Lerman NonInvasive Halo Cervical Thoracic Orthosis Clinically proven

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, Di. Paolo, 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 all. • 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 52. 5 years Time spent in NIH; 36 – 150 days - Average 79 days Types of fractures: C 1 -C 2 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 l l l 12% ( 2 )non compliance where patient loosened and / or removed NIH. No incidence of Infection No Dysphagia 6% ( 1 ) reported ulcer No scarring l l l 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 Suitabil ity of the noninvasive halo for cervical spine injuries: a retrospective analysis of outcomes. Sawers, Di. Paolo, Rechtine, The Spinal Journal, 2009

Other comparisons Advantages l Lerman NIH can be applied in supine position l Anterior plate of Lerman NIH can be removed quickly if rapid access to thorax required l Floating occipital pad reduces pressure over the occiput l Costs associated with Lerman NIH 40% less the that of Invasive CH Disadvantages l Lerman NIH can be loosened by the patient l Male patients would have difficulty shaving l May not suit obese patients with short chins

l l 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…. .

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