Tag Archives: functional capacity evaluation

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.

Baseline Testing: Book End Solution – Does It Qualify as Business Necessity?

Congress enacted the Americans with Disabilities Act in 1990 which included the terms “job-related and consistent with business necessity” in Section 703(k) of Title VII as part of a Congressional compromise. The amendment to the act which went into effect in 2008 did not affect the business necessity provision.

Case law regarding business necessity is very limited; however, a recent case in point is Atkins v. Salazar, 2011 U.S. App. LEXIS 25238 (5th Cir., Dec. 12, 2011), in which the Fifth Circuit issued an instructive opinion analyzing the business necessity defense in the context of diabetes.

The Fifth Circuit described the business necessity standard as follows:

For a qualification to be “job-related,” “the employer must demonstrate that the qualification standard is necessary and related to 'the specific skills and physical requirements of the sought-after position.'” Similarly, for a qualification standard to be “consistent with business necessity,” the employer must show that it “substantially promote[s]” the business' needs.

The court further noted, based on an earlier ruling, that it must “take into account the magnitude of possible harm as well as the probability of occurrence … the probability of the occurrence is discounted by the magnitude of its consequences.”

Under the Americans with Disabilities Act, not only must a medical exam be job-related, it must also be consistent with business necessity. This means that the medical exam must relate to the essential functions of the job. The medical exam must test the ability to perform the primary functions of the job. For example, if you are a cashier at a grocery store, the essential functions of your job would be to ring people up and help them bag their items. Any medical exam your employer required would have to be related to how you perform those functions in order to be consistent with business necessity. It is important to note that as long as the medical exam evaluates some function of the job, it should satisfy the elements of business necessity.

Under the Americans with Disabilities Act, an employer may have the ability to make disability-related inquiries or require medical examination. After the applicant is given a conditional job offer, but before starting work, an employer may make disability-related inquiries and conduct medical examinations, regardless of whether they are related to the job, as long as it does so for all entering employees in the same job category (post-offer). After employment has commenced, an employer may make disability-related inquiries and require medical examinations only if they are job-related and consistent with business necessity.

The Americans with Disabilities Act requires that all medical information obtained during such inquiries or testing be treated as confidential medical information. While this provision covers all employees, only disability-related inquiries and medical examinations are subject to the Americans with Disabilities Act's restrictions. A disability-related inquiry is defined as asking questions or testing that is designed to elicit information about a person's disability. Therefore, questions or testing that is not designed to ask or evaluate information about an individual's disability are not prohibited under the ADA.

A medical test as defined under the Americans with Disabilities Act is a procedure or test that seeks information about an individual's physical or mental impairments or health. Factors that determine if it is a medical test include:

  • whether the test is administered by a health care professional;
  • whether the test is interpreted by a health care professional;
  • whether the test is designed to reveal an impairment or physical or mental health;
  • whether the test is invasive;
  • whether the test measures an employee's performance of a task or measures his/her physiological responses to performing the task;
  • whether the test normally is given in a medical setting; and,
  • whether medical equipment is used.

The topic of medical testing, especially functional testing, is a controversial subject. In the fall of 2009 two major case precedents brought to light these very issues — Indergard vs. Georgia Pacific and the class action lawsuit brought against Sears. On September 29, 2009, the U.S. Equal Employment Opportunity Commission (EEOC) announced a record-setting consent decree resolving a class lawsuit against Sears, Roebuck and Co. under the Americans with Disabilities Act for $6.2 million.

These recent rulings bear out that the Functional Capacity Evaluation (FCE) may be a medical exam. Even when classified as medical evaluations, Functional Capacity Evaluations don't physically correlate with true physiological function. The issue becomes whether or not these tests are able to accurately or objectively test for functionality. These rulings illustrate that Functional Capacity Evaluations that contain validity measurements that are subjective observations, do not correlate with effort and are not consistent with affected body parts are not legally defensible.

As we have seen with the Indergad and Sears cases, courts are examining these issues closely and unless there is an objective assessment, the employer or carrier is left virtually unprotected. For ADA compliance, the testing needs to be repeatable, objective, and address functionality.

Under the Americans with Disabilities Act, an employer may not require a current employee to undergo a medical examination unless the examination “is shown to be job-related and consistent with business necessity.” 42 U.S.C. § 12112(d) (4) (A). This section applies to all employees, whether or not they are disabled under the Americans with Disabilities Act. The Indergard decision clearly demonstrates the need for an objective measure of performance that must conform with business necessity.

In addition, recent case law — EEOC vs. Celadon Trucking — illustrates that if an individual does not meet the essential functions of the job, an employer needs to enter into the interactive process for the position for which they were applying or for any other open position for which the candidate is qualified.

Given all the legal mandates for the ADA and EEOC, coupled with state workers' compensation laws and Federal Mandatory reporting issues for work-related injuries, why do post-offer pre-placement tests? A better solution is baseline testing or a book end solution.

The Americans with Disabilities Act regulates testing that has the potential to evaluate a disability. So if a baseline test is non-invasive, captures the essential functions of the job with not only a reliable validity measurement but with an objective assessment of the muskuloskeltal system and is not read at the time of testing, it is not only acceptable under ADA but technically outside the scope. Why? Data is not evaluated at the time of the baseline test so no disability is identified and no medical questions are asked. It can be done at post-offer or with existing employees.

The book end solution is completed when there is a work-related incident, another test is performed under the workers' compensation pending case, and the results are compared. In the work-related case, the medical evaluation post loss test is allowed and not a violation of the Americans with Disabilities Act. Appropriate releases are signed prior to conducting the baseline testing, and the data is kept confidential. If no work-related injury occurs, the baseline data is never interpreted.

In summary, according to the Fifth Circuit ruling in the Atkins case, for a qualification standard to be “consistent with business necessity,” the employer must show that it “substantially promote[s]” the business' needs. The business needs in the case of baseline tests are to provide better and faster treatment for the injured worker and to accept claims that arise out of the course and scope of employment.