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result(s) for
"Cervical orthotic device"
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Clinical case study on custom 3D printed collars for dropped head syndrome patients
2025
Background
Dropped Head Syndrome (DHS) is a neurological condition characterized by severe head and neck muscle atrophy, leading to difficulties in maintaining a straight gaze and experiencing severe neck pain during daily activities. Standard off-the-shelf cervical orthotic devices (Neck Collars) often fail to provide adequate support for patients with DHS. This feasibility study aimed to develop and implement a novel feedback-incorporated workflow for creating personalized 3D printed (Powder Bed Fusion) cervical orthotic devices for six DHS patients with varying pathologies.
Case presentation
A tailored workflow was devised and executed to produce bespoke 3D printed cervical orthotic devices for 6 DHS patients. The effectiveness of the collars in supporting patients during activities and reducing neck pain was assessed quantitatively and qualitatively using validated patient support questionnaires, Neck Disability Index, Visual Analog Score for Neck Pain, Global Cervical Angles (GCA), and Vertical Chin Brow Angles (VCBA) before and after intervention. Various clinical and design parameters were analysed to evaluate the collars’ efficacy in supporting patients and reducing neck pain. Patients exhibited an increase in GCA and a decrease in VCBA when using the collars as compared to their previous condition without those. The Visual Analog Score for Neck Pain decreased over the 6-month follow-up period, indicating positive implementation of the bespoke collars.
Conclusion
The personalized design and functionality of the 3D printed collars significantly improved patients’ quality of life, representing a significant advancement in rehabilitative and supportive healthcare interventions. This pilot study lays the groundwork for further large-scale cohort studies.
Journal Article
Cervical orthosis does not improve postoperative pain following posterior cervical fusion: a randomized controlled trial
by
Rasoulinejad, Parham
,
Bailey, Chris
,
Siddiqi, Fawaz
in
Adult
,
Aged
,
Cervical Vertebrae - surgery
2024
Purpose
To determine whether postoperative neck pain in the first 4 weeks following multi-level posterior cervical fusion (PCF) with orthosis is equivalent to multi-level PCF without orthosis.
Methods
Patients were randomly assigned in a 1:1 ratio to postoperative orthosis (CO) for 6 weeks or no orthosis (NO). Randomization was stratified by indication (traumatic vs. degenerative), and preoperative opioid use. A model of longitudinal regression for repeated measures was used. The two-sided 95% confidence interval (CI) was used to test equivalence. If the CI lay between the pre-determined margin of equivalence (−2.0 to + 2.0 pain score) the two groups were considered equivalent. A multiple imputation procedure was used to replace missing data.
Results
Thirty-one patients were enrolled in each group. At baseline, the CO group had more neck pain (5.3 vs. 3.2, p = 0.013). The Four week post-operative neck pain intensity score was 4.6 ± 0.3 for the CO group vs. 4.9 ± 0.3 for the NO group. The 95% confidence interval (−1.2 to 0.6) was within the pre-determined equivalence margin. Neck Disability Index, quality-of-life scores, and arm pain were similar. Eleven patients in the CO group and 12 patients in the NO group had an adverse event. The CO group had reduced range of motion at 6 weeks.
Conclusion
Pain scores over the first 4 weeks after surgery were equivalent for patients undergoing multi-level PCF treated with or without a cervical orthosis. Our findings do not support the routine use of a postoperative cervical orthosis for postoperative pain control.
Clinical Trials Registration Number
NCT04308122, April 22, 2020.
Journal Article
Postoperative Rigid Cervical Collar Leads to Less Axial Neck Pain in the Early Stage After Open-Door Laminoplasty—A Single-Blinded Randomized Controlled Trial
2019
BACKGROUND:Cervical collars are used after laminoplasty to protect the hinge opening, reduce risks of hinge fractures, and avoid spring-back phenomena. However, their use may lead to reduced range of motion and worse neck pain.
OBJECTIVE:To investigate the clinical, radiological, and functional outcomes of patients undergoing single-door laminoplasty with or without collar immobilization.
METHODS:This was a prospective, parallel, single-blinded randomized controlled trial. Patients underwent standardized single-door laminoplasty with mini-plates for cervical myelopathy and were randomly allocated into 2 groups based on the use of collar postoperatively. Clinical assessments included cervical range of motion, axial neck pain (VAS [visual analogue scale]), and objective scores (short-form 36-item, neck disability index, and modified Japanese Orthopaedic Association). All assessments were performed preoperatively and at postoperative 1, 2, 3, and 6 wk, and 3, 6, and 12 mo. Comparative analysis was performed via analysis of variance adjusted by baseline scores, sex, and age as covariates.
RESULTS:A total of 35 patients were recruited and randomized to collar use (n = 16) and without (n = 19). There were no dropouts or complications. There were no differences between groups at baseline. Subjects had comparable objective scores and range of motion at postoperative time-points. Patients without collar use had higher VAS at postoperative 1 wk (5.4 vs 3.5; P = .038) and 2 wk (3.5 vs 1.5; P = .028) but subsequently follow-up revealed no differences between the 2 groups.
CONCLUSION:The use of a rigid collar after laminoplasty leads to less axial neck pain in the first 2 wk after surgery. However, there is no additional benefit with regards to range of motion, quality of life, and complication risk.
Journal Article
Cervical immobilization in trauma patients: soft collars better than rigid collars? A systematic review and meta-analysis
2022
IntroductionRigid cervical spine following trauma immobilization is recommended to reduce neurological disability and provide spinal stability. Soft collars have been proposed as a good alternative because of the complications related to rigid collars. The purpose of this study was to perform a systematic review on soft and rigid collars in the prehospital management of cervical trauma.MethodA systematic review was performed following the PRISMA guidelines. Search terms were (immobilization) AND (collar) AND ((neck) OR (cervical)) to evaluate the range of motion (ROM) and evidence of clinical outcome for soft and rigid collars.ResultsA total of 18 studies met eligibility criteria including 2 clinical studies and 16 articles investigating the range of motion (ROM). Four hundred and ninety-six patients at a mean age of 32.5 years (SD 16.8) were included. Measurements were performed in a seated position in twelve studies. Eight articles reported the ROM without a collar, 7 with a soft collar, and 15 with a rigid collar. There was no significant difference in flexion/extension, bending and rotation following immobilization with soft collars compared to no collar. Rigid collars provided significantly higher stability compared to no collar (p < 0.005) and to soft collars in flexion/extension and rotation movements (p < 0.05). The retrospective clinical studies showed no significant differences in secondary spinal cord injuries for soft collar (0.5%) and for rigid collar (1.1%). One study, comparing immobilization without a collar compared to that with a rigid collar, found a significant difference in neurologic deficiency and supraclavicular nerve lesion.ConclusionAlthough rigid collars provide significant higher stability to no collar and to soft collars in flexion/ extension and rotation movements, clinical studies could not confirm a difference in neurological outcome.Level of EvidenceII, Systematic Review.
Journal Article
The Effect of the Cervical Orthosis on Swallowing Physiology and Cervical Spine Motion During Swallowing
by
Hasegawa, Yasuhiro
,
Ito, Yasuo
,
Matsubayashi, Jun
in
Adult
,
Analysis
,
Cervical Vertebrae - physiology
2016
Cervical orthosis is used to immobilize the neck in various disorders such as trauma and post-operation. However, it is still uncertain how cervical orthosis restricts the degree of movement of the cervical spine during swallowing and how they affect swallowing physiology. The purpose of this study was to evaluate these issues using the Philadelphia
®
Collar. We conducted videofluorography of swallowing in 39 healthy subjects (23 men, 16 women; mean age of 34.3 years) with and without cervical orthosis. To compare the two conditions regarding the cervical spine motion, we determined the angular and positional changes of the occipital bone (C0) and each cervical vertebra (C1–C7) from the oral phase to the pharyngeal phase. Similarly, to compare swallowing physiology, we assessed the start and end times and the durations of soft palate elevation, rapid hyoid anterosuperior movement, epiglottis inversion, closure of the laryngeal vestibule, and pharyngoesophageal segment (PES) opening. Finally, we compared the transit times of contrast agent in the two conditions. The respective extensions of C1, C2, and C3 were 0.31°, 0.07°, and 0.05° (mean) with cervical orthosis, and the respective flexions of C1, C2, and C3 were 0.98°, 1.42°, and 0.85° (mean) without. These results suggested that cervical orthosis restricted the flexion of C1–C3. Analysis of swallowing physiology revealed that the average durations of hyoid anterosuperior elevation, epiglottic inversion, and PES opening were prolonged by 0.09, 0.19, and 0.05 s, respectively. In conclusion, the cervical orthosis restricted the movement of the cervical spine during swallowing and changed swallowing physiology.
Journal Article
Effectiveness and safety of techniques for cervical spine immobilization in mountain rescue
by
Dendorfer, Sebastian
,
Jacob, Matthias
,
Alikhani, Jasmine
in
Care and treatment
,
Cervical spine
,
Cervical Vertebrae - injuries
2026
Background
Cervical spine injuries in alpine sports require immediate immobilization at the site of the accident to avoid possible secondary damage caused by transportation. Using special sensor technology, this study investigated whether a cervical spine orthosis (cervical collar, Stifneck collar (Laerdal Medical GmbH, Puchheim, Germany)) provides greater stability than a vacuum mattress alone.
Methods
Using one male test person, we simulated transporting a patient with a spinal injury in steep alpine terrain. A wireless motion capture system (Xsens Technologies, Movella™ Inc., Henderson, USA) was used to record motion in three-dimensional space within a standardized environment. All tests were performed on a set course by the Bavarian Mountain Rescue Service. The test person lay on a mountain rescue stretcher and was immobilized with a vacuum mattress, either with or without a cervical orthosis. The axes of cervical spine movements were analyzed separately.
Results
There were no significant differences between immobilization with and without a cervical orthosis with regard to lateral flexion (max. 3.7° compared to 3.0°) in the frontal plane and maximum excursion in flexion (max. 1.6° compared to 2.8°) or extension (max. -1.6° compared to -1.7°). There was significantly greater rotation movement around the craniocaudal axis without an orthosis (max. 2.4° compared to 1.3°).
Conclusion
During mountain rescues, the cervical spine can be immobilized without a rigid cervical spine orthosis. Future research should explore the fundamental benefits of cervical spine immobilization, while the findings of this work contribute to the safe care of patients by avoiding the disadvantages associated with rigid cervical orthoses.
Journal Article
Evaluating a novel, low-cost technique for cervical-spine immobilization for application in resource-limited LMICs: a non-inferiority trial
by
Delaney, Peter G
,
Eisner, Zachary J
,
Raghavendran, Krishnan
in
Airway management
,
Biomedical engineering
,
Bone surgery
2022
Study designNon-inferiority trial.ObjectiveLimited cervical spinal (c-spine) immobilization in resource-limited settings of LMICs suggests alternatives are necessary for patients with traumatic injuries. We propose a novel method of c-spine immobilization using folded towels.SettingWashington University in St. Louis.MethodsUsing non-inferiority trial design, thirty healthy patients (median age = 22) were enrolled to test the efficacy of folded towels in comparison with rigid cervical collars, foam neck braces, and no immobilization. We measured cervical range of motion (CROM) in six cardinal directions in seated and supine positions. A weighted composite score (CS) was generated to compare immobilization methods. A preserved fraction of 75% was determined for non-inferiority, corresponding to the difference between the median values for CROM between control (no immobilization) and c-collar states.ResultsC-collars reduce median CROM in six cardinal directions in seated and supine positions by an average of −36.83° seated (−17.75° supine) vs. no immobilization. Folded towels and foam neck braces reduced CROM by −27° seated (−16.75° supine) and −14.25° seated (−9.5° supine), respectively. Compared to a 25% non-inferiority margin (permitting an average 9.21° of cervical movement across six cardinal directions), the CS determined folded towels are non-inferior (CSseated = 0.89, CSsupine = 0.47). Foam neck braces are inferior (CSseated = 2.35, CSsupine = 2.10). CS > 1 surpassed the non-inferiority margin and were deemed inferior.ConclusionsFolded towels are a non-inferior means of immobilizing c-spine in extension and rotation, but not flexion, vs. c-collars. We propose folded towels could be trialed in combination with backboards to deliver affordable and effective prehospital TSCI management in resource-limited settings.
Journal Article
New clinical guidelines on the spinal stabilisation of adult trauma patients – consensus and evidence based
by
Maschmann, Christian
,
Rubin, Monika Afzali
,
Jeppesen, Elisabeth
in
Adult
,
Algorithms
,
Analysis
2019
Traumatic spinal cord injury is a relatively rare injury in Denmark but may result in serious neurological consequences. For decades, prehospital spinal stabilisation with a rigid cervical collar and a hard backboard has been considered to be the most appropriate procedure to prevent secondary spinal cord injuries during patient transportation. However, the procedure has been questioned in recent years, due to the lack of high-quality studies supporting its efficacy. A national interdisciplinary task force was therefore established to provide updated clinical guidelines on prehospital procedures for spinal stabilisation of adult trauma patients in Denmark. The guidelines are based on a systematic review of the literature and grading of the evidence, in addition to a standardised consensus process.
This process yielded five main recommendations:
A strong recommendation against spinal stabilisation of patients with isolated penetrating trauma; a weak recommendation against the prehospital use of a rigid cervical collar and a hard backboard for ABCDE-stable patients; and a weak recommendation for the use of a vacuum mattress for patient transportation. Finally, our group recommends the use of our clinical algorithm to ensure good clinical practice.
Journal Article
Late deep cervical infection after anterior cervical discectomy and fusion: a case report and literature review
2019
Background
Anterior cervical discectomy and fusion (ACDF) is often performed for the treatment of degenerative cervical spine. While this procedure is highly successful, 0.1–1.6% of early and late postoperative infection have been reported although the rate of late infection is very low.
Case presentation
Here, we report a case of 59-year-old male patient who developed deep cervical abscess 30 days after anterior cervical discectomy and titanium cage bone graft fusion (autologous bone) at C3/4 and C4/5. The patient did not have esophageal perforation. The abscess was managed through radical neck dissection approach with repated washing and removal of the titanium implant.
Staphylococcus aureus
was positively cultured from the abscess drainage, for which appropriate antibiotics including cefoxitin, vancomycin, levofloxacin, and cefoperazone were administered postoperatively. In addition, an external Hallo frame was used to support unstable cervical spine. The patient’s deep cervical infection was healed 3 months after debridement and antibiotic administration. His cervial spine was stablized 11 months after the surgery with support of external Hallo Frame.
Conclusions
This case suggested that deep cervical infection should be considered if a patient had history of ACDF even in the absence of esophageal perforation.
Journal Article
The ability of external immobilizers to restrict movement of the cervical spine: a systematic review
by
Hannink, Gerjon
,
Huisman, Joske M. R.
,
Holla, Micha
in
Biomechanical Phenomena
,
Cervical Vertebrae
,
Humans
2016
Purpose
To review the ability of various types of external immobilizers to restrict cervical spine movement.
Methods
With a systematical review of original scientific articles, data on range of motion, type of used external immobilization device and risk of bias were extracted. The described external immobilization devices were grouped and the mean restriction percentage and standard deviation were calculated. Finally, each device was classified based on its ability to restrict movement of the cervical spine, according to five levels of immobilization: poor (MIL <20 %), fair (MIL 20–40 %), moderate (MIL 40–60 %), substantial (MIL 60–80 %), and nearly complete (MIL ≥80 %).
Results
The ability to reduce the range of motion by soft collars was poor in all directions. The ability of cervico-high thoracic devices was moderate for flexion/extension but poor for lateral bending and rotation. The ability of cervico-low thoracic devices to restrict flexion/extension and rotation was moderate, while their ability to restrict lateral bending was poor. All cranio-thoracic devices for non-ambulatory patients restricted cervical spine movement substantial in all directions. The ability of vests with non-invasive skull fixation was substantial in all directions. No studies with healthy adults were identified with respect to cranial traction and halo vests with skull pins and their ability to restrict cervical movement.
Conclusions
Soft collars have a poor ability to reduce mobility of the cervical spine. Cervico-high thoracic devices primarily reduce flexion and extension, but they reduce lateral bending and rotation to a lesser degree. Cervico-low thoracic devices restrict lateral bending to the same extent as cervico-high thoracic devices, but are considerably more effective at restricting flexion, extension, and rotation. Finally, cranio-thoracic devices nearly fully restrict movement of the cervical spine.
Journal Article