Purpose Three-dimensional printing (3DP), or additive manufacturing, is an emergent fabrication technology for surgical devices. As a production method, 3DP enables physical realisation of surgical implants from geometrically complex digitalmodels in computer-aided design. Spine surgery has been an innovative adopter of 3DP technology for both patient-specific (PS) and market-available 'Off-The-Shelf' (OTS) implants. The present study assessed clinical evidence for efficacy and safety of both PS and OTS 3DP spinal implants through review of the published literature. The aim was to evaluate the clinical utility of 3DP devices for spinal surgery. Methods A systematic literature review of peer-reviewed papers featured on online medical databases evidencing the application of 3DP (PS and OTS) surgical spine implants was conducted in accordance with PRISMA guidelines. Results Twenty-two peer-reviewed articles and one book-chapter were eligible for systematic review. The published literature was limited to case reports and case series, with a predominant focus on PS designs fabricated from titanium alloys for surgical reconstruction in cases where neoplasia, infection, trauma or degenerative processes of the spine have precipitated significant anatomical complexity. Conclusion PS and 3DP OTS surgical implants have demonstrated considerable utility for the surgical management of complex spine pathology. The reviewed literature indicated that 3DP spinal implants have also been used safely, with positive surgeon-and patient-reported outcomes. However, these conclusions are tentative as the follow-up periods are still relatively short and the number of high-powered studies was limited. Single case and small case series reporting would benefit greatly from more standardised reporting of clinical, radiographic and biomechanical outcomes.
BackgroundLumbar intervertebral disc herniation is a common cause of lower back and leg pain, with surgical intervention (e.g. discectomy to remove the herniated disc) recommended after an appropriate period of conservative management, however the existing or increased breach of the annulus fibrosus persists with the potential of reherniation. Several prosthesis and techniques to reduce re-herniation have been proposed including implantation of an annular closure device (ACD) – Barricaid™ and an annular tissue repair system (AR) – Anulex-Xclose™. The aim of this meta-analysis is to assist surgeons determine a potential approach to reduce incidences of recurrent lumbar disc herniation and assess the current devices regarding their outcomes and complications.MethodsFour electronic full-text databases were systematically searched through September 2017. Data including outcomes of annular closure device/annular repair were extracted. All results were pooled utilising meta-analysis with weighted mean difference and odds ratio as summary statistics.ResultsFour studies met inclusion criteria. Three studies reported the use of Barricaid (ACD) while one study reported the use of Anulex (AR). A total of 24 symptomatic reherniation were reported among 811 discectomies with ACD/AR as compared to 51 out of 645 in the control group (OR: 0.34; 95% CI: 0.20,0.56; I2 = 0%; P < 0.0001). Durotomies were lower among the ACD/AR patients with only 3 reported cases compared to 7 in the control group (OR: 0.54; 95% CI: 0.13, 2.23; I2 = 11%; P = 0.39). Similar outcomes for post-operative Oswestry Disability Index and visual analogue scale were obtained when both groups were compared.ConclusionEarly results showed the use of Barricaid and Anulex devices are beneficial for short term outcomes demonstrating reduction in symptomatic disc reherniation with low post-operative complication rates. Long-term studies are required to further investigate the efficacy of such devices.
Background: The purpose of this systematic review was to evaluate the accuracy and reliability of wearable devices for objective gait measurement of Lumbar Spinal Stenosis (LSS) patients, with a focus on relevant gait metrics. Methods: Systematic searches were conducted of five electronic databases to identify studies that assessed gait metrics by wearable or portable technology. Data was collected according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) statement guidelines. Results: Four articles were identified for inclusion in this review. The objectives, methodology and quality of the studies varied. No single gait metric was investigated in all four studies, making comparison difficult. The most relevant metrics reported included gait cycle, gait velocity, step length and cadence, which were reported in two studies. Two studies explored gait symmetry. Differences between LSS patients and normal healthy subjects are demonstrable using wearable technology. Conclusions: The measurements of gait cycle, cadence, step length, gait velocity, and number of steps with wearable devices can be used in the gait measurement of LSS patients for initial assessment, and objective outcomes following interventions. However, data and analysis are limited, and further studies are necessary to comment on reliability.
We report a case of a 39-year-old male with sciatica who underwent an L5/S1 microdiscectomy with objective physical activity measurements performed preoperatively and continually postoperatively up to 3-month using wireless accelerometer technology linked to the surgical practice; collecting distance travelled, daily step count (DSC) and Gait Velocity (GV). Preoperative, the patient was walking with a GV of 0.97 m/s and a DSC of less than 2,500. After the first month following surgery, the patient had increased mobility, with a GV of 1.58 m/s, and taking an average of over 4,500 steps per day. At day 57 postop, the patient experienced a recurrence of pain with reduction of GV, DSC and walking distance. Magnetic resonance imaging (MRI) was performed and revealed a recurrent disc herniation with further surgery on day 63, with a rapid return of function post 2 nd surgery. The use of wireless accelerometers is practical in obtaining objective physical activity measurements before and after lumbar microdiscectomy, and will assist the surgeon and rehabilitation provider to monitor outcomes, complications and assist in clinical decision making.
Age-related degenerative changes and non-spondylotic pathologies of the cervical spine such as trauma and tumor can lead to compression of neurological structures and result in substantial alteration of the structural anatomy. The end-goal of surgical intervention is to decompress the neural structures which can be achieved via an anterior or a posterior approach, and stabilization of segments to restore stability and alignment. Three-dimensional printing (3DP or Additive Manufacturing) has been applied to the field of medicine, in particular orthopedics and neurosurgery. Coupled with advances of medical imaging such as computed tomography (CT) scans and magnetic resonance imaging (MRI), accurate 3D models of patient anatomy can be produced, and patient-specific implants (PSIs) for complex anatomical reconstruction have all been applied with positive outcomes. 3D printed implants have been applied in particular to the cervical spine predominantly due to the complex and relatively small osteological anatomy and the proximity of important neurovascular structures to the surgical sites. The purpose of this review is to evaluate the current application of 3DP for cervical spinal implants. This includes a review on the available literature on 3D printed PSIs and current available 3D printed "off-the-shelf" (OTS) implants (3D-OTS). Suitable materials for 3DP of spinal implants and the future prospect of cervical implants will be discussed. The review will be concluded with a suggested guide for carrying future studies to evaluate the efficacy and safety of 3DP for cervical spinal implants.
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