Trulife has been at the forefront in the design and production of medical devices since 1958.
We have recently redesigned the Lerman Non-Invasive Halo which has been designed to address and overcome the complications associated with the use of the traditional Invasive Halo.
Conventional halo devices have been in use since 1959, and for a long time they have been considered to be the best device for the external stabilization required to manage spinal injuries such as internal decapitation.
However, traditional devices are associated with several long-standing issues caused by the pins that are intrinsic to these systems – problems include patient discomfort, scaring at the pin sites, pressure ulcers and an increased risk of infection due to pins coming loose.
Trulife set out to develop a product that has the ability to provide the same level of support and protection but without the issues caused by existing devices. Our goal was to provide a product that would enable the patient to heal with a better quality of life and happily the Lerman NIH achieves just that.Learn more…….
Trulifes Lerman Non-Invasive Halo
Trulife has designed a pin-less orthotic device that provides secure cervical spine stabilization. This is achieved without the use of invasive pins and as a result, it provides a much better experience for the patient.
Studies have shown (more on this later) that a traditional invasive halo system fails to immobilise the unstable cervical spine as much as originally thought.
There are a number of complications associated with Invasive Halo including:
- Pin and Ring loosening – 36% – 60% of patients
- Pin Infection in 20% of cases
- Dysphagia – 4%
- Pressure Ulcers – 11%
- Facial scarring
- Skull and Dural penetration
- Rare but real risk of further neurological deficit during application
The Lerman Non-Invasive Halo manages to provide the same level of support delivered by the conventional halo but removes many of the issues; studies have shown it has far greater patient compliance and tolerance.The Lerman Non-Invasive Halo consists of:
- Padded carbon composite chest plate
- 2 posts for attaching plate to Halo
- Facemask (halo) with Silicone padding
- Posterior occipital support
- Padded criss cross straps posteriorly
Our team has designed the Non-Invasive Halo with color coded buckles that facilitates easy application, making it much less complex to fit than conventional halos. The device has a removable plate included for emergency CPR.Patient Benefits
There are several advantages that Trulifes Lerman Non-Invasive Halo has over traditional spinal orthotic devices. One of the biggest benefits is that it increases the quality of life for a patient during the healing process. Due to the significant reduction in weight, up to almost 50% in many cases, the brace is significantly more comfortable and is less cumbersome to wear. A patient can lie completely horizontally while wearing it.
Providing the right precautions are being taken, it is possible to briefly remove the brace so basic hygiene functions are performed. At this point, a patient can be examined to make sure no skin irritations or infections are apparent.
A key benefit of the Non-Invasive Halo is that patients dont experience any muscle atrophy in their neck and as a result, they can move straight from a brace to a soft collar or in some cases to no collar at all.
A patient may be fitted with the Lerman NIH in the supine position and the anterior plate can be easily removed if emergency access to the thorax is necessary. The floating occipital pad reduces any pressure over the occiput.
The costs associated with the Lerman NIH are up to 40% less than the invasive halo, making it not only more comfortable for the patient but also more affordable.Retrospective Study
A study by Sawers, DiPaola, Rechtine Suitability of the noninvasive halo for cervical spine injuries: a retrospective analysis of outcomes published in The Spinal Journal. 2009; 216 – 220 revealed some notable outcomes.
The study monitored:
- 17 Patients: 8 Female – 9 Male
- All sustained cervical spine injury
- All fitted with NIH by Certified Orthotist at discretion of Consultant
- Average age 52.5 years
- Time spent in NIH; 36 – 150 days – Average 79 days
- Types of fractures: C1-C2 lateral fracture; Rotary subluxation; facet fractures; hangman and odontoid fractures
The outcomes found that all fractures had healed successfully and in alignment. There was no additional loss of neurological function. Almost all patients felt the Lerman was comfortable and secure, and none reverted to the use of an invasive halo.
Exhibitor Data Sheet