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New Data on Whether to Remove Surgical Hardware

Whether to remove hardware implanted in a patient during an earlier surgery raises questions because, while it’s obviously preferable to not leave hardware inside someone, removing the hardware requires cutting through scar tissue and can cause complications.A method we have begun to use and found beneficial after cervical and lumbar surgery is an electrodiagnostic functional assessment (EFA). The EFA combines electromyography (EMG), range of motion (ROM) and a functional capacity evaluation (FCE) to provide additional data about whether hardware removal is necessary.The approach could have broad implications because hardware removal accounts for as much as 33% of all planned orthopedic surgery.Two illustrative cases have been reviewed using the EFA to assess patients after lumbar fusion.The first case involves Mr. P. He is a 34-year-old who sustained a work-related injury on June 7, 2011. He complained of low back pain and right hip pain. He had an MRI that showed degenerative central disk herniation at L5-S1 with retrolisthesis. He failed eight weeks of physical therapy and a lumbar epidural steroid injection. His symptoms improved after this injection for more than three months, but he continued to complain of pain and had not worked for more than a year.

He underwent an L5-S1 posterior lumbar interbody fusion on July 17, 2012. He underwent a reoperation on March 26, 2013, for pseudoarthrosis at L5-S1 and had a fusion revision with bone morphogenic protein and an external bone stimulator.

Despite the operation and revision, he complained of persistent pain, and in September 2013 he continued to be taking Norco. He was still unable to work.

He had a CAT scan of the lumbar spine that showed what appeared to be a solid bony fusion at L5-S1. To try to determine the cause for his pain, he had an EFA test, which revealed appropriate EMG activity while sitting. He had moderate bilateral muscle spasms in the paraspinous muscles, and all other muscle groups evaluated exhibited appropriate EMG activity except for severe weakness in the bilateral quadratus lumborum muscles with compensation in the paraspinous muscles and hamstring muscles.

With these results, it was doubtful that the patient would benefit significantly from hardware removal. He had a hardware block with Marcaine and exhibited only transient benefit.

Nevertheless, because he remained disabled and on narcotics, he underwent a hardware removal and fusion exploration on Dec. 10, 2013. After this operation, he failed to improve, had the same pain, had weakness in his back muscles and still was on narcotic pain medication. He was ultimately released to pain management for weaning of pain medication.

With Mr. P, the EFA suggested he would not benefit from hardware removal, and he did not clinically benefit.

The next case is of Mr. M, a 48-year-old who sustained a work-related injury on Aug. 14, 2011. He underwent workup and had a decompression and fusion with instrumentation from L4 to the sacrum.

Before surgery, he failed physical therapy. After surgery, he had another course of physical therapy that did not benefit him. He continued to complain of bilateral low back pain and increased pain on the left radiating into the leg and foot. In addition, he complained of pins and needles in the same pattern into the left big toe. He was taking Lortab, OxyContin and Flexeril.

Because of his persistent pain, despite the fusion surgery and high doses of narcotics, he was scheduled for an EFA. The EFA revealed minimal bilateral vasoconstriction in the paraspinous muscles from L1 to the sacrum, quadratus lumborum and gluteal muscles that decreased with stretching, indicating a lack of clinical significance. The EFA thus provided objective evidence of noncompliance and lack of effort with all range-of-motion activities.

Taking into consideration the post-operative X-rays, MRI scans and EFA, it was deemed that the patient had reached maximal medical improvement and did not require hardware removal. Rapid weaning of his pain medication was recommended. He was ultimately released to return to work, with no lifting of more than 100 pounds and alternating sitting and standing as required. No further surgery was recommended.

Getting better data on whether to remove hardware is of overwhelming importance because this type of surgery not only requires a second surgical procedure in tissue that is already scarred but poses a risk for nerve injury, delayed fusion failure or progressive spinal deformity. Most series of patients undergoing hardware removal report a complication rate ranging from 3% to 20%. Additionally, hardware removal may not fully correct the problem because retained hardware may be only one of several pain generators in the post-operative spine—pain is the predominant indication for removal of the hardware.

Stabilization and fusion of the lumbar spine may be performed by using various anterior and posterior surgical techniques and a wide range of devices, including pedicle screws, facet screws and different types of vertebral cages and wiring techniques. The instrumentation is designed to stabilize and realign the spine and thereby enhance bone fusion. Post-operative imaging is typically used to determine positioning of the hardware and the progress of the fusion. But there is no reference standard for non-invasive imaging evaluation of spinal fusion. Radiography is the non-invasive procedure most commonly used for the assessment of fusion. Plain films can have limited benefits and frequent inaccuracy. Plain films can document broken or mal-positioned hardware, which is clinically useful. Flexion and extension plain X-rays are recommended for routine assessment of instrumented fusion, but it can be challenging to document translational motion and instability.

An MRI scan is one of the better imaging tools to evaluate post-operative changes in the spine. It is particularly useful for detecting and monitoring infection or post-operative fluid collections and scar formation. It is also excellent at showing soft tissue and neural compression and is beneficial in identifying new pathology above or below the level of fusion. However, MRI is less sensitive in identifying bone healing than plain films or CT scans and, thus, is not the best test to assess fusion of the lumbar spine. The sensitivity of the MRI scan is significantly affected by magnetic-susceptibility artifact, which is often a problem, particularly in the presence of stainless-steel devices or implants. Recent hardware is made of titanium alloys, which produce less severe magnetic artifacts but still present a significant obstacle to visualization of areas near spinal implants.

The CAT scan with sagittal and coronal reconstructions of the lumbar spine is the most sensitive test to determine fusion vs. pseudoarthrosis. It is the best at demonstrating bony union in multiple planes of imaging and is the least affected by metal artifact.

Many spine surgeons would agree that there are some absolute indications for removal of pedicle screw fixation of the lumbar spine. These more absolute indications include:  pseudoarthrosis, persistent infection or abscess after post-surgical debridement, mal-positioned hardware causing neural impingement and migration of hardware or interbody grafts causing neurologic injury. More relative indications for hardware removal include:  broken hardware, prominent hardware, adjacent-level disease, bony erosion around the pedicle screws and metal allergy.

Most studies show that even with hardware removed for absolute or strong relative indications there are favorable outcomes in only 50% to 60% of patients, with high failure rates. These studies are limited because they are retrospective and not evidence-based.

Currently, if well-positioned hardware is painful, there is a method for testing whether removal could be beneficial. The patient is asked to show the doctor the point of tenderness. A local anesthetic is injected at the site. If the patient reports decrease in pain, then it is concluded that the hardware is contributing to the pain. But there are no level 1 evidence-based studies that conclude that there is a high correlation of good outcome with patients who have favorable responses to hardware blocks.

Hardware injections are fraught with subjectivity. Untested findings may subject patients to unnecessary surgery to remove hardware. This is especially problematic in the occupational setting because secondary gain and symptom magnification can play a major role in work-related injuries and their ultimate treatment.

In conclusion: Patients undergoing back fusion are highly complicated cases. Persistent pain after a lumbar fusion can stem from numerous factors, including both physical and psychological ones. In patients who lack objective evidence radiographically for absolute indications for hardware removal, it can be extremely challenging to identify the pain generator.

The EFA could prove instrumental in providing further objective information to identify the cause of dysfunction, pain and disability in patients and could accelerate return to work, while minimizing potential highly complicated and unnecessary surgeries.

Certainly, further studies evaluating outcome are indicated in patients who have persistent pain after lumbar-fusion surgery, using EFA as part of the pre-operative assessment.

The author invites you to join him at the NexGen Workers’ Compensation Summit 2015, to be held Jan. 13 in Carlsbad, CA. The conference, hosted by Emerge Diagnostics, is dedicated to past lessons from, the current status of and the future for workers’ compensation. The conference is an opportunity for companies to network and learn, as well as contribute personal experience to the general knowledge base for workers’ compensation. Six CEU credits are offered. For more information, click here.

What Do New Workers' Compensation Reforms Sweeping the Country Have in Common?

AOECOE – Not Just Another Acronym

California Senate Bill 863 was passed in the fall of 2012 and went into effect on January 1, 2013. Senate Bill 1062 was just signed into law by Governor Mary Fallin of Oklahoma and will take effect January 1, 2014. On April 30, 2013, Tennessee Governor, Bill Haslam, signed into effect Senate Bill 200. House Bill 154 is expected to go into effect in Georgia in July, 2013. What are these bills? The first of many sweeping Workers' Compensation reforms. A common theme in these bills and other pending reforms is to level the playing field for employers and accept only those claims that arise out of the course and scope of employment, AOECOE.

A well-known term of art in the Workers' Compensation arena, AOECOE is not just an acronym. It is transitioning from a term of art to a statement with teeth, as reforms are actually including such wording into bills. The purpose of doing this is to establish whether an employee's alleged injury is work-related and happened in the course and scope of employment, or whether the injury is non-industrial or affected by third parties.

Workers' Compensation is a no fault system and thus benefits the injured worker, as, in order to receive benefits, he or she does not need to prove that the employer was negligent. However, it is the injured party's burden to show that the injury did, in fact, occur while at work, while employed as an employee and while undertaking some activity for the benefit of the employer. The injury itself must have been caused by the accident or employment conditions, and not from some other non-industrial related factors or degenerative factors.

The determination of AOECOE has long been an OSHA policy. OSHA's Injury and Illness Recordkeeping Regulation Section 1904.5: Determination of work-relatedness contained under section (a) basic requirement states in order for an injury or illness to be work-related an event or exposure in the work environment is either caused or contributed to the resulting condition or significantly aggravated a pre-existing injury or illness. Work-relatedness is presumed for injuries and illnesses resulting from events or exposures occurring in the work environment.

California's SB 863 was signed into law by Governor Brown on September 18, 2012, for a January 1, 2013, effective date. While certainly not the first bill to consider AOECOE issues, it is one of the most significant Workers' Compensation reform bills to specify AOECOE language. SB 863 calls for an Independent Medical Review (IMR). While this process may be problematic for an employer, since an IMR can be requested only by an injured worker following a denial, modification, or delay of a treatment request through the utilization review (UR) process, the bill specifically states that this does not apply if the injury is in question for AOECOE reasons.

On May 8, 2013, Oklahoma Governor Fallin signed into law historic Workers' Compensation reform, Senate Bill 1062. The bill defines compensable injury as arising out of the course and scope of employment and does not include: any strain, degeneration damage or harm to disease or condition of the eye or musculoskeletal structure or other body part resulting from the natural result of aging, osteoarthritis, degenerative process or pre-existing, except if a treating physician clearly confirms an identifiable and significant aggravation arising out of AOECOE.

On April 29, 2013, Tennessee Governor Haslam signed a Workers' Compensation reform bill into law, SB 200. It specifies that injuries arise out of and in the course and scope of employment only if proven by a preponderance of evidence that employment contributed more than 50% to causing the injury, AOECOE.

In my experience, the majority of injuries are real, but they are not AOECOE. Injured parties may exaggerate the severity and extent of their injuries or may attempt to hide pre-existing conditions. So how do any employers determine if injuries are AOECOE? The answer is simple. They need to ascertain what the employees' statuses are pre-injury. This is effectively done with baseline testing.

Baseline testing is a bookend solution. To be effective, it should be objective, meet the criteria for evidenced-based medicine, be job related and consistent with medical necessity. It needs to be specific to the metrics being evaluated. A good example of a specific baseline test that is recognized in some jurisdictions by statute is audiometric testing. Hearing tests are routinely done in environments with high noise exposure to determine a baseline that is referenced once a claim is filed. This is commonly referred to as the lock box defense.

Audiometric testing is beneficial for documenting hearing loss but is not designed to address other conditions such as musculoskeletal disorders (MSD). MSDs are the most frequent and costly claims for an employer. In order for a baseline test to be utilized for MSD, it must not only be objective and reproducible, it must contain measurements to ascertain electromyography (EMG), range of motion (ROM) and function.

In addition, baseline testing must be legally defensible. In 1990, Congress enacted the Americans with Disabilities Act that outlines what makes a legally defensible test. To be legally defensible, the testing needs to be job-related and consistent with business necessity i.e. the employer must show that it “substantially promote[s]” the business' needs. It must be repeatable, objective and address functionality. Also, since baseline testing is considered to be a medical exam, it needs to evaluate some functions of the job.

Baseline testing is not a post-offer, pre-placement test, as it can not identify disability because the data is not read and no hiring decisions are made with baseline evaluations. When a work-related injury occurs, a post loss test is conducted, at which time the baseline test is read and compared to the post loss results, hence the bookends.

When compared, the results can determine if an injury exists and if it has arisen out of the course and scope of employment, thus determining an employer's true responsibility. Good baseline testing is non-discriminatory and prevents “false” claims. The sweeping Workers' Compensation reforms allow for a new definition of “false” claim: one that is not AOECOE. A false claim no longer means fraud! A proven example of an effective baseline test is the EFA-STM.

Workers' Compensation statutes are helping employers by allowing them to accept the claims that are only AOECOE. Employers need to see that they comply with legislation, and baseline testing now gives them an objective assessment to do just that.