Patient-specific implants for craniomaxillofacial surgery: A manufacturer's experience.

Additive manufacturing technologies have enabled the development of customised implants for craniomaxillofacial applications using biomaterials such as polymethylmethacrylate (PMMA), porous high-density polyethylene (pHDPE), and titanium mesh. This study aims to report an Australian manufacturer's experience in developing, designing and supplying patient-specific craniomaxillofacial implants over 23 years and summarise feedback received from clinicians. The authors conducted a retrospective review of the manufacturer's implant database of orders placed for custom craniomaxillofacial implants between 1996 and 2019. The variables collected included material, country of order, gender, patient age, and reported complications, which included a measure of custom implant "fit" and adverse events. The development of critical checkpoints in the custom manufacturing process that minimise clinical or logistical non-conformities is highlighted and discussed. A total of 4120 patient-specific implants were supplied, of which 2689 were manufactured from PMMA, 885 from titanium mesh, and 546 from pHDPE. The majority of the implants were used in Australia (2260), United Kingdom (412), Germany (377), and New Zealand (338). PMMA was the preferred material for cranial implants whereas pHDPE was preferred for maxillofacial applications. Age or gender did not influence the material choice. Implant "fit" and adverse outcomes were used as a metric of implant performance. Between 2007 and 2019 there were 37 infections (0.98%) and 164 non-conformities recorded of which 75 (1.8%) were related to implant 'fit'. Our experience demonstrates a safe, reliable, and clinically streamlined manufacturing process which supports surgeons that require bespoke craniomaxillofacial solutions for reconstruction surgery.

Patient-specific processes for occipitocervical fixation using biomodelling and additive manufacturing.

This report describes a novel method for occipitocervical fixation using a patient-specific, 3D-printed implant and tools. A 79-year-old female presented with progressive neck pain due to a pathologic fracture of C1. DICOM data was used to 3D-print 1:1 scale biomodels of the occipitocervical spine for pre-operative planning, patient education, and intraoperative reference. The surgeon collaborated with engineers to design and 3D-print a titanium patient-specific implant (PSI) and a stereotactic drill guide for occipitocervical screw fixation. The surgical plan specified the occipitocervical "neutral" position, screw sizes, entry points, and trajectories. The PSI was pre-contoured to match the posterior occipitocervical bony spine and reproduce the planned occipitocervical "neutral" position. Stereotactic portholes for screw fixation were integrated into the PSI. The planned "neutral" position was achieved by intraoperatively matching the occipitocervical alignment to the PSI. Screw placement under fluoroscopy was simplified using the stereotactic drill guide. There were no intraoperative or postoperative complications. At 6-month follow up, our patient reported resolution of symptoms and demonstrated satisfactory occipitocervical alignment without evidence of implant dysfunction. Our experience demonstrates that preoperative planning can be combined with biomodelling and 3D-printing to develop patient-specific tools and implants that are viable for occipitocervical fixation surgery.

Measuring the performance of patient-specific solutions for minimally invasive transforaminal lumbar interbody fusion surgery.

Pre-surgical planning using 3D-printed BioModels enables the preparation of a "patient-specific" kit to assist instrumented spinal fusion surgery. This approach has the potential to decrease operating time while also offering logistical benefits and cost savings for healthcare. We report our experience with this method in 129 consecutive patients undergoing minimally invasive transforaminal lumbar interbody fusion (MIS TLIF) over 27 months at a single centre and performed by a single surgeon. Patient imaging and surgical planning software were used to manufacture a 3D-printed patient-specific MIS TLIF kit for each patient consisting of a 1:1 scale spine BioModel, stereotactic K-wire guide, osteotomy guide, and retractors. Pre-selected pedicle screws, rods, and cages were sourced and supplied with the patient-specific kit. Additional implants were available on-shelf to address a size discrepancy between the kit implant and intraoperative measurements. Each BioModel was used pre-operatively for surgical planning, patient consent and education. The BioModel was sterilised for intraoperative reference and navigation purposes. Efficiency measures included operating time (153 ±â€¯44 min), sterile tray usage (14 ±â€¯3), fluoroscopy screening time (57.2 ±â€¯23.7 s), operative waste (19 ±â€¯8 L contaminated, 116 ±â€¯30 L uncontaminated), and median hospital stay (4 days). The pre-selected kit implants exactly matched intraoperative measurements for 597/639 pedicle screws, 249/258 rods, and 46/148 cages. Pedicle screw placement accuracy was 97.8% (625/639) on postoperative CT. Complications included one intraoperative dural tear, no blood products administered, and six reoperations. Our experience demonstrates a viable application of patient-specific 3D-printed solutions and provides a benchmark for studies of efficiency in spinal fusion surgery.

Designing patient-specific solutions using biomodelling and 3D-printing for revision lumbar spine surgery.

PURPOSE: Despite the variety of "off-the-shelf" implants and instrumentation, outcomes following revision lumbosacral surgery are inconstant. Revision fusion surgery presents a unique set of patient-specific challenges that may not be adequately addressed using universal kits. This study aims to describe how patient-specific factors, surgeon requirements, and healthcare efficiencies were integrated to design and manufacture anatomically matched surgical tools and implants to complement a minimally invasive posterior approach for revision lumbar fusion surgery. METHODS: A 72-year-old woman presented with sciatica and a complex L5-S1 pseudoarthrosis 12 months after L2-S1 fixation surgery for symptomatic degenerative scoliosis. Patient computed tomography data were used to develop 1:1 scale biomodels of the bony lumbosacral spine for pre-operative planning, patient education, and intraoperative reference. The surgeon collaborated with engineers and developed a patient-specific 3D-printed titanium lumbosacral fixation implant secured by L2-L5, S2, and iliac screws. Sizes and trajectories for the S2 and iliac screws were simulated using biomodelling to develop a stereotactic 3D-printed drill guide. Self-docking 3D-printed nylon tubular retractors specific to patient tissue depth and bony anatomy at L5-S1 were developed for a minimally invasive transforaminal approach. The pre-selected screws were separately sourced, bundled with the patient-specific devices, and supplied as a kit to the hospital before surgery. RESULTS: At 6-month follow-up, the patient reported resolution of symptoms. No evidence of implant dysfunction was observed on radiography. CONCLUSION: Pre-operative planning combined with biomodelling and 3D printing is a viable process that enables surgical techniques, equipment, and implants to meet patient and surgeon-specific requirements for revision lumbar fusion surgery.

Designing patient-specific 3D printed devices for posterior atlantoaxial transarticular fixation surgery.

Atlantoaxial transarticular screw fixation is an effective technique for arthrodesis. Surgical accuracy is critical due to the unique anatomy of the atlantoaxial region. Intraoperative aids such as computer-assisted navigation and drilling templates offer trajectory guidance but do not eliminate screw malposition. This study reports the operative and clinical performance of a novel process utilising biomodelling and 3D printing to develop patient specific solutions for posterior transarticular atlantoaxial fixation surgery. Software models and 3D printed 1:1 scale biomodels of the patient's bony atlantoaxial spine were developed from computed tomography data for surgical planning. The surgeon collaborated with a local medical device manufacturer using AnatomicsC3D to design patient specific titanium posterior atlantoaxial fixation implants using transarticular and posterior C1 arch screws. Software enabled the surgeon to specify screw trajectories, screw sizes, and simulate corrected atlantoaxial alignment allowing patient specific stereotactic drill guides and titanium posterior fixation implants to be manufactured using 3D printing. Three female patients with unilateral atlantoaxial osteoarthritis were treated using patient specific implants. Transarticular screws were placed using a percutaneous technique with fluoroscopy and neural monitoring. No screw malposition and no neural or vascular injuries were observed. Average operating and fluoroscopy times were 126.0 ±â€¯4.1 min and 36.7 ±â€¯11.5 s respectively. Blood loss was <50 ml per patient and length of stay was 4-6 days. Clinical and radiographic follow up data indicate satisfactory outcomes in all patients. This study demonstrates a safe, accurate, efficient, and relatively inexpensive process to stabilise the atlantoaxial spine using transarticular screws.

Anterior Lumbar Interbody Fusion as a Salvage Technique for Pseudarthrosis following Posterior Lumbar Fusion Surgery.

Study Design Retrospective analysis of prospectively collected observational data. Objective To assess the safety and efficacy of anterior lumbar interbody fusion (ALIF) as a salvage option for lumbar pseudarthrosis following failed posterior lumbar fusion surgery. Methods From 2009 to 2013, patient outcome data was collected prospectively over 5 years from 327 patients undergoing ALIF performed by a single surgeon (R.J.M.) with 478 levels performed. Among these, there were 20 cases of failed prior posterior fusion that subsequently underwent ALIF. Visual analog score (VAS), Oswestry Disability Index (ODI), and Short Form 12-item health survey (SF-12) were measured pre- and postoperatively. The verification of fusion was determined by utilizing a fine-cut computed tomography scan at 12-month follow-up. Results There was a significant difference between the preoperative (7.25 ± 0.8) and postoperative (3.1 ± 2.1) VAS scores (p < 0.0001). The ODI scale also demonstrated a statistically significant reduction from preoperative (56.3 ± 16.5) and postoperative (30.4 ± 19.3) scores (p < 0.0001). The SF-12 scores were significantly improved after ALIF salvage surgery: Physical Health Composite Score (32.18 ± 5.5 versus 41.07 ± 9.67, p = 0.0003) and Mental Health Composite Score (36.62 ± 12.25 versus 50.89 ± 10.86, p = 0.0001). Overall, 19 patients (95%) achieved successful fusion. Conclusions Overall, our results suggest that the ALIF procedure results not only in radiographic improvements in bony fusion but in significant improvements in the patient's physical and mental experience of pain secondary to lumbar pseudarthrosis. Future multicenter registry studies and randomized controlled trials should be conducted to confirm the long-term benefit of ALIF as a salvage option for failed posterior lumbar fusion.

Anterior lumbar interbody fusion versus transforaminal lumbar interbody fusion--systematic review and meta-analysis.

PURPOSE: To assess the clinical and radiographic outcomes and complications of anterior lumbar interbody fusion (ALIF) versus transforaminal lumbar interbody fusion (TLIF). METHODS: A systematic literature search was conducted from six electronic databases. The relative risk and weighted mean difference (WMD) were used as statistical summary effect sizes. RESULTS: Fusion rates (88.6% vs. 91.9%, P = 0.23) and clinical outcomes were comparable between ALIF and TLIF. ALIF was associated with restoration of disk height (WMD, 2.71 mm, P = 0.01), segmental lordosis (WMD, 2.35, P = 0.03), and whole lumbar lordosis (WMD, 6.33, P = 0.03). ALIF was also associated with longer hospitalization (WMD, 1.8 days, P = 0.01), lower dural injury (0.4% vs. 3.8%, P = 0.05) but higher blood vessel injury (2.6% vs. 0%, P = 0.04). CONCLUSIONS: ALIF and TLIF appear to have similar success and clinical outcomes, with different complication profiles. ALIF may be associated with superior restoration of disk height and lordosis, but requires further validation in future studies.

Minimally invasive percutaneous fixation techniques for metastatic spinal disease.

OBJECTIVE: Surgical treatment of spinal metastasis is generally a palliative procedure. Although minimally invasive surgical (MIS) techniques are supposedly less morbid than open techniques, there is a lack of stratification of MIS techniques based on anticipated longevity. A simple stratification into three percutaneous surgical techniques based on modified Tokuhashi score is here proposed. METHODS: Patients recommended for spinal surgery for metastatic spinal disease between 2009 and 2012 and operated on by the senior author (RJM) were retrospectively reviewed. One of three MIS techniques was offered based on estimated survival using a modified Tokuhashi score. Technique #1 is suitable for patients with predicted short longevity (<6 months). Using a mini-open midline or paramedian decompression and percutaneous screw fixation, the goal here is for rapid mobilization and minimization of hospitalization. Technique #2 is suitable for patients with predicted medium longevity (6-12 months). They are suitable for decompression and/or cement vertebral body replacement and a two levels stabilization. Technique #3 is suitable for patients with predicted long term survival survival (>12 months). In these patients, the primary goal of surgery is a wide local or marginal resection of tumor, decompression of the neurological elements and a robust stabilization construct. They are suitable for an open 360°decompression, vertebral body reconstruction and a multilevel stabilization. RESULTS: The study included eight patients with a mean age of 59 years (range, 36-72 years). Mean modified Tokuhashi score was 10 (range, 7-13) with three patients in the short term, two in the medium term and three in the long term survival category. Mean blood loss was 700 mL (range, 100-1200 mL), mean operating time 280 min (range, 120-360 min) and length of stay in the hospital was on average 13 days (range, 3-30 days). CONCLUSION: The authors present three minimally invasive technique options for the management of spinal metastatic disease corresponding to three clinical prognostic categories. In this small series, MIS techniques resulted in speedy recovery, minimal morbidity and no mortality.

The stability of M(max) and H (max) amplitude over time.

The stability of the maximal muscle response (M(max)) is critical to H reflex methodology. It has previously been reported that the amplitude of M(max) declines over time. If reproducible, this finding would have implications for all experimental studies that normalise the output of the motoneurone pool against the M wave. We investigated the effect of time on changes in M(max) and the maximal H reflex (H(max)) evoked at 4-s intervals over 60 min. To identify an influence of homosynaptic depression, we extended the interstimulus interval to 10 s and the time to 100 min. Two recording montages over soleus were used to ensure that interelectrode distance was not a critical factor. The soleus M(max) and H reflex were evoked by stimulation of the tibial nerve in the popliteal fossa in 7 subjects who sat with the knee flexed to 30° and the ankle plantar flexed by ~30°. We found no change in the pooled data for M(max), H(max), a reflex 50% of maximal, or the current required to produce it. However, one subject had a statistically significant increase in M(max) and a concurrent decrease in H(max) regardless of the interstimulus interval. On average, there was no change in the H(max)/M(max) ratio over time. While both M(max) and H(max) may change in response to many factors, these results suggest that, typically, time is not one of them.