Introduction. Bone loss management represents one of the most challenging issues for the orthopaedic surgeon. In most cases, stems, structural allograft, TMcones, and sleeves are adequate to allow optimal implant stability and durable fixation. In selected cases of wide metadiaphyseal bone defects, these devices do not provide proper intraoperative stability. In such scenarios, further steps are needed and include complex modular reconstruction, substitution with megaprosthesis (exposing patients at high risk of early failure) or joint arthrodesis that can yield unacceptable results. The aim of this paper is to present early results obtained with a new custom-made implant for complex metadiaphyseal bone defects management in knee revision surgery. By means of case presentations the authors would highlight the possibilities and technical notes of this novel device in complex knee revision surgery. Methods. Since2015, 8 custom-made porous titanium devices were implanted for massive bone defect management in 6 knee arthroplasty revision procedures. Five patients were staged revision for periprosthetic joint infection (PJI) and one patient underwent a staged revision for post-traumatic septic arthritis. Main demographic and surgical data were collected. Clinical (Range of Movement [ROM], Knee Society Score [KSS] and Oxford Knee Score [OKS]), radiological findings and complications were recorded at different time points and statistically evaluated. Mean follow up was 19.5 ± 9.6months. Results. The study group included 4 males and 2 females with a mean age of 63.7 ± 5.5 years and a mean Body Mass Index of 29.3 ± 4.1. Globally, the mean number of previous surgeries was 4.8 ± 2.7. The custom made device was combined with a hinged prosthesis in 5 cases and with a constrained condylar implant in 1 patient. Hybrid fixation was used in all cases. The mean KSS and OKS of the entire population improved significantly from 35.3 ±6.5 and 19.2 ±3.5 preoperatively to 85.8 ±4.0 and 39.3 ±3.1 at the time of last follow-up evaluation (p<0.01). The range of motion improved from 46.7 ±9.8 of mean preoperative flexion and 7.8 ±6.8 of mean preoperative flexion contracture to 93.3 ±10.3 and 1.2 ±2.9 respectively (p<0.01). Radiological analysis showed no migration or implant loosening. No intraoperative or postoperative complication was recorded. One patient required a prolonged antibiotic therapy for positive culture samples of sonication of the retrieved spacer. No implant mismatch between the preoperative planning and the final implant was reported. Conclusion. The presented custom-made implant showed promising early clinical and radiological results. In extremely selected cases, this new device can be considered a safe and effective surgical step between “off the shelf” reconstruction implants and knee substitution with a tumor megaprosthesis. Accurate surgical planning and intraoperative management of soft tissues and residual bone stock are of paramount importance

Introduction and Purposes. Custom made acetabular prosthesis are a valid option for the reconstruction after the resection of pelvic tumors. They should guarantee a stable and reliable reconstruction for the expected survival of the patient. Nevertheless in many cases periacetabular metastatic lesions have been compared to high grade (IIIA-B) Paprosky defects, but treated with low or intermediate longevity implants. Some complex post-traumatic scenarios or total hip arthroplasty (THA) multiple failures need a reconstruction according to oncologic criteria to fill in the huge defect and to obtain an acceptable function. The aim of the study is to compare 3D custom-made implants for tumors and for THA failures. Materials and Methods. Three custom-made implants after tumor resection (group A: 1 chondroblastic osteosarcoma, 1 bifasic synovialsarcoma, 1 high grade chondrosarcoma) were evaluated and compared to 3 acetabular complex reconstructions after non-oncologic bone defect (group B: 3 cases of aseptic loosening after at least 2 revisions). All the implants were case-based designed, 3D printed, and realized with porous or trabecular surfaces on a Titanium base prosthesis. Age range 16–70 ys in oncologic patients and 60–75 ys in non-oncologic patients. The bone defect to be reconstructed after tumor resection was classified according to Enneking zones (1 type 1-2-3 resection, 1 type 2 resection, 1 partial type 2 resection). Non-oncologic cases were comparable in term of remaining bone stock and classified according to Paprosky classification for acetabular defects as 1 type IIIA an 2 type IIIB. Complications, MSTS functional score, necessity of walking-aids were evaluated at minimum follow up of 1 year. Results. In both groups, good functional results were obtained (MSTS score 25/30 in both groups). No cases of aseptic loosening and no infection occured. After 3 months of partial or no weight-bearing on the operated limb, 3 patients were able to walk unaided and 3 walked with one cane or crutch. No limb length discrepancy (major than 2 cm) were observed. Limping was present in oncologic cases due to muscle resection. Overall better results in term of satisfaction and quality of life were obtained in younger (oncologic) patients. Conclusions. Complex THA revision cases can sometimes be considered for a reconstruction with oncologic criteria. Even if indications are limited an acceptable functional results can be obtained. In the past for these cases a Girldestone resection was the only option. A collaboration among orthopaedic oncologist and hip arthroplasty surgeons is advisable in major orthopaedic centers to improve the prosthetic design and the functional results

Total Knee Arthroplasty (TKA) patients may present with effusion, pain, stiffness and functional impairment. A positive metal hypersensitivity (positive LTT) may be an indication for a revision surgery with a custom-made implant devoid of any hypersensitivity-related metal or an implant with the least possible ion content of the metal hypersensitivity, if no custom-made is available. The purpose of the current study is to assess the prevalence of metal hypersensitivity in subjects requiring a primary TKA and assess their early functional outcomes. We are recruiting 660 subjects admitted for TKA. Subjects are randomly assigned to 2 groups: oxidized zirconium implant group or cobalt-chrome implant group. Functional outcomes and quality of life (QoL) are measured pre operatively, 3, 6 and 12 months post operatively with WHOQOL-BREF (domain1-Physical Health, domain 2- Psychological, domain 3- Social relationships, domain 4-Environment), KSS, KOOS and pain Visual Analog Scale (VAS). LTT and metal ions are evaluated pre operatively and 12 months post-surgery. One hundred-sixty patients, 98 women, were enrolled in the study. Mean age was 65.6±8.9. Mean follow up (FU) was 7.1±3.8 months. Eighty-one (50.6%) were randomised in the cobalt-chrome group. Infection rate was 1.9%, one patient required debridement. Three patients (1.9%) presented with contracture at three months FU. At 12 months, WHOQOL-BREF domain 1, 2 and 4 improved significantly (p0,05). Overall, all 160 patients improved their functional outcomes and QoL. At 12 months, VAS scores decreased from 7±2.06 at baseline to 1.95±2.79. Furthermore, the high prevalence of positive LTT (27/65) do not seem to affect early functional outcomes and QoL on patients that may have received a potential implant with hypersensitivity (18/27)

Most acetabular defects can be treated with a cementless acetabular cup and screw fixation. However, larger defects with segmental bone loss and discontinuity often require reconstruction with augments, a cup-cage, or triflange component – which is a custom-made implant that has iliac, ischial, and pubic flanges to fit the outer table of the pelvis. The iliac flange fits on the ilium extending above the acetabulum. The ischial and pubic flanges are smaller than the iliac flange and usually permit screw fixation into the ischium and pubis. The custom triflange is designed based on a pre-operative CT scan of the pelvis with metal artifact reduction, which is used to generate a three-dimensional image of the pelvis and triflange component. The design of the triflange involves both the manufacturing engineer and surgeon to determine the most appropriate overall implant shape, screw fixation pattern, and cup location and orientation. A plastic model of the pelvis, and triflange implant can be made in addition to the triflange component to be implanted, in order to assist the surgeon during planning and placement of the final implant in the operating room. A wide surgical exposure is needed including identification of the sciatic nerve. Proximal dissection of the abductors above the sciatic notch to position the iliac flange can risk denervation of the abductor mechanism. Blood loss during this procedure can be excessive. Implant survivorship of 88 to 100% at 53-month follow-up has been reported. However, in a series of 19 patients with Paprosky type 3 defects, only 65% were considered successful. The custom triflange also tends to lateralise the hip center which may adversely affect hip mechanics. The use of a triflange component is indicated in cases with massive bone loss or discontinuity in which other reconstructive options are not considered suitable

The Total Knee Replacement (TKR) has been used as the effective treatment for osteoarthritis of the knee. The load of the knee joint is generally applied at the heel strike as the impact loading. In the elderly who had muscle weakness or weakening eyesight, it can be anticipated that more excessive loads are often added to the knees when they stumble or trip over. And the varus / valgus alignments of the femur and tibia differs among patients. However, most finite element analyses considering the effect of the alignments have rarely been performed. In this study, the mounting angle of the tibia component in the TKR knee was changed, and the effect of the change on the load transfer was assess using finite element analyses. Based on the CT images, the three-dimensional finite element models of the natural knee joint and TKR knee joint were created [Fig. 1]. Each model was constructed from hexahedoral elements with the isotropic material. The numbers of nodes and elements were 10,666 and 8,677 respectively. Under normal alignment, 5 degrees of varus, and 5 degrees of valgus knee, the static analyses at an applied load of 1000N and impact analyses at an applied load of 50 kg were performed. LS-DYNA ver760 software was used for the analyses. The finite element analyses results showed that under the static loading, no stress shielding was observed in the tibial cancellous bone of the intact knee or TKR knee, and the maximum compressive stress was 1.5 MPa. While under the impact loading, the compressive stress generated inside of the cancellous bone was three times higher in the TKR knee joint than that in the intact knee, and the load transfer time was reduced. This result reveals that the cancellous bone have load bearing function especially in the impact condition. When the impact load was applied to the varus and valgus TKR knee, the stress shielding was observed in the tibial cancellous bone, especially in the varus condition. In a case where the tibia component was mounted by tilting it at −5 to 5 degrees depending on the varus/valgus of the knee, the stress shielding was alleviated; the distribution of load was almost the same as that of the TKR knee joint model under the normal alignment [Fig.2]. The effect of a slight difference in the alignment on the stress distribution is expected to be a contributor to determine artificial knee joint shape, loading condition, and other design factors in developing revision arthroplasty or custom-made implant

Introduction. We discuss the use of the SMILES (Stanmore Modular Individualised Lower Extremity System) in salvage revision knee surgery and review the medium-long term results of 42 cases. Methods. This is a prospective, single-centre study. The SMILES prosthesis is a custom-made implant incorporating a rotating hinge knee joint. 42 prostheses were used in 40 patients as salvage revision procedures between September 1991 and September 1999. Patients undergoing surgery for tumours were excluded. The minimum follow-up was seven years with a mean follow-up of ten years and six months. Patients were independently assessed using the Knee Society Rating Score. The age of the patients ranged from 36-85 years (mean 68 years and 6 months). 23 of the patients were male. The original pathology was osteoarthritis in 32 patients and rheumatoid arthritis in 8 patients. The number of previous arthroplasties ranged from 1-4. The main indications for a SMILES prosthesis were aseptic loosening, periprosthetic fracture and infection in the presence of bone loss and ligamentous laxity. Results. There was a highly statistically significant improvement in overall Knee Society scores from a mean of 26 pre-op to 72 post-op. The mean knee score improved from 26 pre-op to 68 post-op while the mean function score improved from 27 to 75. The average range of motion was 60 degrees pre-op and 90 degrees post-op. Complications included: failure to eradicate infection in two patients, with one patient needing amputation; infection of the prosthesis leading to revision in one, and failure of the tibial component needing revision. Conclusion. The SMILES has produced satisfactory results in the medium to long term, offering an alternative to amputation in some cases. The cost compares favourably with other designs and the use is increasing in frequency

Objective:. Patient-specific or “custom” total knee replacements have been designed to fit the arthritic knee in primary total knee arthroplasty (TKA) better than “off-the-shelf” implants. Using computer technology, patient-specific cutting-blocks and custom-made implants are created to more accurately fit the contour of the knee and reproduce the anatomic J-curve with the hope of providing a better functional outcome. Purpose:. This retrospective, matched-pair study evaluates manipulation under anesthesia (MUA) rates in cemented patient-specific cruciate-retaining (PSCR) TKA compared to that in both cemented posterior-stabilized (PS) and non-cemented cruciate-retaining rotating-platform (NC CR RP) TKA. Materials and Methods:. From 2010 through November of 2012, 21 PSCR TKAs were performed in 19 patients. Using medical records from our patient database, these patients were matched for age, side, deformity, diagnosis, Charnley Class, and preoperative range of motion (ROM) with 42 PS TKAs performed during the same time period by the same surgeon using the same intra- and post-operative protocols. Additionally, 11 NC CR RP TKA were performed and evaluated based on the same criteria. Pre- and postoperative radiographs were performed using criteria as described by The Knee Society. Results:. Preoperatively the custom CR RP TKA cohort had a larger average ROM compared to the PS TKA cohort (P-value = 0.006). Postoperatively, however, the custom CR RP TKA cohort overall was found to have a significantly decreased average ROM compared to both the PS and NC CR RP TKA cohorts (2.0°–110.6° P-value = 0.0002 and 2.4°–117.3° P-value = 0.0003, respectively). 6 of the 21 (28.6%) PSCR TKAs performed underwent MUA to improve postoperative ROM. One manipulation was unsuccessful and the patient is scheduled for revision for arthrofibrosis. No patients in either the matched PS group or the CR RP group underwent postoperative MUA. Clinical and radiographic analysis including pre-operative ROM, deformity, side, Charnley Class, posterior tibial slope angle, epicondylar axis and posterior condylar offsets provided no insight into the reason for this higher MUA rate in the PSCR knees. Conclusion:. MUA rates in the patient-specific TKA group were significantly higher than that in the matched PS and NC CR RP groups. No correlations were found to clearly indicate the cause of the higher MUA rate among the PSCR knees. Early manipulation is recommended for stiffness with these custom devices. Level of Evidence: Level III, Retrospective comparative study. Keywords: Patient-specific total knee, Manipulation, TKA

Clinically applied methods of assessing implant fixation and implant loosening are of sub-optimal precision, leading to the risk of unsecure indication of revision surgery and late recognition of bone defects. Loosening diagnosis involving measuring the eigenfrequencies of implants has its roots in the field of dentistry. The changing of the eigenfrequencies of the implant-bone-system due to the loosening state can be measured as vibrations or structure-borne sound. In research, vibrometry was studied using an external shaker to excite the femur-stem-system of total hip replacements and to measure the resulting frequencies by integrated accelerometers or by ultrasound. Since proper excitation of implant components seems a major challenge in vibrometry, we developed a non-invasive method of internal excitation creating an acoustic source directly inside the implant. In the concept proposed for clinical use, an oscillator is integrated in the implant, e.g. the femoral stem of a total hip replacement. The oscillator consists of a magnetic or magnetisable spherical body which is fixed on a flat steel spring and is excited electromagnetically by a coil placed outside the patient. The oscillator impinges inside the implant and excites this to vibrate in its eigenfrequency. The excitation within the bending modes of the implant leads to a sound emission to the surrounding bone and soft tissue. The sound waves are detected by an acoustic sensor which is applied on the patient's skin. Differences in the signal generated result from varying level of implant fixation. The sensor principle was tested in porcine foreleg specimens with a custom-made implant. Influence of the measurement location at the porcine skin and different levels of fixation were investigated (press-fit, slight loosening, advanced loosening) and compared to the pull-out strength of the implant. Evaluation of different parameters, especially the frequency spectrum resulted in differences of up to 12% for the comparison between press-fit and slight loosening, and 30% between press-fit and advanced loosening. A significant correlation between the measured frequency and the pull-out strength for different levels of fixation was found. Based on these findings, an animal study with sensor-equipped bone implants was initiated using a rabbit model. The implants comprised an octagonal cross-section and were implanted into a circular drill hole at the distal femur. Thereby, definite gaps were realized between bone and implant initially. After implantation, the bone growth around the implant started and the gaps were successively closed over postoperative period. Consequently, since the tests had been started with a loose implant followed by its bony integration, a reverse loosening situation was simulated. In weekly measurements of the eigenfrequencies using the excitation and sensor system, the acoustic signals were followed up. Finally, after periods of 4 and 12 weeks after implantation, the animals were sacrificed and pull-out tests of the implants were performed to measure the implant fixation. The measured implant fixation strengths at the endpoint of each animal trial were correlated with the acoustic signals recorded

Background. The procedures of total elbow and shoulder replacements increased 6% to 13% annually from 1993 to 2007 with revision-related burden increasing from 4.5% to 7%. The revisions of the shoulder and elbow prostheses due to aseptic loosening, periprosthetic fractures, infections have led to the use of standard or custom-made implants due to significant bone loss. This study reports our experience in the management of complicated primary and revisions of total shoulder and elbow replacements with significant humeral bone loss and in metabolic diseases of the elbow and shoulder treated with bone resection using The Mosaic Humeral Replacement System. Patients and Materials. A total of 20 patients underwent total elbow or shoulder arthroplasty using the Mosaic Humeral Replacement System (Biomet, UK). The Mosaic system was used in 8 shoulder arthroplasties (Group A) and in 12 elbow arthroplasties (Group B). The underlying pathologis in Group A included 2 malunited proximal humerus fracture, 1 humeral osteomyelitis, 1 shoulder chondrosarcoma, 1 aggressive Gigantic Cell Tumor with prosthetic fracture, 2 metastatic lytic lesion, and 1 failed fixation of non-union proximal humerus. Figure 1 shows Mosaic implant after complex fracture of proximal humerus. Reasons for Mosaic arthroplasty in Group B included 3 humeral component revisions due to periprosthetic fracture, 1 prosthesis breaking-up with fractures, 1 revision of loose Souter Strathclyde prosthesis, 1 loose prosthesis due to infection, 1 highly comminuted elbow fracture, 1 aseptic loosening of humeral component of total elbow replacement, 3 revision of total elbow replacement due loosening and 1 pathological distal humerus fracture due to metastasis. Figure 2&3 shows pre- and post-operative Mosaic implant following complex periprosthetic fracture of distal humerus. Clinical Observation/Discussion. The Mosaic Humeral Replacement System is a complete system for complex revision, salvage/oncology, and complex humeral fractures. It is a completely modular system which can be adapted to different patient anatomies and indications. It has been designed to face several surgical challenges, including reattaching soft tissues, properly tensioning the glenohumeral joint and restoring joint function. It is a cost-effective procedure with the benefits of a custom made humeral component in a standard tray. Our study shows that good results can be achieved with this form of treatment. Radiological assessment of all patients showed a satisfactory position of the implant with appropriate margin of bony resection. One patient with proximal and another one with distal humeral Mosaic replacement had late infection. One patient had aseptic loosening 3 years after distal humeral replacement. Most of the patients had satisfactory improvement in range of movement and chronic pain. While primary clinical observations and imaging results indicate acceptable results with Mosaic arthroplasty; a realistic assessment can only be achieved in long-term using the appropriate outcome measures. At the present we continue to regularly assess the patients clinically and radiologically and by means of Liverpool elbow score for distal and Quick- DASH for proximal Mosaic Humeral Replacement System and plan to report the long-term results in due time

The number of joint revision surgeries is rising, and the complexity of the cases is increasing. In 58% of the revision cases, the acetabular component has to be revised. For these indications, literature decision schemes [Paprosky 2005] point at custom pre-shaped implants. Any standard device would prove either unfeasible during surgery or inadequate in the short term. Studies show that custom-made triflanged implants can be a durable solution with good clinical results. However, the number of cases reported is few confirming that the device is not in widespread use. Case Report. A patient, female 50 yrs old, diagnosed having a pseudotumor after Resurfacing Arthroplasty for osteo-arthritis of the left hip joint. The revision also failed after 1 y and she developed a pelvic discontinuity. X-ray and Ct scans were taken and sent to a specialized implant manufacturer [Mobelife, Leuven, Belgium]. The novel process of patient-specific implant design comprises three highly automated steps. In the first step, advanced 3D image processing presented the bony structures and implant components. Analysis showed that anterior column was missing, while the posterior column was degraded and fractured. The acetabular defect was diagnosed being Paprosky 3B. The former acetabular component migrated in posterolateral direction resulting in luxation of the joint. The reconstruction proposal showed the missing bone stock and anatomical joint location. In the second step, a triflanged custom acetabular metal backing implant was proposed. The bone defect (35ml) is filled with a patient-specific porous structure which is rigidly connected to a solid patient-specific plate. The proposed implant shape is determined taking into account surgical window and surrounding soft tissues. Cup orientation is anatomically analyzed for inclination and anteversion. A cemented liner fixation was preferred (Biomet Advantage 48mm). Screw positions and lengths are pre-operatively planned depending on bone quality, and transferred into surgery using jig guiding technology (Materialise NV, Leuven, Belgium). In the third step, the implant design was evaluated in a fully patient-specific manner in dedicated engineering (FEA) software. Using the novel automated CT-based methodology, patient-specific bone quality and thickness, as well as individualised muscle attachments and muscle and joint forces were included in the evaluation. Implants and jig were produced with Additive Manufacturing techniques under ISO 13485 certification, using respectively Selective Laser Melting (SLM) techniques [Kruth 2005] in medical grade Ti6Al4V material, and the Selective Laser Sintering technique using medical grade epoxy monomer. The parts were cleaned ultrasonically, and quality control was performed by optical scanning [Atos2 scanning device, GOM Intl. AG, Wilden, Switzerland]. Sterilization is performed in the hospital. CONCLUSION. A unique combination of advanced 3D planning, patient-specific designed and evaluated implants and drill guides is presented. This paper illustrates, by means of a clinical case, the novel tools and devices that are able to turn reconstruction of complex acetabular deficiencies into a reliable procedure