SEARCH · Search PubMed
Search indexed PubMed citations on genomics, clinical trials, systematic reviews and public health. Explore titles, authors and supplied subject terms, then open the PubMed record.
Quote a phrase for an exact phrase match. Source license links do not imply unrestricted reuse.
We present two cases of Rotaflex hinged total knee arthroplasties in which the components forming the hinge mechanism have fractured. In one case this was the high density polyethelene sleeve bush of the tibial bearing, the other case being the titanium retaining peg of the tibial component. Component failure in this design of prosthesis is previously unreported.
BACKGROUND: Maintenance of wire pretension in an Ilizarov external fixator is dependent on the torque applied to the fixation bolts. We therefore measured immediately after surgery the clinically applied torques. The median value was only 10 N m (range 8-14N m). We wondered whether this value is appropriate to maintain the wire pretension and thereby to achieve sufficient fracture stability during dynamic loading of the device for a longer period. METHODS: A material testing machine dynamically loaded one wire mounted on one ring. Several configurations were tested. RESULTS: A quick decrease in wire tension to a steady state situation was seen. In the most stable configuration (20 N m wire fixation torque) 50% of the initial 90 kg wire pretension remained after dynamic loading with 200 N. In the least stable configuration (10 N m torque) considerable wire slippage occurred even without loading and no tension remained after loading! No plastic deformation of the wires was observed so loss of wire tension was due to slippage of the wires through the fixation bolts. INTERPRETATION: With the small fixation torques used in clinical practice considerable wire tension is lost even after a few loading cycles. Further research should address the question whether preservation of a higher wire tension during long term loading promotes faster fracture healing.
The AbioCor implantable replacement heart (IRH) is the first available totally implantable artificial heart. We recently initiated a multicenter trial of this device in patients with severe, irreversible biventricular failure. Patients who were not candidates for other therapies, including transplantation, were evaluated. All candidates were adults with inotrope-dependent biventricular failure, whose 30-day predicted mortality was higher than 70%. A three-dimensional computerized fit study predicted fit of the AbioCor thoracic unit in all recipients. At operation, the internal battery controller and transcutaneous energy transfer unit were placed. The AbioCor thoracic unit was placed in an orthotopic position after incision of the ventricals. There were 2 intraoperative deaths (due to intraoperative bleeding or aprotinin reaction). Four late deaths were recorded, 1 from multisystem organ failure and 3 cerebrovascular accidents. Autopsy revealed thrombus on the atrial struts of the 3 patients with cerebrovascular accident. Blood pumps and valves were clean on all patients. Significant morbidity was observed, primarily related to preexisting severity of illness. However, 3 patients recovered to the point of being able to take multiple trips outside of the hospital. Two patients were discharged from the hospital, with 1 patient being discharged home for more than 7 months. No significant device malfunctions or multi-system organ failure device-related infections were noted. The AbioCor IRH may be effective therapy for patients with end-stage heart failure. Many milestones have been achieved in the initial trial in humans, including the successful discharge of a patient to home and no significant device malfunctions. The occurrence of stroke is likely related to the presence of thrombus on the atrial struts and may be decreased as these atrial struts have been removed for future clinical implants.
Prosthetic ligaments of the knee have been very popular in the eighties. It took a number of years to become aware of the fact they are unable to provide long term stability to the knee joint. This report reviews the development of these prostheses, and tries to analyze the reasons for their failure and to find out why it took such a long time to demonstrate this failure, in order to draw a lesson from the past.
STUDY DESIGN: A clinical case series of 4 patients undergoing anterior lumbar revision due to failure of total disc replacement surgery. OBJECTIVES: To assess the clinical significance of polyethylene wear debris in salvage surgery after initial total disc replacement, the pattern and the mechanisms of polyethylene wear in the retrieved cores, and the extent of polyethylene debris in the periprosthetic tissues obtained from 4 patients. SUMMARY OF BACKGROUND DATA: Previous in vitro wear tests have demonstrated low wear rates for lumbar artificial discs, suggesting that implant wear may not be a clinically relevant issue with total disc replacement. However, only long-term clinical investigations with analysis of retrieved implants and periprosthetic tissue can ultimately establish the significance of polyethylene wear debris for total disc arthroplasty. METHODS: Starting in 2004, we began routinely performing salvage procedures in patients with failed total disc replacements. We report on the short-term outcomes of 4 patients at our institution who were revised with a Charité prosthesis (DePuy Spine, Raynham, MA). Wear analysis of the retrieved prosthesis and histologic examination of the periprosthetic tissue were also performed. RESULTS: All of the retrieved polyethylene cores showed evidence of wear, but the extent and severity varied among the 4 patients. Wear and fracture of the core were associated with osteolysis of the underlying sacrum in 1 patient. Histologic examination of the periprosthetic tissues confirmed the presence of wear debris lying in inflammatory fibrous tissue. In 3 of the 4 patients, implant wear was associated with an unfavorable biomechanical environment (e.g., subsidence, migration, undersizing, and adjacent fusion). The mechanisms of wear included adhesive/abrasive wear of the central domed region of the polyethylene core, as well as chronic rim impingement, resulting in rim fatigue and fracture. CONCLUSIONS: This study demonstrates the clinical significance of polyethylene wear debris and the potential for osteolysis with total disc replacements. The authors recommend that patients undergoing lumbar disc arthroplasty receive long-term follow-up to monitor the wear and functional status of their implants.
Explore the source record for details and available documents.
PURPOSE OF THE STUDY: Rotatory malposition of the femoral component of a unicompartmental knee arthroplasty (UKA) is a key element of mechanical failure despite proper alignment and position of the tibial implant. The purpose of this study was to describe a method for measuring femoral implant rotation on the anteroposterior x-ray using an original geometric model. MATERIAL AND METHODS: 276 medial UKA (227 non-cemented Uni Goeland, Depuy; Uni, AMP) and 49 cemented (Miller-Galante, Zimmer) were reviewed and analyzed at a mean 11 years (range 7 - 15) using the Knee Society Score. Mean objective and functional scores were 43 and 47 points preoperatively. Postoperative alignment and position of the femorotibial contact point were determined. The frontal and sagittal position of the tibial plateau was noted by the angle formed with the mechanical axis. Angles alpha and B of the femoral implant formed between the mechanical axis and the greater condylar axis and the inferior condylar line passing through the apex of the condylar convexity respectively were measured on the AP view. Frontal rotation (angle B) of the femoral implant reflected the orientation of the distal condylar cut. The frontal measurement (angle alpha) was validated using simple geometric formulas: knowing angles alpha and B and the size of the implant and the displacement of the point of contact was measured together with the true rotation of the femoral implant or anteroposterior divergence, function of the difference alpha-B which is its frontal projection and reflects the orientation of the posterior condylar cut. RESULTS: Mean alignment was 3 degrees varus. At last follow-up, outcome was satisfactory in 81.2% of the knees (224 UKA). Mean objective and functional scores were 90 and 87 points. Angles alpha and B were parallel and orthogonal to the mechanical axis or off by less than 4 degrees external rotation (+6 degrees to -4 degrees). The mean difference alpha-B (frontal projection of the femoral implant transverse rotation) was 1 degrees. The point of contact was 4 mm or less from the middle of the tibia. Failures were observed in 18.8% of knees (52 UKA): 4 for diverse reasons and 48 for mechanical failure, including 3 with polyethylene wear without loosening (two by eccentric point of contact and neutral position and one by inverted misalignments). 45 UKA (16.3%) presented loosening of the tibial plateau alone with rotatory femoral malposition: mean a angle off 13% from the mechanical axis (+16 degrees to -9 degrees ), mean B angle off 8 degrees (+12 degrees to -8 degrees), mean alpha-B difference 5 degrees , femoral implant in square position on polyethylene with a peripheral point of contact > or 5 mm from the middle of the tibial plateau. The tibial implant exhibited mean varus of 1.5 degrees. DISCUSSION: The main cause of failure was rotatory malposition of the condylar implant often associating frontal with transversal rotation. This increased mediolateral translation of the point of contact during knee motion causing abrasion and excessive pressure on the medial portion of the plateau. Frontal malrotation externalizes the posterior cut on the condyle tilted by the varus position, without correcting the varus of the mechanical axis in flexion. To avoid such prosthetic malrotations, three corrections must be made before making the bone cuts: cancel the external rotation of the condyles in flexion by positioning the distal cut guide in extension; re-establish the mechanical axis by reducing the internal tilt of the condyles resulting from the varus position both in extension (distal cut) and flexion (posterior cut). Improved instrumentations and reproducible techniques are needed to re-establish the 3D anatomic orientation of the femoral component, a key element for longer life of unicompartmental prostheses. This method for measuring the rotation of the femoral implant and the displacement of the point of contact using a geometric model applied to the AP view is useful for better understanding UKA failures.
OBJECTIVE: Hydrostatic devices have considerable advantages compared to "conventional" differential-pressure-valves concerning overdrainage, but are thought to imply a tendency to underdrain or to clog. The aim of this study was to evaluate the ability of the hydrostatic gravitational Dual-Switch-Valve (DSV) to minimize overdrainage-related complications without increasing the danger of underdrainage. RESULTS: In a series of 202 adult patients with different etiologies treated with a ventriculo-peritoneal shunt including the hydrostatic Dual-Switch-valve (DSV), 21 cases were suspected of suffering from underdrainage. Using a new algorithm we were able to differentiate obstruction in 6 patients from functional underdrainage in 15 cases, thus we saw an indication to reimplant a DSV with a lower opening pressure in the latter. CONCLUSION: The reasons for functional underdrainage were multifold in our series, especially the intraperitoneal pressure is still a "black box". Despite the ability of the DSV to avoid clogging and to minimize overdrainage by its high-pressure-chamber, it remains difficult to determine the optimal opening pressure of the low-pressure-chamber of the DSV for ideal clinical improvement. Therefore a new hydrostatic gravitational "programmable" valve (proGAV), entitled on avoiding the disadvantages of other adjustable devices, has been developed and implanted in 16 patients with promising results.
Rigorous preclinical testing of cemented hip prostheses against the damage accumulation failure scenario will reduce the incidence of aseptic loosening. For that purpose, a finite element simulation is proposed that predicts damage accumulation in the cement mantle and prosthetic migration. If the simulation is to become a convincing preclinical test, it should be able to distinguish between implants in a clinically relevant way, based on accurate predictions of long-term failure mechanisms of cemented hip prostheses. The algorithm was used to simulate long-term fatigue experiments on femoral reconstructions with Mueller Curved and Lubinus SPII stems. Clinically, the Mueller Curved system performs inferior to the Lubinus SPII system. The finite element simulation predicted much more cement damage around the Mueller Curved stem and showed that the entire cement mantle was involved in the failure process, which was not the case around the Lubinus SPII stem. In addition, the Mueller Curved stem was predicted to migrate more than the Lubinus SPII. The predictions showed excellent agreement with the experimental findings: similar damage locations in the cement, more damage for the Mueller Curved, similar prosthetic migration directions, and more migration for the Mueller Curved stem. This is the first time that a finite element simulation is able to differentiate between a clinically superior and an inferior implant, based on accurate simulation of the long-term failure mechanisms in a cemented reconstruction. Its use for preclinical testing purposes is corroborated.
OBJECTIVE: To determine the safe distance for distal femoral fractures relative to the distal locking screws in antegrade intramedullary femoral nailing using a currently available titanium alloy nail design. DESIGN: Cyclic (fatigue) mechanical testing study. SETTING: Biomechanics laboratory. INTERVENTION: Intramedullary nailing of left synthetic fiberglass composite femora with type 32/33-C fractures at 1, 2, 3, and 4 cm from the more proximal of the distal locking screws. MAIN OUTCOME MEASUREMENT: The number of loading cycles to failure of the nail. RESULTS: A load level of 700 N through the femoral mechanical axis was validated as adequate to cause fatigue failure within 200,000 cycles in slotted stainless- steel nails. In the nonslotted titanium alloy nails, this load level caused failure in only 1 of 3 nails with a fracture at 2 cm from the more proximal of the 2 distal locking screws and in 2 of 3 nails with a fracture at 1 cm from the more proximal of the 2 distal locking screws. All of the other nails did not fail >1 million cycles. CONCLUSIONS: Under laboratory conditions, it is safe to assume that an antegrade titanium alloy nail will survive 1 million compression/bending cycles when the fracture is > or = 3 cm from the more proximal of the 2 distal locking screws.
A 75-year-old with a history of coronary bypass grafting was found to have significant stenoses in a vein graft to the right coronary artery. Symbiot stents, with a polytetrafluoroethylene covering, were used to treat areas in the proximal and middle sections of the graft. The following day, she developed symptoms and signs consistent with an acute inferior infarction. The graft was found to be thrombosed. Thrombectomy was performed using an X-Sizer device, consisting of a helical cutter connected to a vacuum source. This resulted in damage to the stent lining, which led to jamming of the device and subsequent removal of a piece of the stent covering. Treatment was by way of deployment of a long stent within the damaged stent. Recovery was unremarkable. Caution or avoidance of this device appears warranted in the setting of covered stent procedures.
Explore the source record for details and available documents.
In this study, the potential of high-quality amorphous diamond (AD) coatings in reducing the torque and failures of bone screws was studied. Torque values were recorded for 32 stainless steel screws, 2.7 or 3.5 mm in diameter and 60 mm in length. Half of the screw sets were coated with the AD coating before installing in predrilled holes of human cadaveric femoral bone samples. The bone samples were selected from two groups of four persons with mean ages of 34 years (range 25-41 years) and 75 years (range 73-77 years), respectively. The bone mineral density (BMD) values of the samples were determined exactly at the screw insertion site by peripheral quantitative computed tomography (pQCT). In the mechanical tests, insertion and removal torques were measured. BMD had a significant effect on insertion torque; the maximum torque (adjusted with respect to the screw diameter) was significantly higher for the young bone than for the old bone (p < 0.05). By using a polished AD coating, insertion torque was decreased even up to 50% in comparison with the screws without coating. The results suggest that AD coating provides a stable, smooth surface and reduces the risk of screw failures.
PURPOSE: Reduced lead diameter and reliability can be designed into transvenous permanent pacing leads through use of redundant insulation and removal of the stylet lumen. The model 3830 lead (Medtronic Inc., Minneapolis, MN, USA) is a bipolar, fixed-screw, steroid-eluting, lumenless, 4.1-Fr pacing lead. Implantation can be performed in a variety of right heart sites using a deflectable catheter (Model 10600, Medtronic). Lead performance and safety were studied. METHODS: Two prospective trials of 338 implanted subjects from 56 global sites were conducted. Electrical and safety data were obtained at implant, pre-discharge, and up to 18 months post-implant. Leads were implanted at traditional and alternate right heart sites. RESULTS: The study enrolled 338 subjects (204 males, 70.6 +/- 11.6 years) followed-up for a mean of 10.2 months (range, 0-21.6). Mean P-wave amplitudes ranged from 3.2 mV at 3 months to 2.9 mV at 18 months, while mean atrial pulse width thresholds at 2.5 V ranged from 0.07 ms at 3 months to 0.09 ms at 18 months. Mean R-wave amplitudes ranged from 11.3 mV to 11.1 mV and mean ventricular pulse width thresholds at 2.5 V ranged from 0.10 ms to 0.14 ms. There were 22 ventricular and 12 atrial lead complications within 3 months post-implant. Survival from lead-related complications improved to a clinically acceptable rate in the cohort of patients when revised implant techniques were employed. CONCLUSIONS: With the use of recommended implant techniques, the study results support the electrical efficacy and safety of a catheter-delivered, lumenless lead in traditional or alternate right atrium or right ventricle sites through 18 months post-implant.
Sudden unexpected death caused by the failure of a cardiac valve prosthesis is a rare occurrence. A 45-year-old female suddenly died three years following mitral valve replacement for rheumatic mitral stenosis. At autopsy, death was determined to be due to a metallic fatigue of the mitral valve prosthesis.
PURPOSE OF THE STUDY: To compare femoral reconstruction using megaprosthesis versus allograft prosthesis composite. MATERIAL AND METHODS: Forty-one consecutive proximal femoral reconstructions with an allograft-prosthesis composite (21 cases) or a megaprosthesis (20 cases) after tumor resection were reviewed in a retrospective study. The following criteria were considered: functional outcome; long term survival; complications. Chi-square test and Wilcox tests were used to compare groups. The medium and long-term survival curves for these reconstructions were made using the Kaplan-Meier standard methods. The failure of prosthesis was defined as revision for mechanical failure (either aseptic loosening or dislocation), for infection or local recurrence. The comparison of the curves was performed using the Log-Rank test. RESULTS: Infection (10 p. 100) and instability, in both groups, and loosening, in the megaprosthesis group, were the common causes of failure. There was difference between functional results in the two groups (limping and crutches using was more lower in allograft-prosthesis composite group). Survival analysis showed a 5 and 10-year survival of 77 +/- 12 p. 100 for the patients with composites. Five and ten - year survival were 73 +/- 11 p. 100 and 0 p 100 respectevely for those with megaprostheses. No significant difference was noted between survival of these two groups but a tendancy (p =0.09). Radiological allograft resorption was noted for more than 50 p. 100 of allograft composite prosthesis without modification of functional result or symptomatic loosening. DISCUSSION: The functional results seem better in the composite group when compared to the megaprosthesis group. Reconstruction of the abductor mechanism is essential to stabilize the prosthesis and to decrease the limp. When the great trochanter cannot be preserved, we used suture of gluteus medius tendon to tensor of fascia lata, which is re-enforced using a piece of biceps femoris. The dislocation rate was approximately the same in our two groups. Several authors reported a lower dislocation rate with composite reconstructions than massive prosthesis. The rate of infection is similar to other reported series. In our study it has been possible to show a tendancy for superior survival of the composite reconstruction. When the review was later than 5 years the radiological appearance of the graft in our series was often concerning with resorption or fragmentation present in six of the eight cases. This radiological appearance is not as yet responsible for any revision or any change in the functional result however it does remain a worry. CONCLUSION: Composite reconstructions probably allow a better functional result when considering proximal reconstruction of the femur. The radiological appearance of these allografts in the long term is however worry some without any evidence so far of worsening functional level or any evidence of prosthetic loosening. It would seem to us that the current level of knowledge would advocate the use of massive allografts together with prosthesis. This does seem still to remain the best choice for proximal femoral reconstruction.
Explore the source record for details and available documents.
A 31-year-old woman developed increasing signs of congestive heart failure 15 years following placement of a mitral Starr-Edwards mechanical valve. A preoperative transesophageal echocardiogram (TEE) demonstrated a large, obstructive valvular thrombus and the patient underwent successful reoperative valve replacement.