Background

Flexion/Extension Radiography

Dynamic spinal visualization and vertebral motion analysis are proposed for individuals who are being evaluated for back or neck pain and are being considered for standard flexion/extension radiographs. Flexion/extension radiographs may be performed with a passive external force or by the patient's own movement. Typically, radiographs are taken at the end ranges of flexion and extension and the intervertebral movements (rotation and translation) are measured to assess spinal instability. Flexion/extension radiographs may be used to assess radiographic instability in order to diagnose and determine the most effective treatment (e.g., physical therapy, decompression, or spinal fusion) or to assess the efficacy of spinal fusion.

Dynamic Spinal Visualization

Digital Motion X-Ray

Most spinal visualization technologies use x-rays to create images either on film, video monitor, or computer screen. Digital motion x-ray involves the use of film x-ray or computer-based x-ray "snapshots" taken in sequence as a patient moves. Film x-rays are digitized into a computer for manipulation, while computer-based x-rays are automatically created in a digital format. Using a computer program, the digitized snapshots are then sequenced and played on a video monitor, creating a moving image of the inside of the body. This moving image can then be evaluated by a physician alone or by using computer software that evaluates several aspects of the body's structure, such as intervertebral flexion and extension, to determine the presence or absence of abnormalities.

Videofluoroscopy and Cineradiography

Videofluoroscopy and cineradiography are different names for the same procedure, which uses fluoroscopy to create real-time video images of internal structures of the body. Unlike standard x-rays, which take a single picture at one point in time, fluoroscopy provides motion pictures of the body. The results of these techniques can be displayed on a video monitor as the procedure is being conducted, as well as recorded, to allow computer analysis or evaluation at a later time. Like digital motion x-ray, the results can be evaluated by a physician alone or with the assistance of computer software.

Dynamic Magnetic Resonance Imaging

Dynamic MRI is also being developed to image the cervical spine. This technique uses an MRI-compatible stepless motorized positioning device and a real-time true fast imaging with steady-state precession sequence to provide passive kinematic imaging of the cervical spine. The quality of the images is lower than a typical MRI sequence but is proposed to be adequate to observe changes in the alignment of vertebral bodies, the width of the spinal canal, and the spinal cord. Higher-resolution imaging can be performed at the end positions of flexion and extension.

Vertebral Motion Analysis

Vertebral motion analysis systems like the KineGraph VMA (Vertebral Motion Analyzer) provide assisted bending with fluoroscopic imaging and computerized analysis. The device uses facial recognition software to track vertebral bodies across the images. Proposed benefits of the vertebral motion analysis are a reduction in patient-driven variability in bending and assessment of vertebral movement across the entire series of imaging rather than at the end range of flexion and extension.

Regulatory Status

In 2012, the KineGraph VMA™ (Vertebral Motion Analyzer; Ortho Kinematics) was cleared for marketing by the U.S. Food and Drug Administration through the 510(k) process (k133875). The system includes a Motion Normalizer™ for patient positioning, standard fluoroscopic imaging, and automated image recognition software. Processing of scans by Ortho Kinematics is charged separately. Table 1 lists the spinal visualization and motion analysis devices currently cleared by the U.S. Food and Drug Administration. Food and Drug Administration product code: LLZ.

Table 1. Spinal Visualization and Motion Analysis Devices Cleared by the U.S. Food and Drug Administration

Device	Manufacturer	Date Cleared	510(k) No.	Indication
Bone VCAR (BVCAR)	GE Medical Systems SCS	4/8/2019	K183204	For use in spinal visualization and motion analysis for neck and back pain
Visualase Thermal Therapy System	Medtronic Navigation Inc.	3/6/2019	K181859	For use in spinal visualization and motion analysis for neck and back pain
mediCAD 4.0	mediCAD Hectec Gmbh	9/7/2018	K170702	For use in spinal visualization and motion analysis for neck and back pain
VirtuOst Vertebral Fracture Assessment	O.N. Diagnostics LLC.	8/3/2018	K171435	For use in spinal visualization and motion analysis for neck and back pain
SPIN-SWI	SpinTech Inc.	2/23/2018	K173224	For use in spinal visualization and motion analysis for neck and back pain
X-PSI Knee System	Orthosoft Inc. (d/b/a Zimmer CAS)	12/28/2017	K171269	For use in spinal visualization and motion analysis for neck and back pain
Surgical Planning Software Version 1.1	Ortho Kinematics Inc.	11/8/2017	K173247	For use in spinal visualization and motion analysis for neck and back pain
OrthoVision	Ewoo Soft Co. Ltd.	10/26/2017	K173094	For use in spinal visualization and motion analysis for neck and back pain
VMAâ„¢ System version 3.0	Ortho Kinematics Inc.	8/25/2017	K172327	For use in spinal visualization and motion analysis for neck and back pain
OKI Surgical Planning Software	Ortho Kinematics Inc.	8/22/2017	K171617	For use in spinal visualization and motion analysis for neck and back pain
UNiD Spine Analyzer	MEDICREA INTERNATIONAL	5/24/2017	K170172	For use in spinal visualization and motion analysis for neck and back pain
Dynamika	IMAGE ANALYSIS LIMITED	5/17/2017	K161601	For use in spinal visualization and motion analysis for neck and back pain
QuantX	Quantitative Insights Inc.	5/17/2017	K170195	For use in spinal visualization and motion analysis for neck and back pain
Move Forward 3D Motion Simulation Service	BIOMET INC.	3/31/2017	K162559	For use in spinal visualization and motion analysis for neck and back pain
kneeEOS	ONEFIT Medical	10/3/2016	K161828	For use in spinal visualization and motion analysis for neck and back pain
JointPoint	JOINTPOINT INC.	8/3/2016	K160284	For use in spinal visualization and motion analysis for neck and back pain
EndoSize	Therenva SAS	4/12/2016	K160376	For use in spinal visualization and motion analysis for neck and back pain
spineEOS	ONEFIT MEDICAL	4/8/2016	K160407	For use in spinal visualization and motion analysis for neck and back pain
Philips Eleva Workspot with SkyFlow	Philips Medical Systems DMC GmbH	12/22/2015	K153318	For use in spinal visualization and motion analysis for neck and back pain
OrthoVis Web Portal	CUSTOM ORTHOPAEDIC SOLUTIONS INC.	10/2/2015	K151501	For use in spinal visualization and motion analysis for neck and back pain
Arthrex OrthoVis Preoperative Plan	Custom Orthopaedic Solutions Inc.	7/31/2015	K151568	For use in spinal visualization and motion analysis for neck and back pain
Centricity Universal Viewer	GE HEALTHCARE	5/26/2015	K150420	For use in spinal visualization and motion analysis for neck and back pain
SPINEDESIGN Spine Surgery Planning (Software Application)	MEDTRONIC SOFAMOR DANEK USA INC.	5/22/2015	K142648	For use in spinal visualization and motion analysis for neck and back pain

Related Policies

• None

The first step in assessing a medical test is to formulate the clinical context and purpose of the test. The test must be technically reliable, clinically valid, and clinically useful for that purpose. Evidence reviews assess the evidence on whether a test is clinically valid and clinically useful. Technical reliability is outside the scope of these reviews, and credible information on technical reliability is available from other sources.

Dynamic Spinal Visualization

Clinical Context and Test Purpose

The purpose of dynamic spinal visualization is to determine whether the abnormal movement of the spine contributes to neck or back pain. This would inform clinical decision making about the appropriate intervention, either physical therapy or surgery.

The question addressed in this policy is: Does the use of dynamic spinal visualization provide additional information beyond that obtained with conventional imaging technology and does this additional information improve health outcomes?

The following PICOs were used to select literature relevant to the review.

Patients

The relevant population of interest are individuals being evaluated for back or neck pain.

Interventions

The test being considered is dynamic spinal visualization, which is administered in an outpatient setting.

Comparators

The following tests are currently being used to make decisions about managing abnormal movement contributing to back and neck pain: conventional radiography and magnetic resonance imaging (MRI), which are administered in an outpatient setting.

Outcomes

The outcomes of interest are whether dynamic spinal visualization leads to new findings and whether these findings improve health outcomes, including pain and function. Timing of short-term outcomes is after completion of physical therapy or surgery.

Technically Reliable

Assessment of technical reliability focuses on specific tests and operators and requires a review of unpublished and often proprietary information. Review of specific tests, operators, and unpublished data are outside the scope of this policy and alternative sources exist. This policy focuses on the clinical validity and clinical utility.

Clinically Valid

A test must detect the presence or absence of a condition, the risk of developing a condition in the future, or treatment response (beneficial or adverse).

As of the most recent literature update, the evidence on dynamic spinal visualization remains predominantly comparisons of spine kinetics in patients with neck or back pain to healthy controls.

Systematic Reviews

A systematic review by Xu et al (2017) reviewed 13 studies on dynamic supine MRI for patients with cervical spondylotic myelopathy, although it appears that the studies evaluated flexion/extension images rather than continuous motion.^1,

Case-Control Studies

Teyhen et al (2007) compared 20 patients with lower back pain to 20 healthy controls to provide construct validity for a clinical prediction rule that would identify patients likely to benefit from stabilization exercises,^2, while Ahmadi et al (2009) used digital videofluoroscopy to compare 15 patients who had lower back pain with 15 controls to refine criteria for diagnosing lumbar segmental instability.^3,

Clinically Useful

A test is clinically useful if the use of the results informs management decisions that improve the net health outcome of care. The net health outcome can be improved if patients receive correct therapy, or more effective therapy, or avoid unnecessary therapy, or avoid unnecessary testing.

Direct Evidence

Direct evidence of clinical utility is provided by studies that have compared health outcomes for patients managed with and without the test. Because these are intervention studies, the preferred evidence would be from randomized controlled trials (RCTs).

No RCTs were identified that support the clinical utility of dynamic spinal visualization for this population.

The literature evaluating the clinical utility of dynamic spinal visualization techniques, including digital motion x-ray and cineradiography (videofluoroscopy) for the evaluation and assessment of the spine, is limited to a few studies involving small numbers of participants.^4,5,6, No evidence was identified to indicate that clinical use improves health outcomes.

Chain of Evidence

Indirect evidence on clinical utility rests on clinical validity. If the evidence is insufficient to demonstrate test performance, no inferences can be made about clinical utility.

Because the clinical validity of dynamic spinal visualization has not been established, a chain of evidence cannot be constructed.

Section Summary: Dynamic Spinal Visualization

The literature evaluating the clinical utility of dynamic spinal visualization techniques, including digital motion x-ray and cineradiography (videofluoroscopy) and dynamic MRI, for the evaluation and assessment of the spine, is limited to a few studies involving small numbers of participants. The available studies have compared spine kinetics in patients who had neck or back pain with that in healthy controls. No literature was identified on the diagnostic accuracy of dynamic visualization in a relevant patient population. No evidence was identified to indicate that clinical use improves health outcomes such as symptoms or function.

Vertebral Motion Analysis

Clinical Context and Test Purpose

The purpose of VMA is to determine whether the abnormal movement of the spine contributes to neck or back pain. This would inform clinical decision making about the appropriate intervention, either physical therapy or surgery. VMA might also be used to assess the success of fusion.

The question addressed in this policy is: Does the use of VMA provide additional information beyond that obtained with conventional imaging technology and does this additional information improve health outcomes?

The following PICOs were used to select literature relevant to the review.

Patients

The relevant population of interest are individuals who are being evaluated for back or neck pain and are being considered for standard flexion/extension radiographs.

Interventions

The test being considered is VMA, which is administered in an outpatient setting.

Comparators

The following tests are currently being used to make decisions about managing abnormal movement contributing to back and neck pain: conventional radiography and MRI, which are administered in an outpatient setting.

Outcomes

The outcomes of interest are whether VMA leads to new findings and whether these findings improve health outcomes, including pain and function. Timing of short-term outcomes is after completion of physical therapy or surgery.

Technically Reliable

Assessment of technical reliability focuses on specific tests and operators and requires a review of unpublished and often proprietary information. Review of specific tests, operators, and unpublished data are outside the scope of this policy and alternative sources exist. This policy focuses on the clinical validity and clinical utility.

Clinically Valid

A test must detect the presence or absence of a condition, the risk of developing a condition in the future, or treatment response (beneficial or adverse).

Cheng et al (2016) and Yeager et al (2014) reported that VMA decreased variability in the measurement of lumbar spinal movement compared with a digitized manual technique.^7,8, Diagnostic performance of VMA was reported by Davis et al (2015) in a retrospective study of 509 symptomatic patients and 73 asymptomatic participants.^9, The comparator was rotational and translational movement from flexion/extension radiographs. The investigators considered instability in symptomatic patients to be true-positive and instability in asymptomatic participants as false-positive, leading to reported differences in diagnostic accuracy between standard flexion/extension radiographs and VMA. In the absence of a true reference standard, the interpretation of this study is limited.

Clinically Useful

A test is clinically useful if the use of the results informs management decisions that improve the net health outcome of care. The net health outcome can be improved if patients receive correct therapy, or more effective therapy, or avoid unnecessary therapy, or avoid unnecessary testing.

Direct Evidence

Direct evidence of clinical utility is provided by studies that have compared health outcomes for patients managed with and without the test. Because these are intervention studies, the preferred evidence would be from RCTs.

No RCTs were identified that support the clinical utility of VMA in this population.

Chain of Evidence

Indirect evidence on clinical utility rests on clinical validity. If the evidence is insufficient to demonstrate test performance, no inferences can be made about clinical utility.

Because the clinical validity of VMA has not been established for this indication, a chain of evidence cannot be constructed.

Section Summary: VMA

Three studies with overlapping authors have been identified on VMA. These studies have reported that VMA reduces variability in the measurement of rotational and translational spine movement compared with standard flexion/extension radiographs. One study reported an improvement in diagnostic accuracy compared with flexion/extension radiographs, but the interpretation of this study is limited by the lack of a true reference standard.

Summary of Evidence

For individuals who have neck or back pain who receive dynamic spinal visualization, the evidence includes comparative trials. The relevant outcomes are test accuracy, symptoms, and functional outcomes. Techniques include digital motion x-rays, cineradiography/videofluoroscopy, or dynamic magnetic resonance imaging of the spine and neck. The available studies compare spine kinetics in patients who had neck or back pain with that in healthy controls. No literature was identified on the diagnostic accuracy of dynamic visualization in a relevant patient population. No evidence was identified on the effect of this technology on symptoms or functional outcomes. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have back or neck pain who receive VMA, the evidence includes comparisons to standard flexion/extension radiographs. The relevant outcomes are test accuracy, symptoms, and functional outcomes. These studies reported that VMA reduces variability in measurement of rotational and translational spine movement compared with standard flexion/extension radiographs. Whether the reduction in variability improves diagnostic accuracy or health outcomes is uncertain. The single study that reported on diagnostic accuracy lacked a true criterion standard, limiting interpretation of findings. The evidence is insufficient to determine the effects of the technology on health outcomes.

SUPPLEMENTAL INFORMATION

Practice Guidelines and Position Statements

No guidelines or statements were identified.

U.S. Preventive Services Task Force Recommendations

Not applicable.

Ongoing and Unpublished Clinical Trials

A search of ClinicalTrials.gov in July 2019 did not identify any ongoing or unpublished trials that would likely influence this policy.]
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Horizon BCBSNJ Medical Policy Development Process:

This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.

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Index:
Dynamic Spinal Visualization and Vertebral Motion Analysis
Dynamic Spinal Visualization
Spinal Visualization, Dynamic
Cineradiography
Videofluoroscopy
Vertebral Motion Analysis
KineGraph VMA™ (Vertebral Motion Analyzer; Ortho Kinematics)

References:
1. Xu N, Wang S, Yuan H, et al. Does dynamic supine magnetic resonance imaging improve the diagnostic accuracy of cervical spondylotic myelopathy? A review of the current evidence. World Neurosurg. Apr 2017;100:474-479. PMID 28130164.

2. Teyhen DS, Flynn TW, Childs JD, et al. Arthrokinematics in a subgroup of patients likely to benefit from a lumbar stabilization exercise program. Phys Ther. Mar 2007;87(3):313-325. PMID 17311885.

3. Ahmadi A, Maroufi N, Behtash H, et al. Kinematic analysis of dynamic lumbar motion in patients with lumbar segmental instability using digital videofluoroscopy. Eur Spine J. Nov 2009;18(11):1677-1685. PMID 19727854.

4. Hino H, Abumi K, Kanayama M, et al. Dynamic motion analysis of normal and unstable cervical spines using cineradiography. An in vivo study. Spine (Phila Pa 1976). Jan 15 1999;24(2):163-168. PMID 9926388.

5. Takayanagi K, Takahashi K, Yamagata M, et al. Using cineradiography for continuous dynamic-motion analysis of the lumbar spine. Spine (Phila Pa 1976). Sep 1 2001;26(17):1858-1865. PMID 11568694.

6. Wong KW, Leong JC, Chan MK, et al. The flexion-extension profile of lumbar spine in 100 healthy volunteers. Spine (Phila Pa 1976). Aug 1 2004;29(15):1636-1641. PMID 15284509.

7. Cheng B, Castellvi AE, Davis RJ, et al. Variability in flexion extension radiographs of the lumbar spine: a comparison of uncontrolled and controlled bending. Int J Spine Surg. Jul 2016;10:20. PMID 27441178.

8. Yeager MS, Cook DJ, Cheng BC. Reliability of computer-assisted lumbar intervertebral measurements using a novel vertebral motion analysis system. Spine J. Feb 1 2014;14(2):274-281. PMID 24239805.

9. Davis RJ, Lee DC, Wade C, et al. Measurement performance of a computer assisted vertebral motion analysis system. Int J Spine Surg. Aug 2015;9:36. PMID 26273554.

Codes:
(The list of codes is not intended to be all-inclusive and is included below for informational purposes only. Inclusion or exclusion of a procedure, diagnosis, drug or device code(s) does not constitute or imply authorization, certification, approval, offer of coverage or guarantee of payment.)

CPT*

76120
76125