Models in fracture healing: report from the Reisensburg workshop September 1999.
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Biomedical subjects
Publications and source records attributed to L Claes.
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In this study, the three-dimensional stabilizing capabilities of the AO-Internal Fixator (IF) and the new Universal Spine System (USS) were investigated. Both devices were tested without and with the cross-link system (IF, IFC, USS, USSC). To determine biomechanical characteristics, a human thoracolumbar spine instability model with resection of the vertebral body Th12 was created. The vertebral body was replaced by a spacer and transpedicular posterior stabilization was performed from Th11 to L1. All devices reduced the range of motion (ROM) significantly compared to the values of the intact specimen. In flexion the IFC showed the highest reduction of ROM (85% of intact), followed by the USSC, USS and IF (79% of intact). In extension the ROM was restored again most by the IFC (52% of intact), followed by the USSC, IF and USS (44% of intact). In lateral bending stability was provided by the USSC (right 78% and left 81% of intact), followed in right lateral bending by the IF, IFC and USS and in left lateral bending by the USS, IF and IFC. In axial rotation the ROM was reduced primary by the IFC (right 51% and left 46% of intact), followed in right axial rotation by the USS, USSC and IF, in left axial rotation by the USSC, USS and IF. Additional stability by crosslinking has been provided in the IF and the USS in flexion and extension, in the USS in lateral bending and in the IF in axial rotation nonsignificantly. The neutral zone (NZ) was reduced by posterior instrumentation in flexion/extension and right/left lateral bending significantly. In axial rotation only the USSC decreased the NZ below intact levels. The study showed no statistical significant differences in the stabilizing capabilities of the USS compared to the IF. For both implants the cross-link system increased stability in the chosen instability model insignificantly only.
OBJECT: The function of interbody fusion cages is to stabilize spinal segments primarily by distracting them as well as by allowing bone ingrowth and fusion. An important condition for efficient formation of bone tissue is achieving adequate spinal stability. However, the initial stability may be reduced due to repeated movements of the spine during everyday activity. Therefore, in addition to immediate stability, stability after cyclic loading is of remarkable relevance; however, this has not yet been investigated. The object of this study was to investigate the immediate stabilizing effect of three different posterior lumbar interbody fusion cages and to clarify the effect of cyclic loading on the stabilization. METHODS: Before and directly after implantation of a Zientek, Stryker, or Ray posterior lumbar interbody fusion cage, 24 lumbar spine segment specimens were each evaluated in a spine tester. Pure lateral bending, flexion-extension, and axial rotation moments (+/- 7.5 Nm) were applied continuously. The motion in each specimen was measured simultaneously. The specimens were then loaded cyclically (40,000 cycles, 5 Hz) with an axial compression force ranging from 200 to 1000 N. Finally, they were tested once again in the spine tester. CONCLUSIONS: In general, a decrease of movement in all loading directions was noted after insertion of the Zientek and Ray cages and an increase of movement after implantation of a Stryker cage. In all three cage groups greater stability was demonstrated in lateral bending and flexion than in extension and axial rotation. Reduced stability during cyclic loading was observed in all three cage groups; however, loss of stability was most pronounced when the Ray cage was used.
The treatment of large bony defects by callus distraction is well accepted, but the duration of treatment is long and the rate of complications increases accordingly. We have examined the effect of the stiffness of the axial fixator on reducing the time for maturation of callus. We created a mid-diaphyseal defect of 15 mm in the metatarsal bone in sheep and stabilised it with a ring fixator. After four days a bony segment was transported for 16 days at 1 mm per day. After 64 days the animals were divided into four groups, three with axial interfragmentary movement (IFM) of 0.5, 1.2 and 3.0 mm, respectively, and a control group. The 3.0 mm IFM group had the smallest bone density (p = 0.001) and area of callus and the largest IFM after 12 weeks; it also had typical clinical signs of hypertrophic nonunion. The most rapid stiffening of the callus was in the 0.5 mm group which had the smallest IFM (p = 0.04) after 12 weeks and radiological signs of bridging of the defect. These results indicate that suitable dynamic axial stimulation can enhance maturation of distraction callus when the initial amplitude is small, but that a large IFM can lead to delayed union.
AIM OF THE STUDY: It has been well shown by human and animal studies that mechanical load is an important regulator of skeletal mass and architecture. However, cellular reactions which adapt bone tissue to the mechanical environment are not definitively determined. For this purpose we studied the cell activity of human bone derived cell cultures after mechanical stimulation by cyclic, uniaxial strain at a magnitude occurring in normal loaded bone tissue. MATERIALS AND METHODS: Human osteoblasts were isolated from cancellous bone biopsies of 5 different donors. Cell seeding was made in DMEM in a density of 10.000 cells/cm(2) on deformable culture dishes for three days prior to initiating cell stretching at 1000 microstrain, 1Hz for 1800 cycles for two subsequent days with an especially developed cell stretching device. 48h after the second stimulation cells were harvested and cell number was determined with a Coulter Counter. Cell bound alkaline phosphatase activity was analyzed in cell lysates by a colorimetric assay, osteocalcin and CICP (procollagen I propeptide) production were analyzed in cell supernatants with ELISAs. Three parallel cultures were tested. STATISTICS: Wilcoxon. RESULTS: In all experiments mechanical stimulation resulted in a significant increase in cell number (10-48%) and CICP release (7-49%). Simultaneously a significant decrease in alkaline phosphatase activity (9-25%) and osteocalcin release (5-32%) could be observed. CONCLUSIONS: The results demonstrate that cyclic strain at physiologic magnitude leads to an increase of early osteoblast activities related to matrix production while those activities which are characteristic for the differentiated osteoblast and relevant for matrix mineralization are decreased. These new findings confirm in vivo observations about the importance of dynamic strain for bone formation during fracture healing and bone remodeling and could contribute to the optimization of fracture healing.
STUDY DESIGN: The primary biomechanical stability of anterior internal fixation of the cervical spine obtained with a new monocortical expansion screw in vitro was evaluated. OBJECTIVES: To determine whether the anterior internal fixation of the spine obtained with the new monocortical expansion screw provides biomechanical stability comparable with that obtained with bicortical fixation. SUMMARY OF BACKGROUND DATA: The anterior plate instrumentation used with bicortical screw fixation in the cervical spine provides a primary stability superior to that associated with monocortical screw fixation. However, bicortical screws have the potential to perforate the posterior cortex. Therefore, monocortical instrumentation systems were developed, but without the biomechanical stability associated with bicortical systems. A new expansion screw for monocortical fixation was developed to improve biomechanical stability of monocortical systems. METHODS: Three different internal fixation systems were compared in this study: 1) H-plate with AO 3.5-mm bicortical screws, 2) cervical spine locking plate with monocortical screws, and 3) H-plate with the new monocortical expansion screws. Eight fresh human cadaver spine segments from C4 to C7 were tested in flexion-extension, axial rotation, and lateral bending using pure moments of +/- 2.5 Nm without axial preload. Five conditions were investigated consecutively: 1) intact spine; 2) uninstrumented spine with the segment C5-C6 destabilized; 3-5) instrumentation of the segment C5-C6 with the three implants mentioned above after removal of the disc and insertion of an interbody spacer. RESULTS: Between bicortical and monocortical expansion screw H-plate fixation, no significant differences were observed in all load cases concerning range of motion and neutral zone. The neutral zone and range of motion were significantly larger for the cervical spine locking plate than for bicortical and monocortical expansion screw fixation in all load cases, except neutral zone for axial rotation versus bicortical screw fixation. The instrumented cases only had a significantly lower range of motion and neutral zone than the intact cases in extension-flexion, whereas for lateral bending and axial rotation no significant differences could be observed. Because the experimental design precluded any cyclic testing, the data represent only the primary stability of the implants. CONCLUSIONS: In anterior instrumentation of the cervical spine using a H-plate, the new monocortical expansion screw provides the same biomechanical stability as the bicortical 3.5-mm AO screw and a significantly better biomechanical stability than the cervical spine locking plate. Therefore, the expansion screw may be an alternative to the bicortical fixation and does not involve the risk of penetration of the posterior vertebral body cortex.
Anterior intervention of metastatic lesions of the spine can accomplish relief of pain, spinal decompression, and restoration of spinal stability. Ventral vertebral body replacements have been developed to provide these conditions but there have been problems with loosening at the implant-bone interface, mechanical failure, and X-ray artifacts from the metal. Intraoperative stability of the vertebral body replacement is especially critical to avoid loosening of the implant and to achieve long-term bony incorporation. This study compared the biomechanical performance in vitro of a new radiolucent system for vertebral body replacement to three currently marketed systems. The new system features a composite bioglass-polyurethane body and a new configuration of polymeric fastening hardware. Range of motion, neutral zone, and several interfacial motion parameters were measured under pure moments of 3.75 Nm in the three anatomical directions. The new system provided the significantly highest restraint of motion for all parameters. Mechanically, the new system is preferable at least initially to a sampling of systems representative of those currently used.
Cells like fibroblasts and osteoblasts are oriented by different extracellular guiding signals like an electric field, a bent surface, and a periodically stretched surface. An automatic controller is responsible for the cell alignment. The controller contains both a deterministic and a stochastic signal. The following machine properties were determined: (1) The angle dependence of the cellular signal transformer is cos 2(psi 0 - psi). (2) The set point of the automatic controller is psi 0 = +/- 90 degrees. The cells like to orient their long axis perpendicular to the direction of the applied guiding signal. (3) The signal transformer measures the extracellular signal in a quadratic fashion. The cells cannot register the sign of the guiding field. (4) The stochastic signal in the automatic controller can be quantified by a characteristic time (approximately 130 min for fibroblasts). (5) The extracellular signal is registered in cell-made standards (ratio of the deterministic and stochastic signal equals one): 0.3 +/- 0.05 V/mm for human fibroblasts (electric field) and 85 +/- 3 microns for human fibroblasts and osteoblasts (cyclindrically bent surface). (6) The lag-time in the signal transduction system of fibroblasts is approximately 4 min.
Nowadays scientific publishing in peer reviewed international accepted journals is not easy. Rejection rates up to 75% occur. The aim of this paper is to provide guidance in the preparation of journal papers for the inexperienced scientific writer. The traditional paragraphs Abstract, Introduction, Material and Methods, Results, and Discussion are described with respect to its contents and basic message and how these sections are designed to build a logical flow. Approved suggestions for the structural outline of each paragraph are made. The significance of reference list, figures, and tables is also explained. The review of a manuscript is discussed and the criterias for acceptance of a journal paper are indicated.
Posttraumatic malalignments are a frequent sequlae of IM nailing of lower extremity fractures. Conventional US has proven to be inferior to CT determinations of tibial or femural length and torsion. A new 3-D US method is presented that allows for accurate single step determination of lower extremity length and torsion without ionizing radiation. A regular US machine with a 5 Mhz linear probe is combined with an US localizer. Reference markers affixed to the lower extremity eliminate errors associated with patient position or motion. The 3-D US method was compared against CT (Ulm's method) in the measurement of torsion and length of the tibia and femur in 50 adults and 50 children. In both methods, the maximum difference of the intraindividual torsional angles and length measurements was 7 degrees and 7 mm. The maximum standard deviation for reproducibility in length measurement was 1.6 mm and 1.5 degrees for angular torsion. The new 3-D US technique was superior to CT in terms of reliability and reproducibility. Clinical advantages of the 3-D US technique include rapidity, independence from patient motion or positioning and the avoidance of ionizing radiation. Indications for 3-D torsional and length determinations include follow-up evaluation of adult and pediatric tibial and femoral fractures, pediatric limb and gait evaluations, and osteotomy planning.
The Kluger internal fixator, with its artificial fulcrum outside the operative site, had to be extended for multisegmental use. Three different prototypes, called Central Bar (CB), Double Bar I (DB I) and Double Bar II (DB II) were designed, which were fully compatible with the existing reduction system. To evaluate the ability of these newly developed systems to provide primary stability in a destabilized spine, their stiffness characteristics and stabilizing effects were investigated in multidirectional biomechanical stability tests and compared with those of the clinically well-known Cotrel-Dubousset (CD) system. The investigations were performed on a spine tester using freshly prepared calf spines. The model tested was that of an intact straight spine followed by a defined three-column lesion simulating the most destabilizing type of injury. Pure moments of up to 7.5 Nm were continuously applied to the top of each specimen in flexion/extension, left/right axial rotation, and left/right lateral bending. Segmental motion was measured using a three-dimensional goniometric linkage system. Range of motion and stiffness within the neutral zone were calculated from obtained load-displacement curves. The DB II attained 112.5% (P = 0.26) of the absolute stiffness of the CD system in flexion and enhanced its stability in extension by up to 144.3% (P = 0.004). In axial rotation of the completely destabilized spine, this system achieved 183.3% of the stiffness of the CD system (P < 0.001), and in lateral bending no motion was measured in the most injured specimens stabilized by the DB II. The DB I, which was the first to be designed and was considered to provide high biomechanical stability, did not attain the stiffness standard set by the CD system in either flexion/extension or axial rotation of the most injured spine. The study confirms that it is worthwhile to evaluate in vitro the biomechanical properties of a newly developed implant before its use in patients, in order to refine weak construction points and help to reduce device-related complications and to better evaluate its efficacy in stabilizing the spine.
The purpose of this combined study was to evaluate the stability and safety of a new monocortical screw-plate system for anterior cervical fusion and plating (ACFP) according to Caspar in comparison with classical bicortical fixation. In the biomechanical part of the study two groups, each comprising six fresh human cadaveric spines (C4-C7), matched for bone mineral density, additionally resulting in almost the same mean age, were used. Range of motion and neutral zone were analyzed in flexion-extension, rotation (left, right) and lateral bending (left, right) using pure moments of +/- 2.5 Nm for each specimen in the intact state, after discectomy at C5/6 and after discectomy at C 5/6 followed by bone grafting plus plating (Caspar plates), with either monocortical or bicortical screws. For all three motion planes, no significant difference could be found between the new monocortical and the bicortical fixation techniques. The clinical part of the study was performed as a prospective study on 30 patients suffering from symptomatic degenerative cervical disc disease in one segment. At the latest follow-up, no hardware- or graft-related complications were seen in any of the patients. Following these findings monocortical screw fixation can be recommended for the majority of anterior cervical fusion and plating procedures in degenerative disease, making the procedure quicker, easier, and safer. Bicortical screw fixation still has specific indications for multilevel stabilization, poor bone quality (osteoporosis, rheumatoid disease - as bicortical oversized rescue screw), unstable spines (trauma, tumour) and in particular for the realignment of kyphotic deformities (restoration of the normal lordotic curve). Due to the design of the study the results apply only to surgical treatment of monosegmental degenerative disc disease at the time.
Comminuted fractures most often are associated with compromised soft tissue conditions and diminished vascularization leading to a reduced osteogenesis. In contrast to stable fixation by compression plating with lag screws, the less stable but also less invasive techniques of external fixation, unreamed nailing, or bridging plates have become increasingly popular. The aim of this study was to compare the bone healing and osteogenesis of these fixation techniques. A triple wedge osteotomy of the sheep tibia was used as a bone healing model. Internal compression plate fixation of all fragments with lag screws was used in one group. In the other three groups, only the main proximal and distal fragments were fixed by external fixation, unreamed interlocking nail, or bridging plate. The sheep with compression plate fixation and lag screws showed the worst results after 12 weeks. The periosteal and endosteal osteogenesis and the apparent density of the newly formed bone in the fracture gaps were significantly lower than those seen in the sheep in the other three technique groups. The best results were found for the bridging plate and external fixator. From these results, it can be concluded that compression plate fixation should be avoided for treatment of comminuted fractures.
The present study investigated the effects of two different surgical procedures for the treatment of chronic ankle instability. Ten patients treated with an anatomic reconstruction using a periosteal flap were compared with a second group that received an Evans tenodesis. All patients were evaluated before and after surgery with clinical and radiographic examinations as well as dynamic pedobarography. Patient satisfaction and radiographic and functional results were comparable in both groups and revealed a good restoration of joint stability and gait symmetry. Our results indicate that both methods of ankle ligament reconstruction achieve a comparable clinical and functional outcome within 1 year after surgery.
To characterize the site-specific mechanical and histological properties in fracture repair and to relate these properties to the initial mechanical situation, an experimental fracture model was used in the metatarsus of 42 sheep. The mechanical situation of a transverse osteotomy was described by three gap sizes (1, 2, or 6 mm) and two amounts of strain (7 or 31%). An external fixator that allowed a defined axial movement provided control of these settings. Nine weeks following surgery, the healing area was dissected and tensile and compressive properties were measured in subregions of the fracture gap and the periosteal callus. The central, sagittal section was used for quantitative histology. We found the quality of the tissue along the osteotomy line to be most important for regaining mechanical stability. Increasing the size of osteotomy gaps resulted in poorer mechanical and histological qualities, and the repair process was less complete. Interfragmentary strain did not significantly influence the repair process. The smaller strain levels had already stimulated the secondary repair process, and this stimulatory effect could not be further enhanced by increasing the amount of strain. Our finding that large gaps between bone segments were not as well healed as were smaller gaps suggests that it is advantageous to avoid large gaps in fracture treatment.
Defects of the dorsal and ventral ligament complexes of the lumbar spine results to an instability of the functional spinal unit. For the prognosis of secondary instability due to disko-ligamentous injuries the functional insufficiency of the lasting scars is a larger problem than the primary loss of osseous stability with fast healing tendency. The main goal of the present biomechanical study in vitro was to demonstrate the different grades of instability in the correlation to progressive disko-ligamentous defects as well as stabilisation through dynamic and static procedures. With a transpedicular screw-ringband-system the segmental function was preserved and instability was abolished. After rigid instrumentation with a fixateur intern remained a residual range of motion due to which can result refuse to bending moments without spondylodesis in an implant failure.
New implants and new surgical approaches should be tested in vitro for primary stability in standardized laboratory tests in order to decide the most appropriate approach before being accepted for clinical use. Due to the complex and still unknown loading of the spine in vivo a variety of different test loading conditions have been used, making comparison of the results from different groups almost impossible. This recommendation was developed in a series of workshops with research scientists, orthopedic and trauma surgeons, and research and development executives from spinal implant companies. The purpose was to agree on in vitro testing conditions that would allow results from various research groups to be compared. This paper describes the recommended loading methods, specimen conditions, and analysis parameters resulting from these workshops.
Laminectomy is the accepted treatment for spinal canal stenosis in cases where conservative treatment has failed. Opinions diverge on the resulting clinical instability and the necessity of instrumented stabilization. The present biomechanical study was performed to determine the functional impairment following laminectomy and the stabilizing effect of flexible and rigid devices. This was the first time that the effects of agonist and antagonist intersegmental lumbar muscle forces acting on intact, unstable and instrumentally stabilized functional spinal units have been investigated. Six human cadaveric lumbar spines were tested in a spine tester. The coactivation of agonist and antagonist muscle forces resulted in increased stability under the load conditions of bending and rotation; a slight increase in the range of motion was noted during flexion. The functional impairment following laminectomy was corrected by ligamentoplasty and by means of muscle forces. Ligamentoplasty appears to be an alternative to decompression with spondylodesis, especially in patients with well-developed muscles.