Lerman Non-Invasive Halo Cervical Thoracic Orthosis Clinically proven orthosis for cervical stabilization and acute non-invasive cervical spine care
Traditional Invasive Halo Used since 1959,Regarded as ‘the’ standard for external stabilisation for injury to cervical spine. Consists of a 4 pin skull fixation halo and vest Studies have shown that this system fails to immobilise the unstable cervical spine as much as originally thought.
Complications associated with Traditional Invasive Halo • 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 Suitability of the noninvasive halo for cervical spine injuries: a retrospective analysis of outcomes. Sawers, DiPaolo, Rechtine, The Spinal Journal, 2009
Lerman Non-Invasive Halo A pin-less orthotic device that provides secure cervical spine stabilization Designed to address and overcome the complications associated with the use of the traditional Invasive Halo Advantages of Non-Invasive Halo • Provides cervical stabilization with fewer patient complications • Secure and comfortable fit • Minimizes patient positioning to reduce risk of further injury • Improves patient tolerance • Hypoallergenic facemask materials • Can don in supine position with no rolling of patient
Features • Crisscrossed shoulder and waist straps allow for ease of application in supine position, ensuring stability. • Removable anterior plate for emergency cardiopulmonary resuscitation • Large numbers on strap buckles indicate order of application • Padded carbon composite chest plate • Silicone head and chin pads • Height adjustable anterior • MR safe
Patient Benefits •Quality of life for the patient is improved during the healing process. •The brace is significantly more comfortable •A patient can lie completely horizontally whilst wearing it •The brace can be removed briefly to preform basic hygiene functions. Skin can also be examined for irritations or infections. •Patients wearing the Non - Invasive Halo don’t experience any muscle atrophy, as a result, they can move straight from a brace to a soft collar or in some cases to no collar at a ll . •The costs associated with Lerman NIH are up to 40% less than the invasive halo, making it more affordable for the patient.
Proven Clinical Studies
Retrospective study 17 Patients. 8 Female: 9 Male • All sustained cervical spine injury • All fitted with NIH by Certified Orthotist at discretion of Consultant • At least 6 months follow up data available on all • 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
Outcomes All fractures healed successfully and in alignment • No additional loss of neurological function • Most reported the orthosis as feeling comfortable and secure • No-ones course of treatment reverted to use of an Invasive halo • One patient had surgery prior to application • Complications One Occipital Ulcer • 2 Cases of non compliance. 1 due to Dementia Both loosening and removing • orthosis
Invasive Halo Lerman NIH Pin and Ring loosening – 36% - 12% ( 2 )non compliance where 60% of patients patient loosened and / or removed NIH. Pin Infection in 20% of cases No incidence of Infection Dysphagia – 4% No Dysphagia Pressure Ulcers – 11% 6% ( 1 ) reported ulcer Facial scarring No scarring Skull and Dural penetration Suitability of the noninvasive halo for cervical spine injuries: a retrospective analysis of outcomes. Sawers, DiPaolo, Rechtine, The Spinal Journal, 2009
Other comparisons Advantages Lerman NIH can be applied in supine position Anterior plate of Lerman NIH can be removed quickly if rapid access to thorax required Floating occipital pad reduces pressure over the occiput Costs associated with Lerman NIH 40% less the that of Invasive CH Disadvantages Lerman NIH can be loosened by the patient Male patients would have difficulty shaving May not suit obese patients with short chins
Clinical efficacy of the Lerman NIH has been demonstrated. Further studies are warranted Has potential to eliminate complications associated with use of traditional Invasive methods Cost effective – No theatre slot required And…..
…Long hair not a problem!!
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