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Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_3 | Pages 37 - 37
23 Feb 2023
van der Gaast N Huitema J Brouwers L Edwards M Hermans E Doornberg J Jaarsma R
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Classification systems for tibial plateau fractures suffer from poor interobserver agreement, and their value in preoperative assessment to guide surgical fixation strategies is limited. For tibial plateau fractures four major characteristics are identified: lateral split fragment, posteromedial fragment, anterior tubercle fragment, and central zone of comminution. These fracture characteristics support preoperative assessment of fractures and guide surgical decision-making as each specific component requires a respective fixation strategy. We aimed to evaluate the additional value of 3D-printed models for the identification of tibial plateau fracture characteristics in terms of the interobserver agreement on different fracture characteristics. Preoperative images of 40 patients were randomly selected. Nine trauma surgeons, eight senior and eight junior registrars indicated the presence or absence of four fracture characteristics with and without 3D-printed models. The Fleiss kappa was used to determine interobserver agreement for fracture classification and for interpretation, the Landis and Koch criteria were used. 3D-printed models lead to a categorical improvement in interobserver agreement for three of four fracture characteristics: lateral split (Kconv = 0.445 versus K3Dprint = 0.620; P < 0.001), anterior tubercle fragment (Kconv = 0.288 versus K3Dprint = 0.449; P < 0.001) and zone of comminution (Kconv = 0.535 versus K3Dprint = 0.652; P < 0.001). The overall interobserver agreement improved for three of four fracture characteristics after the addition of 3D printed models. For two fracture characteristics, lateral split and zone of comminution, a substantial interobserver agreement was achieved. Fracture characteristics seem to be a more reliable way to assess tibial plateau fractures and one should consider including these in the preoperative assessment of tibial plateau fractures compared to the commonly used classification systems


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_7 | Pages 101 - 101
1 Jul 2020
Akoury E Ahangar P Luna ASR Nour A Weber M Rosenzweig D
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The spine is one of the most common sites of bony metastasis, with 80% of prostate, lung, and breast cancers metastasizing to the vertebrae resulting in significant morbidity. Current treatment modalities are systemic chemotherapy, such as Doxorubicin (Dox), administered after resection to prevent cancer recurrence, and systemic antiresorptive medication, such as Zolendronate (Zol), to prevent tumor-induced bone destruction. The large systemic doses required to elicit an adequate effect in the spine often leads to significant side-effects by both drugs, limiting their prolonged use and effectiveness. Recently published work by our lab has shown that biocompatible 3D-printed porous polymer scaffolds are an effective way of delivering Dox locally over a sustained period while inhibiting tumor growth in vitro. Our lab has also generated promising results regarding antitumor properties of Zol in vitro. We aim to develop 3D-printed scaffolds to deliver a combination of Zol and Dox that can potentially allow for a synergistic antitumor activity while preventing concurrent bone loss locally at the site of a tumor, avoiding long systemic exposure to these drugs and decreasing side effects in the clinical setting. The PORO Lay polymer filaments are 3D-printed into 5mm diameter disks, washed with deionized water and loaded with Dox or Zol in aqueous buffer over 7 days. Dox or Zol-containing supernatant was collected daily and the drug release was analyzed over time in a fluorescence plate reader. The polymer-drug (Dox or Zol) release was tested in vitro on prostate and lung cancer cell lines and on prostate- or lung-induced bone metastases cells. Alternatively, direct drug treatment was also carried out on the same cells in vitro. Following treatment, all cells were subject to proliferation assay (MTT and alamar blue), viability assay (LIVE/DEAD), migration assay (Boyden chamber) and invasion assay (3D gel matrix). 3D-printed scaffolds loaded with both Dox and Zol will also be tested on cells. We have established an effective dose (EC50) for prostate and lung cancer cell lines and bone metastases cells with direct treatment with Zol or Dox. We have titrated the drug loading of scaffolds to allow for a release amount of Dox at the EC50 dose over 7 days. In ongoing experiments, we are testing the release of Zol. We have shown Dox releasing scaffolds inhibit cancer cell growth in a 2D culture over 7 days using the above cellular assays and testing the scaffolds with Zol is currently being analyzed. 3D-printed porous polymers like the PORO Lay series of products offer a novel and versatile opportunity for delivery of drugs in future clinical settings. They can decrease systemic exposure of drugs while at the same time concentrating the drugs effect at the site of tumors and consequently inhibit tumor proliferation. Their ability to be loaded with multiple drugs can allow for achieving multiple goals while taking advantage of synergistic effects of different drugs. The ability to 3D-print these polymers can allow for production of custom implants that offer better structural support for bone growth


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_5 | Pages 94 - 94
1 Apr 2019
Peterson M Najmabadi Y Robinson R
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INTRODUCTION. Additive manufacturing (3D printing) is used to create porous surfaces that promote bone ingrowth in an effort to improve initial stability and optimize long-term biological fixation. The acetabular cup that was studied is manufactured with titanium alloy powder via electron beam melting. Electron beam melting integrates the porous and solid substrate rather than sintering a porous coating to a solid surface. The 3D-printed acetabular cup's high surface coefficient of friction (up to 1.2), combined with its geometry, creates a predictable press-fit in the acetabulum, improving initial mechanical stability and ultimately leading to reproducible biologic fixation. The objective of this study was to evaluate the early clinical outcomes and implant fixation of this 3D-printed acetabular cup in total hip arthroplasty (THA). METHODS. Four hundred twenty-eight subjects from 8 US and international research sites underwent primary THA with the 3D-printed acetabular cup. All sites received IRB approval prior to conducting the study, and all participants signed the informed consent. Screw usage and number used during surgery were used as a surrogate measurement for initial implant fixation. Clinical performance outcomes included pre- and post-operative Harris Hip Scores (HHS) and Oxford Hip Scores (OHS), patient satisfaction, and revision assessment. 215 patients had a minimum 1-year post-operative follow-up visit. Student t-tests were used to identify significant mean differences (p<0.05). RESULTS. Acetabular screws were used in 206 of 428 cases (48.1%); 85.9% used 1 screw, 12.6% used 2 screws, and 1.5% used 3 screws. For patients with a 1-year post-operative visit, the HHS improved by 49.8 points to 91.9 from 42.1, and the OHS improved by 27.7 points to 44.4 from16.7. Patient satisfaction scores at the 1-year post-operative visit were 9.7±0.7 (n=94). There was no significant difference between genders with regard to BMI, the 1-year post-operative HHS, OHS, or patient satisfaction scores. However, the males were significantly younger (59.8 vs. 62.9 years) and had significantly higher pre-operative HHS (45.7 vs. 37.9) and OHS scores (17.8 vs. 15.3). There were 9 revisions reported. DISCUSSION. For initial implant fixation, compared to a similar, non-3D-printed acetabular cup in the same product line, the 3D-printed cup used significantly fewer screws per case (n=1 for 85.9% cases vs. n=2 for 85.7% of cases) in a fewer percentage of cases (48.1% vs. 70.4%), suggesting greater initial stability and “scratch fit”. The 3D-printed acetabular cup also displayed positive early clinical results as evidenced by the pronounced improvement in clinical outcome scores from the pre-operative visit to the 1-year post-operative visit. These 1-year improvements are better than moderate clinically important improvements reported in the literature (40.1 points for HHS). Patient satisfaction scores were also excellent (9.7/10). There were nine revisions; however, four of these were due to patient falls and one was due to infection. SIGNIFICANCE. The 3D-printed acetabular cup evaluated in this study demonstrated improved implant fixation and positive early clinical outcomes for THA


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_6 | Pages 47 - 47
1 May 2021
Gigi R Gorrtzak Y Golden E Gabay R Rumack N Yaniv M Dadia S Segev E
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Introduction. Patient-specific instruments (PSI) and surgical-guiding templates are gaining popularity as a tool for enhancing surgical accuracy in the correction of oblique bone deformities Three-dimensional virtual surgical planning technology has advanced applications in the correction of deformities of long bones and enables the production of 3D stereolithographic models and PSI based upon a patient's specific deformity. We describe the implementation of this technology in young patients who required a corrective osteotomy for a complex three-plane (oblique plane) lower-limb deformity. Materials and Methods. Radiographs and computerized tomographic (CT) scans (0.5 mm slices) were obtained for each patient. The CT images were imported into post-processing software, and virtual 3D models were created by a segmentation process. Femoral and tibial models and cutting guides with locking points were designed according to the deformity correction plan as designed by the surgeon. The models were used for preoperative planning and as an intraoperative guide. All osteotomies were performed with the PSI secured in the planned position. Results. A total of 17 patients (9 males and 8 females, average age 14.7 years [range 8–24]) comprised the study group. All of the PSI were excellent fits for the planned bone surfaces during surgery. The osteotomies matched the preoperative planning simulation and allowed for easy fixation with pre-chosen plates. No intra- or postoperative complications were encountered. Surgery time was shortened (101 minutes) and intraoperative blood loose was less compared to historical cases. Clinical and radiographic follow-up findings showed highly satisfactory alignment of the treated extremities in all 17 patients. Conclusions. The use of 3D-printed models and patient-specific cutting guides with locking points increases accuracy, shortens procedure time, reduces intraoperative blood loss, and improves the outcome of osteotomies in young patients with complex oblique bone deformities


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_5 | Pages 119 - 119
1 Apr 2019
Cabarcas B Cvetanovich G Orias AE Inoue N Gowd A Liu J Verma N
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Background. Accurate placement of the glenoid component in total shoulder arthroplasty (TSA) is critical to optimize implant longevity. Commercially available patient-specific instrumentation systems can improve implant placement, but may involve considerable expense and production delays of up to six weeks. The purpose of this study was to develop a novel technique for in-house production of 3D-printed, patient-specific glenoid guides, and compare the accuracy of glenoid guidepin placement between the patient-specific guide and a standard guide using a cadaveric model. Methods. Twenty cadaveric shoulder specimens were randomized to receive glenoid guidepin placement via standard TSA guide (Wright Medical, Memphis, TN) or patient-specific guide. Three-dimensional scapular models were reconstructed from CT scans with Mimics 20.0 imaging software (Materialise NV, Leuven, Belgium). A pre-surgical plan was created for all specimens for the central glenoid guidepin of 0º version and inclination angles. Central pin entry and exit points were also calculated. Patient-specific guides were constructed to achieve the planned pin trajectory in Rhino3D software (Robert McNeel & Associates, Seattle, WA). Guides were 3D-printed on a Form2 printer with Formlabs Dental SG Resin (Formlabs, Somerville, MA). Glenoid labrum and cartilage were removed with preservation of other soft tissues in all specimens to mimic intraoperative TSA conditions. A fellowship-trained, board-eligible orthopaedic surgeon placed a 2.5 mm diameter titanium guidepin into each glenoid using the assigned guide for each specimen. After pin placement, repeat CT scans were performed, and a blinded measurer used superimposed 3D scapular reconstructions to calculate deviation from the pre-surgical plan in version and inclination angles, dot product angle, and guide pin entry and exit points. Student's t tests were performed to detect differences between pin placements for the two groups. Results. Cadaver age, sex, and BMI did not differ between groups (p>0.05 for all). Average production cost and time for the patient-specific guides were $29.95 and 4 hours and 40 minutes per guide, respectively. Guidepin version deviation did not differ between the patient-specific and standard guides (1.59º ± 1.60º versus 2.88 º ± 2.11º, respectively, p=0.141). Guidepin inclination deviation was significantly lower in the patient-specific group (1.54º ± 1.58º versus 6.42º ± 5.03º, p=0.009), similarly the dot product angle was lower in the patient-specific compared to standard guide group (2.35º ± 1.66º versus 7.48º ± 4.76º, p=0.005). Glenoid entry site exhibited less deviation for the patient-specific compared to standard guide (0.75mm ± 0.54mm versus 2.05mm ± 1.19mm, p=0.006). Glenoid exit site also was closer to the target for the patient- specific compared to standard group (1.75mm ± 0.99mm versus 4.75mm ± 2.97mm, p=0.010). Conclusion. We present a novel technique for in-house production of 3D-printed, patient-specific glenoid guides for TSA glenoid pin placement. These patient-specific guides improved pin placement accuracy based on 3D-CT measurements compared to standard TSA guides in a cadaveric model. Our patient-specific glenoid guides can be produced on-demand, in-house, inexpensively, and with significantly reduced time compared to commercially available guides. Future studies are required to validate these findings in clinical applications and determine the potential impact on implant longevity


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_15 | Pages 80 - 80
7 Nov 2023
Olivier A Vicatos G
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Custom 3D printed implants can be anatomically designed to assist in complex surgery of the bony pelvis in both orthopaedic oncology and orthopaedic reconstruction surgery.

This series includes patients who had major pelvic bone loss after initially presenting with tumours, fractures or infection after previous total hip arthroplasty. The extent of the bone loss in the pelvis was severe and therefore impossible to be reconstructed by conventional ‘off –the-shelve’ implants. The implant was designed considering the remaining bony structures of the contra-lateral hemi- pelvis, to provide an anatomical, secured support for the reconstructed hip joint. The latter was realised by strategically orientated screws and by porous structures (an integral part of the implant), which stimulates osseointegration. A custom pelvic implant was designed, manufactured and 3D printed. Reconstruction of the pelvis was performed together with a cemented (bipolar bearing) acetabular cup. In some cases, a proximal femoral replacement was also necessary to compensate for bony defects.

All patients had sufficient range of motion (ROM) at the hip with post-operative stability. It has been verified, at six and twelve months postoperatively, that there is a strong hold of the implant due to osseointegration. Additionally, in patients whose posterior acetabular wall was missing, it was discovered that the implant assisted in bone formation and covered the entire posterior surface of the implant.

All patients in this study managed with this novel treatment option, proved to have a stable pelvic reconstruction with restoration of leg lengths, improvement of strength and independent ambulation at short and medium term follow-up.


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_5 | Pages 71 - 71
1 Mar 2017
Owyang D Dadia S Jaere M Auvinet E Brevadt MJ Cobb J
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Introduction. Clear operative oncological margins are the main target in malignant bone tumour resections. Novel techniques like patient specific instruments (PSIs) are becoming more popular in orthopaedic oncology surgeries and arthroplasty in general with studies suggesting improved accuracy and reduced operating time using PSIs compared to conventional techniques and computer assisted surgery. Improved accuracy would allow preservation of more natural bone of patients with smaller tumour margin. Novel low-cost technology improving accuracy of surgical cuts, would facilitate highly delicate surgeries such as Joint Preserving Surgery (JPS) that improves quality of life for patients by preserving the tibial plateau and muscle attachments around the knee whilst removing bone tumours with adequate tumour margins. There are no universal guidelines on PSI designs and there are no studies showing how specific design of PSIs would affect accuracy of the surgical cuts. We hypothesised if an increased depth of the cutting slot guide for sawblades on the PSI would improve accuracy of cuts. Methods. A pilot drybone experiment was set up, testing 3 different designs of a PSI with changing cutting slot depth, simulating removal of a tumour on the proximal tibia (figure 1). A handheld 3D scanner (Artec Spider, Luxembourg) was used to scan tibia drybones and Computer Aided Design (CAD) software was used to simulate osteosarcoma position and plan intentioned cuts (figure 1). PSI were designed accordingly to allow sufficient tumour. The only change for the 3 designs is the cutting slot depth (10mm, 15mm & 20mm). 7 orthopaedic surgeons were recruited to participate and perform JPS on the drybones using each design 2 times. Each fragment was then scanned with the 3D scanner and were then matched onto the reference tibia with customized software to calculate how each cut (inferior-superior-vertical) deviated from plan in millimetres and degrees (figure 3). In order to tackle PSI placement error, a dedicated 3D-printed mould was used. Results. Comparing actual cuts to planned cuts, changing the height of the cutting slot guide on the designed PSI did not deviate accuracy enough to interfere with a tumour resection margin set to maximum 10mm. We have obtained very accurate cuts with the mean deviations(error) for the 3 different designs were: [10mm slot: 0.76±0.52mm, 2.37±1.26°], [15mm slot: 0.43±0.40mm, 1.89±1.04°] and [20mm: 0.74±0.65mm, 2.40±1.78°] respectively, with no significant difference between mean error for each design overall, but the inferior cuts deviation in mm did show to be more precise with 15mm cutting slot (p<0.05) (figure 2). Discussion. Simulating a cut to resect an osteosarcoma, none of the proposed designs introduced error that would interfere with the tumour margin set. Though 15mm showed increased precision on only one parameter, we concluded that 10mm cutting slot would be sufficient for the accuracy needed for this specific surgical intervention. Future work would include comparing PSI slot depth with position of knee implants after arthroplasty, and how optimisation of other design parameters of PSIs can continue to improve accuracy of orthopaedic surgery and allow increase of bone and joint preservation. For figures/tables, please contact authors directly.


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_3 | Pages 54 - 54
23 Feb 2023
Boyle R Stalley P Franks D Guzman M Maher A Scholes C
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We present the indications and outcomes of a series of custom 3D printed titanium acetabular implants used over a 9 year period at our institution (Sydney, Australia), in the setting of revision total hip arthroplasty.

Individualised image-based case planning with additive manufacturing of pelvic components was combined with screw fixation and off-the-shelf femoral components to treat patients presenting with failed hip arthroplasty involving acetabular bone loss. Retrospective chart review was performed on the practices of three contributing surgeons, with an initial search by item number of the Medicare Benefits Scheme linked to a case list maintained by the manufacturer. An analysis of indications, patient demographics and clinical outcome was performed.

The cohort comprised 65.2% female with a median age of 70 years (interquartile range 61–77) and a median follow up of 32.9 months (IQR 13.1 - 49.7). The indications for surgery were infection (12.5%); aseptic loosening (78.1%) and fracture (9.4%), with 65.7% of cases undergoing previous revision hip arthroplasty. A tumour prosthesis was implanted into the proximal femur in 21.9% of cases. Complications were observed in 31.3% of cases, with four cases requiring revision procedures and no deaths reported in this series. Kaplan-Meier analysis of all-cause revision revealed an overall procedure survival of 88.7% at two years (95%confidence interval 69 - 96.2) and 83.8% (95%CI 62 - 93.7) at five years, with pelvic implant-specific survival of 98% (95%CI 86.6 - 99.7) at two and five year follow up.

We conclude that an individualised planning approach for custom 3D printed titanium acetabular implants can provide high overall and implant-specific survival at up to five years follow up in complex cases of failed hip arthroplasty and acetabular bone loss.


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_3 | Pages 85 - 85
23 Feb 2023
Flynn S Lemoine M Boland F O'Brien F O'Byrne J
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Restoration a joint's articular surface following degenerative or traumatic pathology to the osteochondral unit pose a significant challenge. Recent advances have shown the utility of collagen-based scaffolds in the regeneration of osteochondral tissue. To provide these collagen scaffolds with the appropriate superstructure novel techniques in 3D printing have been investigated. This study investigates the use of polyɛ-caprolactone (PCL) collagen scaffolds in a porcine cadaveric model to establish the stability of the biomaterial once implanted.

This study was performed in a porcine cadaveric knee model. 8mm defects were created in the medial femoral trochlea and repaired with a PCL collagen scaffold. Scaffolds were secured by one of three designs; Press Fit (PF), Press Fit with Rings (PFR), Press Fit with Fibrin Glue (PFFG). Mobilisation was simulated by mounting the pig legs on a continuous passive motion (CPM) machine for either 50 or 500 cycles. Biomechanical tensile testing was performed to examine the force required to displace the scaffold.

18 legs were used (6 PF, 6 PFR, 6 PFFG). Fixation remained intact in 17 of the cohort (94%). None of the PF or PFFG scaffolds displaced after CPM cycling. Mean peak forces required to displace the scaffold were highest in the PFFG group (3.173 Newtons, Standard deviation = 1.392N). The lowest peak forces were observed in the PFR group (0.871N, SD = 0.412N), while mean peak force observed in the PF group was 2.436N (SD = 0.768). There was a significant difference between PFFG and PFR (p = 0.005). There was no statistical significance in the relationship between the other groups.

PCL reinforcement of collagen scaffolds provide an innovative solution for improving stiffness of the construct, allowing easier handling for the surgeon. Increasing the stiffness of the scaffold also allows press fit solutions for reliable fixation. Press fit PCL collagen scaffolds with and without fibrin glue provide dependable stability. Tensile testing provides an objective analysis of scaffold fixation. Further investigation of PCL collagen scaffolds in a live animal model to establish quality of osteochondral tissue regeneration are required.


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_3 | Pages 11 - 11
23 Jan 2024
Raj S Magan A Jones SA
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Dual mobility (DM) is an established bearing option in Total Hip Arthroplasty (THA). The traditional mono-block DM designs have limited ability for additional fixation, whereas the modular DM designs allow additional screw fixation but limit internal diameter and have the potential to generate metal debris. We report the early results of a CoCrMo alloy mono-block implant manufactured by additive technology with a highly porous ingrowth surface to enhance primary fixation and osseointegration.

Prospective follow-up of the DuplexTM implant first inserted in March 2016 enrolled into Beyond Compliance (BC). Primary outcome measure was all-cause revision and secondary outcomes dislocation, peri-prosthetic fracture (PPF) and Oxford Hip Score (OHS). Patients were risk stratified and all considered to be high risk for instability. Complications were identified via hospital records, clinical coding linkage using national database and via BC website.

159 implants in 154 patients with a mean age 74.0 years and a maximum F/U of 7 years. Survivorship for all-cause revision 99.4% (95% CI 96.2–99.8). One femoral only revision. Mean gain in OHS 27.4. Dislocation rate 0.6% with a single event. Patients with a cemented Polished taper stem (PTS) had a Type B PPF rate of 2.1% requiring revision/fixation. Compared to conventional THA this cohort was significantly older (74.0 vs 68.3 years), more co-morbidity (ASA 3 46.5% vs 14.4%) and more non-OA indications (32.4% vs 8.5%). Every patient had at least one risk factor for falling and >50% of cohort had 4 or more risk factors using NICE tool.

We believe our results demonstrate that risk stratification successfully aids implant selection to prevent dislocation in high-risk patients. This novel design has provided excellent early results in a challenging cohort where individuals are very different to the “average” THA patient. NJR data on DM has reported an increase in revision for PPF. A “perfect storm” maybe created using DM in high-risk falls risk population. This re-enforces the need to consider all patient and implant factors when deciding bearing selection.


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_3 | Pages 93 - 93
23 Feb 2023
Thai T
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Conventional fracture courses utilise prefabricated sawbones that are not realistic or patient specific. The aim of this study is to determine the feasibility of creating 3D fracture models and utilising them in fracture courses to teach surgical technique.

We selected an AO type 2R3C2 fracture that underwent open reduction internal fixation. De-identified CT scan images were converted to a stereolithography (STL) format. This was then processed using Computer Aided Design (CAD) to create a virtual 3D model. The model was 3D printed using a combination of standard thermoplastic polymer (STP) and a porous filler to create a realistic cortical and cancellous bone. A case-based sawbone workshop was organised for residents, unaccredited registrars, and orthopaedic trainees comparing the fracture model with a prefabricated T-split distal radius fracture. Pre-operative images aided discussion of fixation, and post-operative x-rays allowed comparison between the participants fixation. Participants were provided with identical reduction tools. We created a questionnaire for participants to rate their satisfaction and experience using a Likert scale.

The 3D printed fracture model aided understanding and appreciation of the fracture pattern and key fragments amongst residents and unaccredited trainees. Real case-based models provided a superior learning experience and environment to aid teaching. The generic sawbone provided easier drilling and inserting of screws. Preliminary results show that the cost of 3D printing can be comparable to generic sawbones.

It is feasible to create a fracture model with a real bone feel. Further research and development is required to determine the optimum material to use for a more realistic feel.

The use of 3D printed fracture models is feasible and provides an alternative to generic sawbone fracture models in providing surgical training to residents.


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_3 | Pages 98 - 98
23 Feb 2023
Woodfield T Shum J Tredinnick S Gadomski B Fernandez J McGilvray K Seim H Nelson B Puttlitz C Easley J Hooper G
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Introduction: The mechanobiology and response of bone formation to strain under physiological loading is well established, however investigation into exceedingly soft scaffolds relative to cancellous bone is limited. In this study we designed and 3D printed mechanically-optimised low-stiffness implants, targeting specific strain ranges inducing bone formation and assessed their biological performance in a pre-clinical in vivo load-bearing tibial tuberosity advancement (TTA) model. The TTA model provides an attractive pre-clinical framework to investigate implant osseointegration within an uneven loading environment due to the dominating patellar tendon force.

A knee finite element model from ovine CT data was developed to determine physiological target strains from simulated TTA surgery. We 3D printed low-stiffness Ti wedge osteotomy implants with homogeneous stiffness of 0.8 GPa (Ti1), 0.6 GPa (Ti2) and a locally-optimised design with a 0.3 GPa cortex and soft 0.1 GPa core (Ti3), for implantation in a 12-week ovine tibial advancement osteotomy (9mm). We quantitatively assessed bone fusion, bone area, mineral apposition rate and bone formation rate.

Optimised Ti3 implants exhibited evenly high strains throughout, despite uneven wedge osteotomy loading. We demonstrated that higher strains above 3.75%, led to greater bone formation. Histomorphometry showed uniform bone ingrowthin optimised Ti3 compared to homogeneous designs (Ti1 and Ti2), and greater bone-implant contact. The greatest bone formation scores were seen in Ti3, followed by Ti2 and Ti1.

Results from our study indicate lower stiffness and higher strain ranges than normally achieved in Ti scaffolds stimulate early bone formation. By accounting for loading environments through rational design, implants can be optimised to improve uniform osseointegration. Design and 3D printing of exceedingly soft titanium orthopaedic implants enhance strain induced bone formation and have significant importance in future implant design for knee, hip arthroplasty and treatment of large load-bearing bone defects.


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_3 | Pages 99 - 99
23 Feb 2023
Woodfield T Shum J Linkhorn W Gadomski B Puttlitz C McGilvray K Seim H Nelson B Easley J Hooper G
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Polyetheretherketone (PEEK) interbody fusion cages combined with autologous bone graft is the current clinical gold standard treatment for spinal fusion, however, bone graft harvest increases surgical time, risk of infection and chronic pain. We describe novel low-stiffness 3D Printed titanium interbody cages without autologous bone graft and assessed their biological performance in a pre-clinical in vivo interbody fusion model in comparison to the gold standard, PEEK with graft.

Titanium interbody spacers were 3D Printed with a microporous (Ti1: <1000μm) and macroporous (Ti2: >1000μm) design. Both Ti1 and Ti2 had an identical elastic modulus (stiffness), and were similar to the elastic modulus of PEEK. Interbody fusion was performed on L2-L3 and L4-L5 vertebral levels in 24 skeletally mature sheep using Ti1 or Ti2 spacers, or a PEEK spacer filled with iliac crest autograft, and assessed at 8 and 16 weeks. We quantitatively assessed bone fusion, bone area, mineral apposition rate and bone formation rate. Functional spinal units were biomechanically tested to analyse range of motion, neutral zone, and stiffness. Results: Bone formation in macroporous Ti2 was significantly greater than microporous Ti1 treatments (p=.006). Fusion scores for Ti2 and PEEK demonstrated greater rates of bone formation from 8 to 16 weeks, with bridging rates of 100% for Ti2 at 16 weeks compared to just 88% for PEEK and 50% for Ti1. Biomechanical outcomes significantly improved at 16 versus 8 weeks, with no significant differences between Ti and PEEK with graft.

This study demonstrated that macroporous 3D Printed Ti spacers are able to achieve fixation and arthrodesis with complete bone fusion by 16 weeks without the need for bone graft. These significant data indicate that low-modulus 3D Printed titanium interbody cages have similar performance to autograft-filled PEEK, and could be reliably used in spinal fusion avoiding the complications of bone graft harvesting.


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_8 | Pages 26 - 26
1 Aug 2020
Wong I Ravipati APT
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To determine the effect that preoperative use of 3D printed models has on the outcomes for femoroacetabular impingement (FAI) surgery.

Ninety patients that underwent FAI surgeries by the same surgeon were retrospectively analyzed. Patients were age- and sex-matched for two groups - those who had pre-operative 3D printed hip models (n=45) and those with conventional planning using X-rays and/or CT scan (n=45) were identified. Radiographic parameters on pre- and post-operative radiographs that include the alpha angle (45 Dunn view), center edge angle (CEA) (weight bearing AP pelvis), and head-neck offset ratio (cross-table lateral) were obtained. Clinical outcomes were assessed by analyzing iHOT and HOS scores pre- and post-operatively.

Ninety patients (3D printed group 45, Conventional group 45) with a mean age of 36 years were evaluated. Mean follow-up time was 28 months. For all of the radiological variables (CEA and alpha angle), there was a significant improvement seen for both groups (p=0.001). However, the 3D printed group showed significantly better resection of bone to a normal alpha angle (< 5 5) than did the Conventional group. Additionally, head-neck offset was significantly better in the 3D printed group (p=0.001). Statistically significant improvements were seen in both groups on the HOS and iHOT-33 (p=0.001).

Planning FAI surgery using 3D hip models helps in achieving better resection, especially in CAM-type FAI.


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_6 | Pages 106 - 106
1 Jul 2020
Dion C Lanting B Howard J Teeter M Willing R
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During revision total knee arthroplasty (rTKA), proximal tibial bone loss is frequently encountered and can result in a less-stable bone-implant fixation. A 3D printed titanium alloy (Ti6Al4V) revision augment that conforms to the irregular shape of the proximal tibia was recently developed. The purpose of this study was to evaluate the fixation stability of rTKA with this augment in comparison to conventional cemented rTKA.

Eleven pairs of thawed fresh-frozen cadaveric tibias (22 tibias) were potted in custom fixtures. Primary total knee arthroplasty (pTKA) surgery was performed on all tibias. Fixation stability testing was conducted using a three-stage eccentric loading protocol. Static eccentric (70% medial/ 30% lateral) loading of 2100 N was applied to the implants before and after subjecting them to 5×103 loading cycles of 700 N at 2 Hz using a joint motion simulator. Bone-implant micromotion was measured using a high-resolution optical system. The pTKA were removed. The proximal tibial bone defect was measured. One tibia from each pair was randomly allocated to the experimental group, and rTKA was performed with a titanium augment printed using selective laser melting. The contralateral side was assigned to the control group (revision with fully cemented stems). The three-stage eccentric loading protocol was used to test the revision TKAs. Independent t-tests were used to compare the micromotion between the two groups.

After revision TKA, the mean micromotion was 23.1μm ± 26.2μm in the control group and 12.9μm ± 22.2μm in the experimental group. There was significantly less micromotion in the experimental group (p= 0.04). Prior to revision surgery, the control and experimental group had no significant difference in primary TKA micromotion (p= 0.19) and tibial bone loss (p= 0.37).

This study suggests that early fixation stability of revision TKA with the novel 3D printed titanium augment is significantly better then the conventional fully cemented rTKA. The early press-fit fixation of the augment is likely sufficient for promoting bony ingrowth of the augment in vivo. Further studies are needed to investigate the long-term in-vivo fixation of the novel 3D printed augment.


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_5 | Pages 129 - 129
1 Apr 2019
Lowther M Cox SC Grover L
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Introduction

Implant associated infections are responsible for over 10 % of recorded orthopaedic revision surgeries across the UK, with higher infection rates commonly observed for other endoprostheses such as cranioplasties. To prevent colonization and biofilm formation on implant surfaces, the use of silver coatings has shown positive results in clinical setting due to its synergistic function with conventional antibiotic prophylaxes. Additive manufacturing allows manufacture of entirely new implant geometries such as lattice structures to enhance osseointegration, however this limits the ability to uniformly coat implants. Direct integration of silver into the powder feedstock for selective laser melting (SLM) may allow manufacture of a biomedical alloy with innate, long lasting antimicrobial properties without compromising possible geometries and with no coating process necessary.

Methods

Feedstock powders of 15–45 micron Grade 5 Ti-64 (Renishaw Plc) and Ag-999 powder (CooksonGold) were characterized using laser particle size analysis, ICP-OES, LECO-ONH, and morphological analysis in SEM. A blend of Ti-64 with 3 wt% Ag-999 powder (Ti-643) was produced by tumble blending, and validated by SEM and EDS. Parameters for manufacture were established using a 17 point design of experiment (DoE) exploring a 2D parameter space of applied laser power and laser scanning speed. Samples were manufactured using a ConceptLaser M2 LaserCusing SLM. Density was assessed by He pycnometry, and cross-sections analysed for defects by optical microscopy. Silver distribution was mapped by micro X-Ray Fluoroscopy (µXRF) and energy-dispersive X-ray spectroscopy (EDS). Optimum parameters were identified and used to manufacture all subsequent samples.

Cylindrical Ti-643 samples were manufactured for further physical characterization and bacterial investigation, alongside control Ti-64 samples manufactured using existing optimum parameters. Samples were polished using silicon carbide papers to a 4000-grit surface finish. Contact angle measurements were made by goniometry. Silver elution characteristics were assessed by immersion in water refreshed on a daily basis, and sampled over a 14 day period using ICP-OES. Viability of S. aureus was compared to control samples according to the Japanese standard test method, JIS Z 2801:2000.


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_5 | Pages 85 - 85
1 Apr 2019
Dall'Ava L Hothi H Henckel J Cerquiglini A Laura AD Shearing P Hart A
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Introduction

The use of Additive Manufacturing (AM) to 3D print titanium implants is becoming widespread in orthopaedics, particularly in producing cementless porous acetabular components that are either custom-made or off-the-shelf; the primary design rationale for this is enhanced bony fixation by matching the porosity of bone. Analysis of these retrieved components can help us understand their performance; in this study we introduce a non-destructive method of the retrieval analysis of 3D printed implants.

Material and methods

We examined 11 retrieved 3D printed acetabular cups divided into two groups: “custom-made” (n = 4) and “off-the-shelf” (n = 7). A macroscopic visual analysis was initially performed to measure the area of tissue ongrowth. High resolution imaging of each component was captured using a micro-CT scanner and 3D reconstructed models were used to assess clinically relevant morphometric features of the porous structure: porosity, porous structure thickness, pore size and strut thickness. Optical microscopy was also used as a comparison with microCT results. Surface morphology and elemental composition of the implants were investigated with a Scanning Electron Microscope (SEM) coupled with an Energy Dispersive X-ray Spectroscope (EDS). Statistical analysis was performed to evaluate possible differences between the two groups.


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_1 | Pages 12 - 12
1 Feb 2021
Pianigiani S Verga R
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A common location for radius fracture is the proximal radial head. With the arm in neutral position, the fracture usually happens in the anterolateral quadrant (Lacheta et al., 2019).

If traditional surgeries are not enough to induce bone stabilization and vascularization, or the fracture can be defined grade III or grade IV (Mason classification), a radial head prosthesis can be the optimal compromise between bone saving and recovering the “terrible triad”.

A commercially available design of radial head prosthesis such as Antea (Adler Ortho, Milan, Italy) is characterized by flexibility in selecting the best matching size for patients and induced osteointegration thanks to the Ti-Por® radial stem realized by 3D printing with laser technique (Figure 1). As demonstrated, Ti-Por® push-out resistance increased 45% between 8 −12 weeks after implantation, hence confirming the ideal bone-osteointegration. Additional features of Antea are: bipolarity, modularity, TiN coating, radiolucency, hypoallergenic, 10° self-aligning.

The osteointegration is of paramount importance for radius, in fact the literature is unfortunately reporting several clinical cases for which the fracture of the prosthesis happened after bone-resorption. Even if related to an uncommon activity, the combination of mechanical resistance provided by the prosthesis and the stabilization due to the osteointegration should cover also accidental movements.

Based upon Lacheta et al. (2019), after axial compression-load until radii failure, all native specimens survived a compression-load of 500N, while the failure happened for a mean compression force of 2560N.

The aim of this research study was to test the mechanical resistance of a radial head prosthesis obtained by 3D printing. In detail, a finite element analysis (FEA) was used to understand the mechanical resistance of the core of the prosthesis and the potential bone fracture induced in the radius with simulated bone- resorption (Figure 2a). The critical level was estimated at the height for which the thickness of the core is the minimum (Figure 2b).

Considered boundary conditions:

- Full-length prosthesis plus radius out of the cement block equal to 60mm (Figure 2a);

- Bone inside the cement equal to 60mm (Figure 2b);

- Load inclined 10° epiphysiary component (Figure 2c);

- Radius with physiological or osteoporotic bone conditions;

- Load (concentrated in the sphere simulating full transmission from the articulation) of 500N or 1300N or 2560N.

Figure 3 shows the results in terms of maximum stress on the core of the prosthesis and the risk of fracture (Schileo et al., 2008).

According to the obtained results, the radial head prosthesis shows promising mechanical resistance despite of the simulated bone-resorption for all applied loads except for 2560N. The estimated mechanical limit for the material in use is 200MPa. The risk of fracture is in agreement with the experimental findings (Lacheta et al. (2019)), in fact bone starts to fail for the minimum reported failure load, but only for osteoporotic conditions.

The presented FEA aimed at investigating the behavior of a femoral head prostheses made by 3D printing with simulated bone-resorption. The prosthesis shows to be a skilled solution even during accidental loads.

For any figures or tables, please contact the authors directly.


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_8 | Pages 80 - 80
1 Aug 2020
Montgomery S Schneider P Kooner S
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Three dimensional printing is an emerging new technology in medicine and the current educational value of 3D printed fracture models is unknown. The delayed surgery and need for CT imaging make calcaneal fractures an ideal scenario for preoperative 3D printed (3Dp) fracture models. The goal of this study is to assess if improvements in fracture understanding and surgical planning can be realized by trainees when they are given standard CT imaging and a 3Dp model compared to standard CT imaging and a virtual 3D rendering (3D CT).

Ethics approval was granted for a selection of calcaneal fracture imaging studies to be collected through a practice audit of a senior orthopaedic trauma surgeon. 3Dp models were created in house. Digital Imaging and Communications in Medicine (DICOM) files of patient CT scans were obtained from local servers in an anonymized fashion. DICOM files were then converted to .STL models using the Mimics inPrint 2.0 (Materialise NV, Leuven, Belgium) software. Models were converted into a .gcode file through a slicer program (Simplify3D, Blue Ash, OH USA). The .gcode files were printed on a TEVO Little Monster Delta FDM printer (TEVO USA, CO USA) using 1.75mm polylactic acid (PLA) filament.

Study participants rotated through 10 workstations viewing CT images and either a digital 3D volume rendering or 3Dp model of the fractured calcaneus. A questionnaire at each workstation assessed fracture classification, proposed method of treatment, confidence with fracture understanding and satisfaction with the accuracy of the 3Dp model or 3D volume rendering. Participants included current orthopaedic surgery trainees and staff surgeons.

A total of 16 residents and five staff completed the study. Ten fracture cases were included in the analysis for time, confidence of fracture understanding, perceived model accuracy and treatment method. Eight fracture cases were included for assessment of diagnosis. There were no cases that obtained universal agreement on either Sanders classification or treatment method from staff participants. Residents in their final year of studies had the quickest mean time of assessment (60 +/− 24 sec.) and highest percentage of correct diagnoses (83%) although these did not reach significance compared to the other residency years. There was a significant increase in confidence of fracture understanding with increasing residency year. Also, confidence was improved in cases where a 3Dp model was available compared to conventional CT alone although this improvement diminished with increasing residency year. Perceived accuracy of the cases with 3Dp models was significantly higher than cases without models (7 vs 5.5 p < 0.0001).

This is the first study to our knowledge to assess trainee confidence as a primary outcome in the assessment of the educational value of 3Dp models. This study was able to show that a 3Dp model aides in the perceived accuracy of fracture assessment and showed an improvement in trainee confidence, although the effect on confidence seems to diminish with increasing residency year. We propose that 3D printed calcaneal fracture models are a beneficial educational tool for junior level trainees and the role of 3Dp models for other complex orthopaedic presentations should be explored.


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_4 | Pages 4 - 4
1 Apr 2019
Wilson C Inglis M George D
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Introduction

Revision total hip arthroplasty is a complex procedure and becoming more common. Acetabular implant loosening or fracture has previously been treated with a cup and cage construct. Recent studies have shown significant failure rates with Cup Cage constructs in more complex 3B and 3C Acetabular revisions. As a result the use of 3D printed custom made acetabular components has become more common.

Method

We present 5 cases with severe acetabular bone loss that were treated with 3D printed acetabular components. The components were manufactured by OSSIS medical in New Zealand. The patient's original femoral stem was retained in all cases. Pre operatively the implant design was approved by the arthroplasty team prior to final manufacture. Implants were provided with a sterilisable model used intraoperatively for reference.