To investigate the effectiveness of silver coated prostheses in preventing periprosthetic infection in a high-risk group. We have used silver coated prostheses in 48 endoprosthetic replacements in whom there would be a high expected risk of infection.Aim
Methods
Non-invasive expandable prostheses for limb salvage tumour surgery were first used in 2002. These implants allow ongoing lengthening of the operated limb to maintain limb-length equality and function while avoiding unnecessary repeat surgeries and the phenomenon of anniversary operations. A large series of skeletally immature patients have been treated with these implants at the two leading orthopaedic oncology centres in England (Royal National Orthopaedic Hospital, Stanmore, and Royal Orthopaedic Hospital, Birmingham). An up to date review of these patients has been made, documenting the relevant diagnoses, sites of tumour and types of implant used. 87 patients were assessed, with an age range of 5 to 17 years and follow up range of up to 88 months. Primary diagnosis was osteosarcoma, followed by Ewing's sarcoma. We implanted distal femoral, proximal femoral, total femoral and proximal tibial prostheses. All implants involving the knee joint used a rotating hinge knee. 6 implants reached maximum length and were revised. 8 implants had issues with lengthening but only 4 of these were identified as being due to failure of the lengthening mechanism and were revised successfully. Deep infection was limited to 5% of patients. Overall satisfaction was high with the patients avoiding operative lengthening and tolerating the non-invasive lengthenings well. Combined with satisfactory survivorship and functional outcome, we commend its use in the immature population of long bone tumour cases.
Infected mega-endoprostheses are difficult to treat with systemic antibiotics due to encapsulation of the implant by fibrous tissue, formation of biofilms and antibiotic resistant bacteria. Modifying the implant surface by incorporating a bactericidal agent may reduce infection. Infection rates are typically in the range of 8% to 30%. This study describes a novel process method of “stitching-in” ionic silver into the implant surface, A novel process has been developed to “stitch in” ionic silver into the upper surface of titanium alloy (Ti6Al4V). The process produces a modification by anodisation of the titanium alloy in dilute phosphoric acid, followed by absorption of silver from an aqueous solution. The engineered surface modification is therefore integral with the substrate and loaded with silver by an ion exchange reaction. Using this technique the maximum inventory of silver for typical a mega-prosthesis is 6mg and this is greater than 300 times lower than the No Observable Adverse Affects Level (NOAEL). Scanning electron microscopy revealed that the silver was concentrated in pits and forming reservoirs of ionic silver exposed to the body tissues. Laboratory-based studies focusing on the safety and efficacy of silver as a bactericidal agent have included investigation into cytotoxicity using fibroblast and osteoblast cell lines, the impact of silver in reducing corrosion and laboratory testing to establish if the modified surface has an effect on the wear and mechanical characteristics. A range of fatigue, static, tensile pull off tests were performed. The silver elution profiles for both silver loaded and HA coated over a silver loaded surface have been examined. Histological studies were also performed to examine the impact of the silver on osseointegration. The To date (May 10) 147 silver treated mega-prostheses have been implanted since March 2006. The majority of implants were distal femoral (29%), proximal tibial (23%) or hemiplevic (10%). The most common indication was revision of a failed limb salvage reconstruction (58%), with the dominant cause of failure being infection. The next most common indication was bone tumour (31%) and the large majority were used in the high risk skeletal locations of the tibia (44%) and the pelvis (27%). Early clinical results are encouraging indicating a significant reduction in the incidence of infection. Three implants have been retrieved. An analysis of a proximal humeral replacement that had been This novel process of “stitching-in” silver appears to be a safe and effective surface treatment in helping to control infections of mega-prostheses. This technology has the potential to be transferred to other arthroplasty joints.
Endoprosthetic reconstruction is an established method of treatment for primary bone tumours in children. Traditionally these were implanted with cemented intramedullary fixation. Hydroxyapatite collars at the shoulder of the implant are now standard on all extremity endoprostheses, but older cases were implanted without collars. Uncemented intramedullary fixation with hydroxyapatite collars has also been used in an attempt to reduce the incidence of problems such as aseptic loosening. Currently there are various indications that dictate which method is used. To establish long term survivorship of cemented versus uncemented endoprosthesis in paediatric patients with primary bone tumours.Background
Aims
Non-invasive expandable prostheses for limb salvage tumour surgery were first used in 2002. These implants allow ongoing lengthening of the operated limb to maintain limb-length equality and function while avoiding unnecessary repeat surgeries and the phenomenon of anniversary operations. A large series of skeletally immature patients have been treated with these implants at the two leading orthopaedic oncology centres in England (Royal National Orthopaedic Hospital, Stanmore, and Royal Orthopaedic Hospital, Birmingham). An up to date review of these patients has been made, documenting the relevant diagnoses, sites of tumour and types of implant used. 74 patients were assessed, with an age range of 7 – 16 years and follow up range of 4 – 88 months. We identified five problems with lengthening. One was due to soft tissue restriction which resolved following excision of the hindering tissue. Another was due to autoclaving of the prosthesis prior to insertion and this patient, along with two others, all had successful further surgery to replace the gearbox. Another six patients required mechanism revision when the prosthesis had reached its maximal length. Complications included one fracture of the prosthesis that was revised successfully and six cases of metalwork infection (two of which were present prior to insertion of the implant and three of which were treated successfully with silver-coated implants). There were no cases of aseptic loosening. Overall satisfaction was high with the patients avoiding operative lengthening and tolerating the non-invasive lengthenings well. Combined with satisfactory survivorship and functional outcome, we commend its use in the immature population of long bone tumour cases.
6 prostheses that used ball bearings to achieve length (designed in 1981) were implanted, 3 (50 %) were revised due to mechanical failure. 19 prostheses that utilised external C-washes (1998) to achieve length were implanted, 6 (32 %) were revised, half of these for mechanical failure. Of the 98 minimally invasive prostheses (1992) that utilized an Allan key and screw-jack mechanism to lengthen, 14 (14 %) were revised, half of these for infection. 17 non-invasive extendable endoprostheses (2001) that are lengthened by electromagnetic coupling have been implanted so far. There has only been 1 (6 %) revision. This was due to full extension being reached.
Key Words: Bone tumour, children, endoprosthesis, survivorship.
We have investigated whether improvements in design have altered outcome for patients undergoing endoprosthetic replacement of the distal femur following tumour resection. Survival of the implant and ‘servicing’ procedures has been documented using a prospective database and review of the implant design records and case records. A total of 335 patients underwent a distal femoral replacement with 162 having a fixed hinge design and 173 a rotating hinge. The median age of the patients was 24 years (range 13–82yrs). With a minimum follow up of 5 years and a maximum of 30 years, 192 patients remain alive with a median follow up of 11 years. The risk of revision for any reason was 17% at 5 years, 34% at 10 years and 58% at 20 years. Aseptic loosening was the most common reason for revision in the fixed hinge knees whilst infection and stem fracture were the most common reason in the rotating hinges. The risk of revision for aseptic loosening in the fixed hinges was 32% at ten years compared with 4% for rotating hinge knees with a hydroxyapatite collar. The overall risk of revision for any reason was halved by use of the rotating hinge.
Endoprosthetic reconstruction as a form of limb salvage in the management of malignant disease is common. We present our experience with custom-made distal femoral replacement as a form of limb salvage in the absence of malignancy. 49 cases of distal femoral replacement were identified using the unit database. There were 18 males and 31 females, with a mean age at operation of 62.3 years (range 26–86). There were 29 cases of failed total knee replacements, 8 cases of fracture associated with bone loss, non-union or deformity, 7 periprosthetic fractures, 3 aneurysmal bone cysts, and one case each of avascular necrosis and Gorham’s disease. Clinical and radiographic review of all available patients, including a functional assessment with the Musculoskeletal Tumour Society (MSTS) Score and Toronto Extremity Salvage (TES) score was undertaken. The average follow-up was 5.4 years (range 1 to 29 years). Three types of endoprosthesis were used, rotating hinge, fixed hinge and arthrodesis prosthesis. One patient required amputation at 2 months following post-operative wound infection with methicillin-resistant staphylococcus aureus and subsequent inability to provide adequate soft tissue coverage. There was one revision at 16 months for deep prosthetic infection. 21 patients were available for functional follow-up. The mean MSTS score was 63.7 (range 16.0–86.7) and the mean TES score was 59.4 (range 9.4–87.5). Custom-made distal femoral replacements have an established role in limb-salvage surgery for malignant disease. This series demonstrates the reconstructive capability of custom prostheses in non-malignant disease, where deformity causes functional embarrassment or when massive bone loss would normally lead to amputation.
The purpose of this study was to determine whether the low rate of mechanical loosening of the SMILES rotating hinge distal femoral endoprosthesis relates to the hydroxyapatite (HA)-coated, grooved collar of the femoral component. A database was used to identify two groups of cases of primary distal femoral replacement with a custom-designed and manufactured SMILES endoprosthesis at our unit; those with the collared femoral component (“collar group”), and those without a collar (“non-collargroup”). From these two groups, patients were pair-matched for age and length of bone resection. A retrospective review of serial biplanar pairs of radiographs of each patient, assessing radiolucent lines and extracortical bone pedicle. 11 matched pairs were identified, (14 females, 8 males), with a mean age of 36 years, (range 16–66). The pathology was primary bone tumour in 20 cases, (17 malignant, 3 benign), and metastatic disease in 2 cases. Mean length of follow-up was 85 months, (range 27–122). Radiolucent line score (RLS) progression over time was significantly lower in the collar group, (0.01 vs 0.73, p=0.001) (fig. 1 &
2), as was the mean final RLS, (2.72 vs 7.81, p=0.02). Mean RLS per radiographic quadrant was 0.56 in cases in which a bony pedicle was ingrown onto the prosthesis, (exclusively in the collared-group), 2.41 in cases in which the pedicle was not ingrown, (most prevalent in the non-collared group), and 1.02 in those cases without any pedicle formation, (ANOVA analysis, p=0.0002). This study demonstrates that the HA-coated, grooved collar significantly reduces the progression of radiolucent lines, and consequently the overall RLS, explaining the reduced rate of mechanical loosening of the collared endoprosthesis. A bony pedicle that does not incorporate onto the prosthesis surface may be associated with an increase in radiographic loosening.
The purpose of this study was to evaluate the results of custom-made endoprosthetic reconstruction for both tumourous and non-tumourous conditions around the elbow joint. 28 consecutive cases of endoprosthetic elbow reconstruction, performed between 1989 and 2003, were identified using the unit database. There were 12 males and 16 females, with a mean age 48.9 years, (range 14–84). There were 16 cases of malignant tumour (10 primary, 6 secondary), 3 cases of benign tumour (one each of giant cell tumour, osteoblastoma and pigmented villonodular synovitis) and 10 non-oncological cases, (5 cases of fracture, 3 failed total elbow replacements and 1 infected synostosis). A distal humeral prosthesis was used in 16 patients, distal humeral and proximal ulna in 10 patients, proximal ulna with a humeral component in one patient and proximal radial replacement in one patient. Clinical and radiographic review of all available patients, including a functional assessment with The Toronto Extremity Salvage score (TESS) was undertaken. 28 consecutive cases of endoprosthetic elbow reconstruction, performed between 1989 and 2003, were identified using the unit database. There were 12 males and 16 females, with a mean age 48.9 years, (range 14–84). There were 16 cases of malignant tumour (10 primary, 6 secondary), 3 cases of benign tumour (one each of giant cell tumour, osteoblastoma and pigmented villonodular synovitis) and 10 non-oncological cases, (5 cases of fracture, 3 failed total elbow replacements and 1 infected synostosis). A distal humeral prosthesis was used in 16 patients, distal humeral and proximal ulna in 10 patients, proximal ulna with a humeral component in one patient and proximal radial replacement in one patient. Clinical and radiographic review of all available patients, including a functional assessment with The Toronto Extremity Salvage score (TESS) was undertaken. Endoprosthetic reconstruction around the elbow joint is effective in a wide range of pathologies, allowing in most cases a reasonable level of function, even following two-stage revision for infection.
The use of a navigation system in musculoskeletal tumour surgery enables the integration of pre-operative CT and MRI images to generate a precise three-dimensional anatomical model of the site and the extent of the tumour. We carried out six consecutive resections of musculoskeletal tumour in five patients using an existing commercial computer navigation system. There were three women and two men with a mean age of 41 years (24 to 47). Reconstruction was performed using a tumour prosthesis in three lesions and a vascularised fibular graft in one. No reconstruction was needed in two cases. The mean follow-up was 6.9 months (3.5 to 10). The mean duration of surgery was 28 minutes (13 to 50). Examination of the resected specimens showed clear margins in all the tumour lesions and a resection that was exactly as planned.
Each of the two groups consisted of five males and four females, with mean age 48 years in group 1 and 49 years in group 2. The average follow-up since surgery in both groups was 10 years. The mean MSTS and stability scores of group 1 were 83% and 3.9 respectively, and 71% and 3.2 for group 2; the difference in scores between groups was statistically significant (p<
0.02).
The rate of infection was 12.5%, aseptic loosening 6%, amputation due to local recurrence 10% and the mortality 21%. All the deaths occurred within three years of the implant being inserted and were all due to systemic progression of the disease. The amputations for local recurrence occurred throughout the follow-up period, the latest being at 71 months. Revisions for infections and aseptic loosening all occurred early (within three years). All cases of aseptic loosening occurred in distal femoral replacements (10%) and were related to divergent canals. Proximal tibial replacements had the highest rate of infection (23%). Rates of infection were not higher in the minimally invasive grower (12.5 %) when compared to the group as a whole.
Metal-on-metal hip bearings are being implanted into younger patients. The consequence of elevated levels of potentially carcinogenic metal ions is therefore a cause for concern. We have determined the levels of cobalt (Co), chromium (Cr), titanium (Ti) and vanadium (Va) in the urine and whole blood of patients who had had metal-on-metal and metal-on-polyethylene articulations We found significantly elevated levels of whole blood Ti, Va and urinary Cr in all arthroplasty groups. The whole blood and urine levels of Co were grossly elevated, by a factor of 50 and 300 times respectively in patients with loose metal-on-metal articulations when compared with the control group. Stable metal-on-metal articulations showed much lower levels. Elevated levels of whole blood or urinary Co may be useful in identifying metal-on-metal articulations which are loose.
Retrospective analysis of all uncemented massive endoprostheses inserted at our unit in the management of primary bone tumours with a minimum follow up of 5 years.
The rate of infection was 12.5%, aseptic loosening 6%, amputation due to local recurrence 10% and the mortality 21%. All the deaths occurred within 3 years of the implant being inserted and were all due to systemic progression of the disease. The amputations for local recurrence occurred throughout the follow up period, the latest being at 71 months. Revisions for infections and aseptic loosening all occurred early (within 3 years). All cases of aseptic loosening occurred in distal femoral replacements (10%) and were related to divergent canals. Proximal tibial replacements had the highest rate of infection (23%). Rates of infection were not higher in the minimally invasive grower (12.5 %) when compared to the group as a whole.