Support

Below are the most common questions about DynaWell L-spine. For additional information and technical support, please contact your nearest distributor.

 

FAQ

1. What scanner systems can DynaWell L-Spine be used with?
All known CT and MRI scanners on the market.

2. What size vest is used with the DynaWell L-Spine?
There are four (4) different size vests included, S, M, L, and XL. XS and XXL are available as options.

3. Does the DynaWell L-Spine come with a warranty?
It comes with a 2 year warranty.

4. Why is this important from a clinical perspective?
The main clinical interest is to obtain a clear image of the lumbar spinal canal in the position where the symptoms are almost always most pronounced.

5. What inter-disciplinary professions are involved with DynaWell L-Spine?
The method has been developed with an inter-disciplinary approach to neuro-surgeons, orthopedics, radiology and chiropractors.

6. What is stress radiology?
Radiology examination performed in different normal positions or in loaded position.

7. What is the invention with DynaWell L-Spine?
A new methodology that allows medical professionals to simulate the upright position of a patient while in a horizontal position. This enhances diagnostic validity.

8. How does the patient benefit from this new method?
He or she gains a more accurate diagnosis, enabling the physician to get an improved basis for decision of therapy and surgery.

9. What is required to use this method clinically?
All you need is a MRI or CT scanner equipped with DynaWell L-Spine, as well as sufficient know-ledge in the fields of radiology, orthopedics, the device, and the methodology.

10. What are the clinical findings that are relevant for the use of DynaWell L-Spine?
Objective signs of sciatica - with or without rhizopathy. Neurogenic claudication and thus a suspected stenosis of any kind in the spinal canal.

11. How would you comment on false positive findings?
All radiological findings should be correlated to subjective symptoms and objective signs to make a diagnostic decision. False positive findings could thus be excluded. Further, this means that no diagnostic specificity (proportion of negative test results in a healthy population) is given for this methodology, because it is not meant to be used with asymptomatic, healthy persons.

12. What are the risks involved from the patient’s perspective?
To date, the risks are limited to the fact that the technology is used to simulate ordinary conditions of a patient standing upright. The side effect observed - when applied within the recommended areas of usage - was short-term, reversible back and leg pain. When used outside approved areas of clinical experience a potential risk is back pain and possible damage to the spine.

13. What percentage of patients may benefit from this type of diagnosis?
This depends on the clinical diagnosis, but in patients with clinical signs of neurogenic claudication, approximately 65% may benefit from such an examination.

14. What are the inclusion and exclusion criteria for examinations with DynaWell L-Spine?
The usage of the technology will always be based on documented clinical experience. Today, this includes suspected sciatica, neurogenic claudication, and spinal stenosis. The exclusion criteria are cerebral or vertebral trauma, tumors, known or suspected osteoporosis, severe cardiopulmonary disease, patients with a history of drug abuse, language barriers that prevent a patient from understanding the procedure, patients who do not meet the standard inclusion criteria for all types of MRI and CT scanning (e.g. pacemakers, metal implants, claustrophobia, etc.), and patients who cannot articulate pain or discomfort.

15. How long time does it take to prepare a patient for this examination?
Less than 5 minutes. A vest is placed around the patient’s chest and shoulders. The patient lies down on the examination table, and becomes attached to the DynaWell L-Spine. It takes about 5 minutes for the human body to adjust anatomically to simulate a vertical position.

16. What is PRP?
PRP is the psoas-relaxed position that is normally used in CT/MRI examinations of the back. The patient is simply lying on his back (supine position) in a relaxed way.

17. What is ACE?
ACE means “axial compression in extension”. This is the compressed position when using DynaWell L-Spine. “Axial compression” means it is a compression along the axis, in this case the spine, in direction between the head and the feet. The “slight extension” means that the posterior concavity of the lumbar spine (lordosis) is kept during compression. This is the closest we can come to simulate standing position.

18. Why measure the area of the dural sac and not the whole spinal canal?
The nerve roots are in the dural sac. Changes in the spinal canal may alterate the dural sac, which in turn influences the nerve roots, and causes the symptoms. The cross-sectional area of the dural sac is most significative in spinal stenosis.

19. Are there any critical values of the DCSA (dural sac cross-sectional area)?
Clinical studies have lead to the determination of:
DCSA < 100 mm2 as relative stenosis
DCSA < 75 mm2 as absolute stenosis
Note that these are guidance values for symptomatic patients only.

20. What difference in DCSA between ACE and PRP is statistically significant?
In a published study, the manual measurement (using computer) of the DCSA showed a measurement error of SD: + 6.5 mm2. The probability that the difference between two measurements of DCSA, if no real difference exists, would exceed 15 mm2 was less than 5%. This means all differences over 15 mm2 can be used as significant, as long as the target area determinations of the DCSA in PRP and ACE are performed by the same person.

21. What does DynaWell L-Spine achieve?
The compression narrows the diameter of the vertebral canal to simulate a normal-load situation, when standing. This, in turn, enables the detection of conditions not seen in a relaxed position. It’s important to mention that this product is not a treatment or cure, but a diagnostic enhancement supplement to CT & MRI technology.

22. What are the economical benefits, compared with standard practices?
From published work to date, it can clearly be concluded that patients benefit from enhanced diagnosis, resulting in an improved basis for decision making by the treating or operating physicians.

23. Where is DynaWell L-Spine manufactured?
It is manufactured in Sweden, since the product was developed together with the Sahlgrenska University’s Hospital in Gothenburg.

24. What reaction do DynaWell anticipate from scanner manufacturers?
All main system manufacturers have shown significant interest in the clinical results. DynaWell is open to potential future co-operation to enhance the quality of the CT and MRI diagnosis. DynaWell believes that weight-baring scans offer new dimensions in diagnosis of spinal disorders.

25. When was DynaWell L-Spine introduced on the US market?
In 1999.

 

 
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How to read your images

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Patient Information Leaflet

 

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