during the time of 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.

c. General indications for surgery. operative intervention should be considered and a consultation obtained when improvement of symptoms has plateaued and the residual symptoms of pain and functional disability are unacceptable at the end of six weeks of treatment, or at the end of longer duration of non-operative intervention for debilitated patients with complex problems. Choice of hardware instrumentation is based on anatomy, the patient's pathology, and surgeon's experience and preference.

i. Specific indications include:

(a). for patients with myelopathy immediate surgical evaluation and treatment is indicated;

(b). for patients with cervical radiculopathy:

(i). early intervention may be required for acute incapacitating pain or in the presence of progressive neurological deficits;

(ii). persistent or recurrent arm pain with functional limitations, unresponsive to conservative treatment after six weeks; or

(iii). progressive functional neurological deficit; or

(iv). static neurological deficit associated with significant radicular pain; and

(v). confirmatory imaging studies consistent with clinical findings;

(c). for patients with persistent non-radicular cervical pain: in the absence of a radiculopathy, it is recommended that a decisive commitment to surgical or nonsurgical interventions be made within four to five months following injury. The effectiveness of three-level cervical fusion for non-radicular pain has not been established. In patients with non-radicular cervical pain for whom fusion is being considered, required pre-operative indications include all of the following.

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

[a]. improvement of the symptoms has plateaued, and the residual symptoms of pain and functional disability are unacceptable at the end of 6 to 12 weeks of active treatment, or at the end of longer duration of non-operative programs for debilitated patients with complex problems; and/or

[b]. 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;

[c]. mere passage of time with poorly guided treatment is not considered an active treatment program;

(ii). all pain generators are adequately defined and treated; and

(iii). all physical medicine and manual therapy interventions are completed; and

(iv). x-ray, MRI, or CT/discography demonstrating disc pathology or spinal instability; and

(v). spine pathology limited to two levels; and

(vi). psychosocial evaluation for confounding issues addressed;

(vii). for any potential surgery, it is recommended that the injured worker refrain from smoking for at least six weeks prior to surgery and during the period of 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.

ii. Surgical procedures include:

(a). Cervical Discectomy with or without Fusion

(i). Description. Procedure to relieve pressure on one or more nerve roots or spinal cord. It may be performed with or without the use of a microscope.

(ii). Complications. Appropriate medical disclosures should be provided to the patient as deemed necessary by the treating physician.

(iii). Surgical Indications. Radiculopathy from ruptured disc or spondylosis, spinal instability, or patients with non-radicular neck pain meeting fusion criteria. There is no evidence that discectomy with fusion versus discectomy without fusion has superior long-term results. Discectomy alone is generally considered in patients with pure radicular symptoms from their herniated disc and who have sufficiently large foramen that disc space collapse is unlikely to further compromise the nerve root. Failure rates increase with disease at more than two levels.

(iv). Operative Treatment. Cervical plating may be used to prevent graft dislodgment especially for multi-level disease.

[a]. Recombinant Human Bone Morphogenetic Protein (rhBMP-2) is a member of a family of cytokines capable of inducing bone formation. It is produced from genetically modified cell lines using molecular cloning techniques. Use of rhBMP-2 in the cervical spine may carry a risk of swelling and ectopic bone formation which can encroach on neurovascular structures and on the esophagus. BMP usage in the anterior cervical spine is generally not indicated.

(v). Post-Operative Therapy. Cervical bracing may be appropriate (usually 6 - 12 weeks with fusion). Home programs with instruction in ADLs, sitting, posture, and a daily walking program should be an early part of the rehabilitation process. Referral to a formal rehabilitation program, with emphasis on cervical, scapular, and thoracic strengthening and restoration of ROM is appropriate, once fusion is solid and without complication. Active treatment, which patients should have had prior to surgery, will frequently require a repeat of the sessions previously ordered. The goals of the therapy program should include instruction in a long-term home-based exercise program. (Refer to Active Therapy).

(b). Cervical Corpectomy

(i). Description. Removal of a portion or the entire vertebral body from the front of the spine. May also include removal of the adjacent discs. Usually involves fusion.

(ii). Complications. Appropriate medical disclosures should be provided to the patient as deemed necessary by the treating physician.

(iii). Surgical Indications. Single or two-level spinal stenosis, spondylolisthesis, or severe kyphosis, with cord compression.

(iv). Operative Treatment. Neural decompression, fusion with instrumentation, or halo vest placement to maintain cervical position. Hemicorpectomy may be done when only a portion of the vertebral body needs to be resected. Allografts may be used for single bone graft fusion; however, autografts are generally preferable for multi-level fusions unless a large strut graft is required.

(v). Post-Operative Therapy - dependent upon number of vertebral bodies involved, healing time may be longer than discectomy. Halo vest care is required. Home programs with instruction in ADLs, sitting, posture, and a daily walking program should be an early part of the rehabilitation process. Referral to a formal rehabilitation program with emphasis on cervical, scapular, and thoracic strengthening is appropriate for most patients once the cervical spine is deemed stable and without complication. The goals of the therapy program should include instruction in a long-term home-based exercise program. (Refer to Active Therapy).

(c). Cervical Laminectomy with or without Foraminotomy or Fusion:

(i). Description. Surgical removal of the posterior portion of a vertebrae in order to gain access to the spinal cord or nerve roots with or without stabilization fusion. /instrumentation.

(ii). Complications. May include perineural fibrosis, kyphosis in fractures without fusion or with failed fusion, nerve injury, post surgical instability (with foraminotomies), CSF leak, infection, in-hospital mortality, non-union of fusion, donor site pain (autograft only).

(iii). Surgical Indications. Neural compression.

(iv). Operative Treatment. Laminotomy, partial discectomy, and nerve root decompression.

(v). Post-Operative Therapy. Cervical bracing may be appropriate (usually 6 to 12 weeks with fusion). Home programs with instruction in ADLs, sitting, posture, and a daily walking program should be an early part of the rehabilitation process. Referral to a formal rehabilitation program with emphasis on cervical, scapular, and thoracic strengthening and restoration of ROM is appropriate for most patients once the cervical spine is deemed stable and without complication. The goals of the therapy program should include instruction in a long-term home-based exercise program. (Refer to Active Therapy).

(d). Cervical Laminoplasty

(i). Description. Technique that increases anterior or posterior dimensions of the spinal canal while leaving posterior elements partially intact. It may be performed with or without the use of a microscope.

(ii). Complications. Loss of cervical motion, especially extension.

(iii). Surgical Indications. Multi-level disease: cervical spinal stenosis or spondylitic myelopathy. Not indicated in cervical kyphosis.

(iv). Operative Treatment. Posterior approach, with or without instrumentation.

(v). Post-Operative Therapy. May include 4 to 12 weeks of cervical bracing. Home programs with instruction in ADLs, sitting, posture, and daily walking program should be an early part of the rehabilitation process. Referral to a formal rehabilitation program with emphasis on cervical, scapular, and thoracic strengthening and restoration of ROM is appropriate once the cervical spine is stable and without complication. Active treatment which patients should have had prior to surgery will frequently require a repeat of the sessions previously ordered. The goals of the therapy program should include instruction in a long-term, home-based exercise program. (Refer to Active Therapy).

(e). Percutaneous Discectomy:

(i). Description. 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.

(ii). Complications include, but are not limited to, injuries to the nerve or vessel, infection, and hematoma.

(iii). Surgical 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.

(iv). Operative Treatment: Partial Discectomy

3. Artificial Cervical Disc Replacement. This involves the insertion of an FDA approved prosthetic device into the cervical intervertebral space with the goal of maintaining physiologic motion at the treated cervical segment. The use of artificial discs in motion-preserving technology should be based on the surgeon's skill and training. Artificial disc replacement has been found to be efficacious for both one and two level arthroplasty

4. Percutaneous radiofrequencey disc decompression of the cervical spine is an investigational procedure which introduces a 19 gauge cannula under local anesthesia and fluoroscopic guidance into the nucleus pulposus of a 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. It is not recommended.

5. Epiduroscopy and Epidural Lysis of Adhesions. Refer to Therapeutic Injections.

6. Intraoperative neurophysiologic monitoring (IONM) is a battery of neurophysiologic tests used to assess the functional integrity of the spinal cord, nerve roots, and other peripheral nervous system structures (eg, brachial plexus) during spinal surgery. The underlying principle of IONM is to identify emerging insult to nervous system structures, pathways, and/or related vascular supply and to provide feedback regarding correlative changes in neural function before development of irreversible neural injury. IONM data provide an opportunity for intervention to prevent or minimize postoperative neurologic deficit. Current multimodality monitoring techniques permit intraoperative assessment of the functional integrity of afferent dorsal sensory spinal cord tracts, efferent ventral spinal cord motor tracts, and nerve roots. Combined use of these techniques is useful during complex spinal surgery because these monitoring modalities provide important complementary information to the surgery team. Intraoperative neurophysiologic monitoring should be used during spinal surgery when information regarding spinal cord and nerve root function is desired. The appropriate diagnostic modality for the proposed surgical intervention should be utilized at the discretion of the surgeon.

7. Non invasive electrical bone growth stimulators may be considered:

a. as an adjunct to becomespinal fusion surgery for those at high risk for pseudoarthrosis, including one or more of the following fusion failure risk factors:

i. one or more previous failed spinal fusion(s);

ii. grade ii or worse spondylolisthesis;

iii. fusion to be performed at more than one level;

iv. presence of other risk factors that may contribute to non-healing:

(a). current smoking;

(b). diabetes;

(c). renal disease;

(d). other metabolic diseases where bone healing is likely to be compromised (e.g.: significant osteoporosis);

(e). active alcoholism;

(f). common Morbid obesity BMI 40;

b. as treatment for individuals with failed spinal fusion. Failed spinal fusion is defined as percutaneous spinal procedures gain greater acceptance.a spinal fusion that has not healed at a minimum of 6 months after the original surgery, as evidenced by serial x-rays over a course of 3 months during the latter portion of the 6 month period;

c. no strict criteria for device removal are suggested in the literature. Implanted devices are generally removed only when the patient complains of discomfort, when there is device malfunction, or to allow for future ability to use MRI. Removal of batteries is not recommended unless there is a device malfunction or other complication.

La. Admin. Code tit. 40, § I-2011

Promulgated by the Louisiana Workforce Commission, Office of Workers Compensation Administration, LR 37:1651 (June 2011), amended by the Louisiana Workforce Commission, Office of Workers Compensation, LR 40:1132 (June 2014), Amended LR 49519 (3/1/2023).

AUTHORITY NOTE: Promulgated in accordance with R.S. 23:1203.1.