Biomedical subjects

H J Wilke

Publications and source records attributed to H J Wilke.

At least 19 recordsLinked to original sources

PubMed2003

Irinotecan is active in chemonaive patients with metastatic gastric cancer: a phase II multicentric trial.

To assess the response rate and the tolerance of irinotecan as first-line therapy, 40 patients with metastatic gastric cancer received irinotecan 350 mg m(-2) every 3 weeks administered as a 30 min infusion. Among the 35 patients evaluable for response, two complete and five partial responses were recorded (response rate: 20.0% (95% CI:8.4-36.9%)). In total, 16 patients achieved stable disease and 12 progressive disease. In all, 66 percent of the patients benefited from tumour growth control. The median time to progression was 3.0 months (95% CI: 2.3-4.4%). The median overall survival was 7.1 months (95% CI: 5.2-9.0%). The probability of being alive at 6 months and 9 months was 61.0 and 32.4%, respectively. The median number of cycles per patient was 3 (range 1-14), and the relative dose intensity was 0.98. The most common grade 3-4 toxicities by patients were diarrhoea 20%, asthenia 10%, nausea 7.5%, vomiting 5.0%, abdominal pain 5%, neutropenia 38.5%, leucopenia 28.2%, anaemia 12.8% and thrombocytopenia 5.1%. Febrile neutropenia occurred in 12.5% of patients. These findings indicate that irinotecan is active and well tolerated in patients with metastatic gastric adenocarcinoma and warrants further evaluation in this clinical setting.

Adenocarcinoma↗

PubMed2003

Capecitabine and irinotecan as first-line chemotherapy in patients with metastatic colorectal cancer: results of an extended phase I study.

BACKGROUND: To define the maximum-tolerated dose (MTD) and to evaluate the dose-limiting toxicities (DLTs) of the combination of capecitabine and irinotecan in patients with metastatic colorectal cancer. PATIENTS AND METHODS: Thirty-seven patients with measurable metastatic colorectal cancer with no prior chemotherapy for metastatic disease were treated at three dose levels (DLs). For the first two dose levels, irinotecan (70 mg/m(2)) was administered once a week for 6 weeks in combination with 2 weeks of capecitabine at 1000 mg/m(2) (DL1) or 1250 mg/m(2) (DL2) twice daily, starting on days 1 and 22. In the last dose escalation step, the dose of irinotecan was increased to 80 mg/m(2) (DL3). One cycle lasted 7 weeks. RESULTS: In the subsequent phase I trial, 96 cycles of capecitabine and irinotecan were administered. At DL3, three out of six patients experienced DLTs (diarrhea, neutropenia, asthenia). In order to confirm the safety of the recommended dose, DL2 was extended to 15 patients. Five patients (33%) showed DLTs at this dose level, which was considered too high to embark on further clinical studies. Subsequently, the starting dose (DL1) was extended to a total of 16 patients, with diarrhea being the main toxicity. The overall response rate was 38% [95% confidence interval (CI) 21% to 58%], with a median response duration of 8.7 months (95% CI 6.4-11.5 months). CONCLUSIONS: The recommended doses for further studies are irinotecan 70 mg/m(2) and capecitabine 1000 mg/m(2). The combination of capecitabine and irinotecan appears to have significant therapeutic efficacy with manageable toxicity.

Adult↗

PubMed2003

Dynamic stabilization of the lumbar spine and its effects on adjacent segments: an in vitro experiment.

In recent years, nonfusion stabilization of the lumbar spine has gained more and more popularity. These nonfusion systems intend to maintain or restore the intersegmental motions to magnitudes of the intact spine and have no negative effects on the segments adjacent to the stabilized one. This study investigated the DYNESYS, a dynamic nonfusion system, which is designed to stabilize the bridged segments while maintaining the disc and the facet joints. To determine the magnitude of stabilization and the effect of the stabilization on the adjacent segment, six lumbar cadaver spines were fixed in a spine tester and loaded with pure moments in the three main motion planes. For each spine, four different stages were tested: intact, defect of the middle segment, fixation with the DYNESYS, and fixation with the internal fixator. Intersegmental motions were measured at all levels. For the bridged segment, the DYNESYS stabilized the spine and was more flexible than the internal fixator. This difference between the internal fixator and the DYNESYS was most pronounced in extension (P < 0.05), with the DYNESYS restoring the motion back to the level of the intact spine. The motion in the adjacent segments was not influenced by either stabilization method. Our results suggest that the DYNESYS provides substantial stability in case of degenerative spinal pathologies and can therefore be considered as an alternative method to fusion surgery in these indications while the motion segment is preserved.

Adult↗

PubMed2002

[Neon--a new angle-stable implant system for dorsal occipitocervical instrumentation. Biomechanical comparison with established systems].

Posterior instrumentation of the occipitocervical spine is well-established for different indications. The aim of this study was to evaluate whether posterior internal fixation of the occipitocervical spine with the new implant system improves primary biomechanical stability. Primary stability was significantly increased in all load cases with the new modular implant system compared to the other implant systems. Pedicle screw instrumentation tended to be stabler compared to lateral mass screws; nevertheless, significant differences could be observed only for lateral bending. As the experimental design precluded any cyclic testing, the data represent only the primary stability of the implants. In summary, this study showed that posterior instrumentation of the cervical spine using the new neon occipito-cervical system improves primary biomechanical stability compared to the CerviFix system and the Olerud cervical rod spinal system.

Aged↗

PubMed2002

[MAC-TL twin screw. A new thoracoscopic implantable stabilization system for treatment of vertebral fractures--implant design, implantation technique and in vitro testing].

Due to the lack of an appropriate instrumentation system for minimally invasive procedures to treat spinal fracture, a new thoracoscopically implantable stabilization system was developed. This report describes the new implant design and implantation technique. In a biomechanical in vitro study, an anterior corpectomy model representing the worst case of burst fracture instability was simulated, and the primary stability parameters of the new system were evaluated in comparison to a dorsal stabilization system. With the interbody graft and fixation, the new system demonstrated higher stabilizing effects in flexion/extension and lateral bending and restored axial stability beyond the intact spine and the dorsal stabilization system. Considering all the advantages of the endoscopic procedure and this biomechanical characterization, the clinical trial is warranted; its usefulness has been demonstrated in more than 150 cases in a multicenter study to date.

Aged↗

PubMed2002

[MACS-TL polyaxial screw XL. A new concept for increasing stability of ventral spondylodesis in the presence of dorsal injuries].

The influence of additional dorsal structure damage on anterior stabilization of thoracolumbar fracture is still unknown. Screw cement enhancement is a possibility to reinforce the stability of anterior instrumentation. A new anchorage system has been developed for fixation of anterior stabilization devices, adapted through geometric optimization and the possibility of optional additional cementation after screw insertion in cases of poor bone quality. Is this enhancement strong enough to support a single anterior procedure such as the thoracoscopic technique and still compensate for dorsal instability? A biomechanical in vitro study simulating an anterior corpectomy, strut grafting, and overbridging stabilization with a dorsal laminectomy as dorsal structure damage was performed, and the primary stability parameters were evaluated with and without screw cement enhancement. The additional cementation enhanced the primary stability of the anterior instrumentation and compensated for dorsal instability.

Aged↗

PubMed2002

[Effect of artificial disk nucleus implant on mobility and intervertebral disk high of an L4/5 segment after nucleotomy].

This study investigated whether after a nucleotomy and implantation of a prosthetic disk nucleus (PDN) the original height and mobility of an L4/L5 disk can be restored. Compared to the intact state (100%), nucleotomy increased the median values of the normalized range of motion (ROM) in flexion/extension to 118%, lateral bending to 112%, and axial rotation to 121%. PDN implantation reduced ROM to 102%, 88%, and 90%. These differences were even more distinct when comparing the neutral zone (NZ) with 210%, 173%, and 107% after nucleotomy and 146%, 149%, and 44% after PDN implantation. With an axial preload of 200 N, disk height after nucleotomy was reduced by about 1.3 mm and could be restored with PDN implantation. PDN implantation can restore disk height and ROM after nucleotomy to normal values and reduce the strong NZ increase. Further biomechanical characterization of this therapy with PDN is necessary.

Adult↗

PubMed2002

[Stabilizing effect and sintering tendency of 3 different cages and bone cement for fusion of cervical vertebrae segments].

Important requirement for spinal fusion devices for segment are that they provide sufficient stability and guarantee a low subsidence risk. An important requirement for spinal fusion devices for segments are that they provide sufficient stability and guarantee a low subsidence risk. Therefore, in the following in vitro study, the stabilizing effect and subsidence tendency of cervical fusion cages and bone cement were investigated during cyclic loading. The WING cages (Medinorm AG) and BAK cages (Spinetec) made of titanium, the carbon fiber reinforced PEEK cage from Acromed (DePuy Acromed), and bone cement (PMMA, Sulzer) were tested. Twenty-four human cervical spine specimens were first tested intact with a standardized flexibility test (+/- 2.5 Nm). Then the implants were inserted and the primary stability determined. For the simulation of the postoperative loading of the cervical spine a cyclic loading protocol with 700 loading cycles was performed. In this test pure moments +/- 2.0 Nm in 9 different loading directions in randomized order were applied together with a 50 N preload to simulate the weight of the head. The subsidence and "long term stability" was measured after 50, 100, 200, 300, 500, and 700 cycles. All implants had a stabilizing effect in all directions most obviously in lateral bending. Here the range of motion was between 20.9% (AcroMed Cage), and 62% (BAK Cage) with respect to the intact specimen (100%). In laterial bending, flexion, and axial rotation the AcroMed cage stabilized the most followed by the bone cement, WING and BAK Cage. In extension the specimens treated with bone cement were the most stable. After 700 loading cycles the specimens with the BAK cage lost 1.6 mm in height, with the WING Cage 0.8 mm, with the Acromed 0.7 mm, and with the bone cement 0.5 mm. Two Acromed Cages dislocated during the long term testing. Cages have the potential to stabilize as effectively as bone cement. A smaller contact area, however, causes a higher subsidence risk compared to bone cement but increases the fusion area, thus increasing the chance of obtaining bony fusion.

Biomechanical Phenomena↗

PubMed2002

[Dislocation tendency, stabilizing effect and sintering tendency of different lumbar vertebrae cages in an in vitro experiment].

For biomechanical purposes, interbody fusion cages should not dislocate, should provide high stability, and should have a low subsidence risk. Zientek (Marquardt Medzintechnik), Stryker (Stryker Implants), and Ray lumbar interbody fusion cages (Surgical Dynamics) were tested in this study. They were implanted by pairs from a posterior approach without further stabilization. In a first step, each cage design was implanted into four human L3-4 segments and extracted posteriorly under an axial preload of 200 N. In a second step, standard flexibility tests were carried out with 24 human L2-3 and L4-5 specimens in an intact condition, directly after cage implantation, and after cyclic axial compression loading (200-1000 N, 40,000 cycles, 5 Hz). In a third step, a destructive axial compression test was carried out. Maximum pullout force was highest with Ray cages (median 945 N), followed by Zientek (605 N) and Stryker cages (130 N). With all three cage designs, primary stability was higher in lateral bending and flexion than in extension and axial rotation. Implantation of Ray cages caused a decreased range of motion in all three loading directions ranging between 49% and 99%. Zientek cages only stabilized in lateral bending, flexion, and extension (45-78%) and Stryker cages in none of the three loading directions. Cyclic loading caused an increased range of motion in all cases up to 190%. Axial compression force at failure was 8413 N with Ray cages, 8359 N with Stryker cages, and 5486 N with Zientek cages. The cage design seems to influence the dislocation tendency. In this regard, threaded cages or cages with anchorage systems seem to provide more security. The stabilizing effect seems to be mainly influenced by factors such as the degree of distraction or destruction of the facet joints rather than by the cage design.

Adult↗

PubMed2002

[Spinal load bearing during sitting in an office chair with a tilting back].

Long periods of quiet sitting is considered a cause of low back pain. It is often assumed that spinal loads are high, especially when sitting erect. Modern office chairs with a tiltable back permit changes in the seated posture. In the most reclined position, some new chairs even match a kyphotic form of the lumbar spine. It is assumed that sitting on such a chair reduces low back pain. With the aim of determining spinal loading in different sitting positions, the loads acting on implanted fixation devices were measured telemetrically in two patients. Loads were measured in patients sitting on six different chairs with tiltable backs. In modern chairs, implant loading was always lower than while walking. In the end-tilt position of the chairback, loads were always lower than when the chairback was upright. Even when the lordotic curvature of the lumbar spine was "corrected", loads on the fixator were lower than when the subject was seated in the upright position. In a modern chair, spinal loading is no higher than with non-adjustable office chairs.

Biomechanical Phenomena↗

PubMed2001

Influence of a follower load on intradiscal pressure and intersegmental rotation of the lumbar spine.

STUDY DESIGN: Intradiscal pressure and intersegmental rotation of human lumbar spines were measured in vitro. OBJECTIVES: To determine the effect of a follower load on mechanical behavior at all levels of the lumbar spine. SUMMARY OF BACKGROUND DATA: Different loads have been proposed for studying the mechanical behavior of the lumbar spine. The influence of a follower load on intradiscal pressure at the different levels is unknown. METHODS: Ten human cadaveric lumbar spines were loaded in the three main anatomic planes with pure moments of 3.75, 7.5, and 7.5 Nm plus a follower load of 280 N. Intradiscal pressure and intersegmental rotation were measured at all levels. RESULTS: An additional follower load increased the intradiscal pressure, slightly reduced the intersegmental rotation for axial rotation, and hardly affected intersegmental rotation for lateral bending and flexion-extension. CONCLUSIONS: A superimposed follower load renders spinal loading with pure moments more physiologic.

Adult↗

PubMed2001

Comparison of intradiscal pressures and spinal fixator loads for different body positions and exercises.

Loading of the spine is still not well understood. The most reliable results seemed to come from the intradiscal pressure measurements from studies by Nachemson, 1966. A new similar study by Wilke et al. (1999) complemented the present study and confirmed some of the earlier data, although it contradicted others. The new data did not confirm that the load on the spine is higher in sitting compared with standing and did not find distinct differences between positions in which subjects were lying down. The objective of this paper was to compare results from two independent in vivo studies (applying different methods) to provide information about spinal loading. In one of these studies (Wilke 1999), intradiscal pressure was measured in one volunteer in different postures and exercises, and in the other study (Rohlmann et al. 1994) the loads on an internal spinal fixation device (an implant for stabilising unstable spines) were determined in 10 patients. The absolute values of the results from both studies were normalized and compared for many body positions and dynamic exercises. The relative differences in intradiscal pressure and flexion bending moments in the fixators corresponded in most cases. Both studies showed slightly lower loads for sitting than for standing and comparatively low loads in all lying positions. High loads were measured for jogging, jumping on a trampoline and skipping. Differences between trends for intradiscal pressure and for flexion bending moments in the fixators were found when the load was predominantly carried by the anterior spinal column, as during flexion of the upper part of the body or when lifting and carrying weights. The combination of the results from these two methods may improve the understanding of the biomechanical behaviour of the lumbar spine and may be used to validate models and theories of spinal loading.

Aged↗

PubMed2001

Is it possible to simulate physiologic loading conditions by applying pure moments? A comparison of in vivo and in vitro load components in an internal fixator.

STUDY DESIGN: Loads acting in an internal fixator measured in vitro under the application of pure moments such as those commonly used for implant testing and basic research were compared with loads measured in 10 patients in vivo. OBJECTIVES: To investigate whether these recommended loading conditions are valid by comparing in vivo measurements and those obtained in an in vitro experiment. SUMMARY OF BACKGROUND DATA: Pure bending moments are often preferred as loading conditions for spinal in vitro testing, either for implant testing or basic research. The advantage of this loading pattern is that the bending moment is uniform along the multisegmental specimen. However, functional loading of the spine by muscles or external loads subjects the spine to a combination of forces and moments. METHODS: In an in vivo experiment, loads acting on an internal spinal fixator in 10 patients were determined before and after anterior interbody fusion during flexion, extension, left and right lateral bending, and left and right axial twisting of the upper body with the patient standing. For comparison, an equivalent in vitro data set was created with 7 human lumbar specimens in which the same type of fixator was used. All specimens were tested under the application of pure bending moments in the three main motion planes in the intact state with fixator, after corpectomy, and with bone graft. RESULTS: Consistent qualitative agreement between in vivo and in vitro measurements for the loads acting in the internal spinal fixator were found for axial rotation and lateral bending. For flexion and extension, reasonable agreement was found only for the intact spines with fixators. After corpectomy and after inserting a bone graft, the median values for axial force and bending moment in the sagittal plane in vitro did not agree with in vivo measurements. An axial preload in the in vitro experiment slightly increased the axial compression force and flexion bending moment in the fixators. CONCLUSIONS: The application of pure moments to intact lumbar spinal specimens in vitro produces forces and moments in implants comparable with loads observed in vivo. During basic research on intact specimens or implant testing involving a removed disc or corpectomy, muscle forces are necessary to simulate realistic conditions.

Humans↗

PubMed2001

Bedside percutaneous tracheostomy: clinical comparison of Griggs and Fantoni techniques.

Elective tracheostomy is widely considered the preferred airway management of patients on long-term ventilation. In addition to open tracheostomy, a number of percutaneous procedures have been introduced during the last two decades, among them techniques according to Griggs (guidewire dilating forceps, or GWDF) and to Fantoni (translaryngeal tracheostomy, or TLT). The aim of the study was to evaluate these two techniques in terms of perioperative complications, risks, and benefits in critically ill patients. A series of 100 critically ill adult patients on long-term ventilation underwent elective percutaneous tracheostomy, either according to the Griggs (n = 50) or Fantoni (n = 50) technique. Tracheostomy was performed under general anesthesia at the patient's bedside. The mean (+/-SD) operating times were short, 9.2 +/- 3.9 minutes (TLT) and 4.8 +/- 3.7 minutes (GWDF) on average. Perioperative complications were noted in 4% of patients during either TLT or GWDF and included massive bleeding, mediastinal emphysema, posterior tracheal wall injury, and pretracheal placement of the tracheostomy tube. With regard to oxygenation, pre- and postoperative arterial oxygen tension divided by the fraction of inspired oxygen (PaO2/FiO2) ratios did not vary significantly, and no perioperative hypoxia was noted regardless of the technique used. We conclude that both TLT and GWDF represent attractive, safe alternatives to conventional tracheostomy or other percutaneous procedures if carefully performed by experienced physicians and under bronchoscopic control.

Adolescent↗

PubMed2001

Effect of an internal fixator and a bone graft on intersegmental spinal motion and intradiscal pressure in the adjacent regions.

Stabilizing a lumbar spine with an implant alters the mechanical properties of the bridged region. In order to determine whether this procedure is associated with higher loads in the adjacent segments, seven lumbar cadaver spines were mounted in a spine tester and loaded with pure moments of flexion/extension, left and right lateral bending, and left and right axial rotation. The material studied comprised intact lumbar spines, intact spines with bisegmental internal spinal fixators, and postcorpectomy spines both with a graft and fixators and with fixators alone. Intradiscal pressures and intersegmental motion were measured at all levels. In the bridged region, these parameters were strongly affected by an internal fixator. In most cases, the effect was small in the regions above and below the fixators. Highly significant differences in these regions (P<0.01) were far below the interspecimen range. We did not find any case where both intradiscal pressure changes and intersegmental motion showed highly significantly differences in the regions adjacent to the bridged one. Our results suggest that disc degeneration, which is sometimes found at the level directly above and below the fixators, is not caused by mechanical factors.

Adult↗

PubMed2001

Resistance of the lumbar spine against axial compression forces after implantation of three different posterior lumbar interbody cages.

BACKGROUND: The aim of using interbody fusion cages is to distract the degeneratively decreased disc height to decompress the neural structures in the intervertebral foramina and allow bony fusion. Prerequisite for a successful fusion therapy is a high resistance against subsidence and breakage. METHOD: Three types of implants, a cylindrical threaded titanium cage (Ray) (1c), a bullet shaped PEEK cage (Stryker) (1a) and a rectangular titanium cage with an endplate anchorage device (Marquardt) (1b) were implanted in eight monosegmental lumbar spine specimens (L 2/3 and L 4/5). Each specimen underwent a cyclic loading test with 40000 cycles at a rate of 5 Hz. A cyclic axial compression force ranging from 200 Newton [N] to 1000 N was applied and the axial translation recorded simultaneously to determine the subsidence tendency. After this procedure the specimens were tested with a progressive axial force until breakage. FINDINGS: There were only small differences in the subsidence tendency for the three cage designs. The height reduction due to cyclic loading ranged between 0.9 mm (Marquardt), 1.2 mm (Stryker) and 1.4 mm (Ray). The median break force ranged from 5486 N (Marquardt), 8359 N (Stryker) to 8413 N (Ray). No correlation between bone mineral density and failure load could be detected. INTERPRETATION: Endplate preparation and cage design of the tested implants do not seem to influence the resistance of the segment against cyclic axial compression. The compression with a continuously increasing load revealed that an implant-bone failure is not to be expected in physiological limits for all three cage types.

Biomechanical Phenomena↗

PubMed2001

Combined anteroposterior spinal fixation provides superior stabilisation to a single anterior or posterior procedure.

Fusion is the main goal in the surgical management of the injured and unstable spine. A wide variety of implants is available to enhance this. Our study was performed to evaluate the stabilising characteristics of several anterior, posterior and combined systems of fixation. Six thoracolumbar (T11 to L2) spines from 13-week-old calves were first tested intact. Then the vertebral body of T13 was removed and the defect replaced and supported by a wooden block to simulate bone grafting. Dorsal implants consisting of a Universal Spine System (USS) fracture system and an AO Fixateur interne (AOFI), and ventral implants comprising of a Kaneda Classic, a Kaneda SR, a prototype of the VentroFix single clamp/single rod construct (SC/SR) and the VentroFix single clamp/double rod construct (SC/DR) were first implanted individually to stabilise the removal of the vertebral body. Simulating the combined anteroposterior stabilisations, all ventral implants were combined with the AOFI. The range of motion (ROM) was measured under loads of up to 7.5 Nm. The load was applied in a custom-made spine tester in the three primary directions while measuring the intervertebral movements using a goniometric linkage system. The dorsal systems limited ROM in flexion below 0.9 degrees and in extension between 3.3 degrees and 3.6 degrees (median values). The improved Kaneda System SR yielded a mean ROM of 1.8 degrees in flexion and in extension. The median rotation found with the VentroFix (SC/DR) was 3.2 degrees for flexion and 2.8 degrees for extension. Reinforcement of the ventral constructs with a dorsal system reduced the ROM in flexion and extension in all cases to 0.4 degrees and lower. In rotation, the median ROM of the anterior systems ranged from 2.7 degrees to 5.1 degrees and for the posterior systems from 3.9 degrees to 5.7 degrees, while the combinations provided a ROM of 1.2 degrees to 1.9 degrees. In lateral bending, the posterior implants restricted movement to 1.1 degrees, whereas the anterior implants allowed up to 5.2 degrees. The combined systems provided the highest stability at less than 0.6 degrees. Our study revealed distinct differences between posterior and anterior approaches in all primary directions. Also, different stabilisation characteristics were found within the anterior and posterior groups. Combinations of these two approaches provided the highest stability in all directions.

Animals↗

PubMed2001

Occupational exposure to volatile anaesthetics: epidemiology and approaches to reducing the problem.

Long term occupational exposure to trace concentrations of volatile anaesthetics is thought to have adverse effects on the health of exposed personnel. In contrast with halothane--an agent likely to cause mutagenic effects and proven to be teratogenic--isoflurane and enflurane have not so far been proved to have adverse effects on the health of personnel exposed long term. Data on the newer agents sevoflurane and desflurane are limited. Since possible health hazards from long term exposure to inhalational anaesthetics cannot yet be definitively excluded, many Western countries have established limits for exposure. These usually range from 2 to 10 ppm as a time-weighted average over the time of exposure. A number of investigations have demonstrated that, in operating theatres with modern climate control and waste anaesthetic gas scavenging systems, occupational exposure is unlikely to exceed threshold limits. However, occupational exposure from the use of volatile agents in operating theatres with poor air control--especially during bronchoscopy procedures in paediatric patients--remains a source of concern. This also holds true for both postanaesthesia care units (PACU) and intensive care units (ICU) lacking proper air conditioning and waste gas scavengers. To minimise occupational exposure to volatile anaesthetics, all measures must be taken to provide climate control and properly working scavenging devices, and ensure sufficient personal skill of the anaesthetist, e.g. during inhalational mask induction. Furthermore, low-flow anaesthesia should be used whenever possible. The sole use of intravenous drugs such as propofol instead of volatile agents, were this possible, would eliminate occupational exposure, but may result in environmental pollution by toxic metabolites (e.g. phenol).

Anesthetics, Inhalation↗