The Pararectus approach for anterior intrapelvic management of acetabular fractures: an anatomical study and clinical evaluation

A new anterior intrapelvic approach for the surgical management of displaced acetabular fractures involving predominantly the anterior column and the quadrilateral plate is described. In order to establish five 'windows' for instrumentation, the extraperitoneal space is entered along the lateral border of the rectus abdominis muscle. This is the so-called 'Pararectus' approach. The feasibility of safe dissection and optimal instrumentation of the pelvis was assessed in five cadavers (ten hemipelves) before implementation in a series of 20 patients with a mean age of 59 years (17 to 90), of whom 17 were male. The clinical evaluation was undertaken between December 2009 and December 2010. The quality of reduction was assessed with post-operative CT scans and the occurrence of intra-operative complications was noted. In cadavers, sufficient extraperitoneal access and safe instrumentation of the pelvis were accomplished. In the patients, there was a statistically significant improvement in the reduction of the fracture (pre- versus post-operative: mean step-off 3.3 mm (sd 2.6) vs 0.1 mm (sd 0.3), p < 0.001; and mean gap 11.5 mm (sd 6.5) vs 0.8 mm (sd 1.3), p < 0.001). Lesions to the peritoneum were noted in two patients and minor vascular damage was noted in a further two patients. Multi-directional screw placement and various plate configurations were feasible in cadavers without significant retraction of soft tissues. In the treatment of acetabular fractures predominantly involving the anterior column and the quadrilateral plate, the Pararectus approach allowed anatomical restoration with minimal morbidity related to the surgical access.

A self-developed and constructed robot for minimally invasive cochlear implantation

Conclusion: A robot built specifically for stereotactic cochlear implantation provides equal or better accuracy levels together with a better integration into a clinical environment, when compared to existing approaches based on industrial robots. Objectives: To evaluate the technical accuracy of a robotic system developed specifically for lateral skull base surgery in an experimental setup reflecting the intended clinical application. The invasiveness of cochlear electrode implantation procedures may be reduced by replacing the traditional mastoidectomy with a small tunnel slightly larger in diameter than the electrode itself. Methods: The end-to-end accuracy of the robot system and associated image-guided procedure was evaluated on 15 temporal bones of whole head cadaver specimens. The main components of the procedure were as follows: reference screw placement, cone beam CT scan, computer-aided planning, pair-point matching of the surgical plan, robotic drilling of the direct access tunnel, and post-operative cone beam CT scan and accuracy assessment. Results: The mean accuracy at the target point (round window) was 0.56 ± 41 mm with an angular misalignment of 0.88 ± 0.41°. The procedural time of the registration process through the completion of the drilling procedure was 25 ± 11 min. The robot was fully operational in a clinical environment.

High-accuracy patient-to-image registration for the facilitation of image-guided robotic microsurgery on the head

Image-guided microsurgery requires accuracies an order of magnitude higher than today's navigation systems provide. A critical step toward the achievement of such low-error requirements is a highly accurate and verified patient-to-image registration. With the aim of reducing target registration error to a level that would facilitate the use of image-guided robotic microsurgery on the rigid anatomy of the head, we have developed a semiautomatic fiducial detection technique. Automatic force-controlled localization of fiducials on the patient is achieved through the implementation of a robotic-controlled tactile search within the head of a standard surgical screw. Precise detection of the corresponding fiducials in the image data is realized using an automated model-based matching algorithm on high-resolution, isometric cone beam CT images. Verification of the registration technique on phantoms demonstrated that through the elimination of user variability, clinically relevant target registration errors of approximately 0.1 mm could be achieved.

Long-Term Outcome After Monosegmental L4/5 Stabilization for Degenerative Spondylolisthesis With the Dynesys Device

STUDY DESIGN:: retrospective analysis of prospectively collected clinical data. OBJECTIVE:: To assess the long-term outcome of patients with monosegmental L4/5 degenerative spondylolisthesis treated with the dynamic Dynesys device. SUMMARY OF BACKGROUND DATA:: The Dynesys® system has been used as a semirigid, lumbar dorsal pedicular stabilization device since 1994. Good short-term results have been reported, but little is known about the long-term outcome following treatment for degenerative spondylolisthesis at the L4/5 level. METHODS:: 39 consecutive patients with symptomatic degenerative lumbar spondylolisthesis at the L4/5 level were treated with bilateral decompression and Dynesys instrumentation. At a mean follow-up of 7.2 years (range 5.0-11.2▒y) they underwent clinical and radiographic evaluation and quality of life assessment. RESULTS:: At final follow-up back pain improved in 89% and leg pain improved in 86% of patients compared to preoperative status. 83% of patients reported global subjective improvement. 92% would undergo the surgery again. 8 patients (21%) required further surgery due to symptomatic adjacent segment disease (6 cases), late onset infection (1 case), and screw breakage (1 case). In 9 cases radiological progression of spondylolisthesis at the operated segment was found. 74% of operated segments showed limited flexion-extension range of less than 4°. Adjacent segment pathology, though without clinical correlation, was diagnosed at the L5/S1 (17.9%) and L3/4 (28.2%) segments. In 4 cases asymptomatic screw loosening was observed. CONCLUSION:: Monosegmental Dynesys instrumentation of degenerative spondylolisthesis at L4/5 shows good long-term results. The rate of secondary surgeries is comparable to other dorsal instrumentation devices. Residual range of motion in the stabilized segment is reduced, and the rate of radiological and symptomatic adjacent segment degeneration is low. Patient satisfaction is high. Dynesys stabilization of symptomatic L4/5 degenerative spondylolisthesis is a possible alternative to other stabilization devices.

Population-based design of mandibular fixation plates with bone quality and morphology considerations

In this paper we present a new population-based implant design methodology, which advances the state-of-the-art approaches by combining shape and bone quality information into the design strategy. The method may enhance the mechanical stability of the fixation and reduces the intra-operative in-plane bending which might impede the functionality of the locking mechanism. The computational method is presented for the case of mandibular locking fixation plates, where the mandibular angle and the bone quality at screw locations are taken into account. The method automatically derives the mandibular angle and the bone thickness and intensity values at the path of every screw from a set of computed tomography images. An optimization strategy is then used to optimize the two parameters of plate angle and screw position. The method was applied to two populations of different genders. Results for the new design are presented along with a comparison with a commercially available mandibular locking fixation plate (MODUS(®) TriLock(®) 2.0/2.3/2.5, Medartis AG, Basel, Switzerland). The proposed designs resulted in a statistically significant improvement in the available bone thickness when compared to the standard plate. There is a higher probability that the proposed implants cover areas of thicker cortical bone without compromising the bone mineral density around the screws. The obtained results allowed us to conclude that an angle and screw separation of 129° and 9 mm for females and 121° and 10 mm for males are more suitable designs than the commercially available 120° and 9 mm.

Correlation of Pullout Force of Kirschner (K-) Wire to Other Factors Indicative of Bone Quality

More than 250,000 hip fractures occur annually in the United States and the most common fracture location is the femoral neck, the weakest region of the femur. Hip fixation surgery is conducted to repair hip fractures by using a Kirschner (K-) wire as a temporary guide for permanent bone screws. Variation has been observed in the force required to extract the K-wire from the femoral head during surgery. It is hypothesized that a relationship exists between the K-wire pullout force and the bone quality at the site of extraction. Currently, bone mineral density (BMD) is used as a predictor for bone quality and strength. However, BMD characterizes the entire skeletal system and does not account for localized bone quality and factors such as lifestyle, nutrition, and drug use. A patient’s BMD may not accurately describe the quality of bone at the site of fracture. This study aims to investigate a correlation between the force required to extract a K-wire from femoral head specimens and the quality of bone. A procedure to measure K-wire pullout force was developed and tested with pig femoral head specimens. The procedure was implemented on 8 human osteoarthritic femoral head specimens and the average pullout force for each ranged from 563.32 ± 240.38 N to 1041.01 ± 346.84 N. The data exhibited significant variation within and between each specimen and no statistically significant relationships were determined between pullout force and patient age, weight, height, BMI, inorganic to organic matter ratio, and BMD. A new testing fixture was designed and manufactured to merge the clinical and research environments by enabling the physician to extract the K-wire from each bone specimen himself. The new device allows the physician to gather tactile feedback on the relative ease of extraction while load history is recorded similar to the previous procedure for data acquisition. Future work will include testing human bones with the new device to further investigate correlations for predicting bone quality.

Solid-State Compatibilization of Immiscible Polymer Blends: Cryogenic Milling and Solid-State Shear Pulverization

The blending of common polymers allows for the rapid and facile synthesis of new materials with highly tunable properties at a fraction of the costs of new monomer development and synthesis. Most blends of polymers, however, are completely immiscible and separate into distinct phases with minimal phase interaction, severelydegrading the performance of the material. Cross-phase interactions and property enhancement can be achieved with these blends through reactive processing or compatibilizer addition. A new class of blend compatibilization relies on the mechanochemical reactions between polymer chains via solid-state, high energy processing. Two contrasting mechanochemical processing techniques are explored in this thesis: cryogenic milling and solid-state shear pulverization (SSSP). Cryogenic milling is a batch process where a milling rod rapidly impacts the blend sample while submerged within a bath of liquid nitrogen. In contrast, SSSP is a continuous process where blend components are subjected to high shear and compressive forces while progressing down a chilled twin-screw barrel. In the cryogenic milling study, through the application of a synthesized labeledpolymer, in situ formation of copolymers was observed for the first time. The microstructures of polystyrene/high-density polyethylene (PS/HDPE) blends fabricated via cryomilling followed by intimate melt-state mixing and static annealing were found to be morphologically stable over time. PS/HDPE blends fabricated via SSSP also showed compatibilization by way of ideal blend morphology through growth mechanisms with slightly different behavior compared to the cryomilled blends. The new Bucknell University SSSP instrument was carefully analyzed and optimized to produce compatibilized polymer blends through a full-factorial experiment. Finally, blends of varying levels of compatibilization were subjected to common material tests to determine alternative means of measuring and quantifying compatibilization,

The Crystallization Kinetics of Polylactic Acid (Pla) Processed Through Solid-State/Melt Extrusion

Polylactic acid (PLA) is a bio-derived, biodegradable polymer with a number of similar mechanical properties to commodity plastics like polyethylene (PE) and polyethylene terephthalate (PETE). There has recently been a great interest in using PLA to replace these typical petroleum-derived polymers because of the developing trend to use more sustainable materials and technologies. However, PLA¿s inherent slow crystallization behavior is not compatible with prototypical polymer processing techniques such as molding and extrusion, and in turn inhibits its widespread use in industrial applications. In order to make PLA into a commercially-viable material, there is a need to process the material in such a way that its tendency to form crystals is enhanced. The industry standard for producing PLA products is via twin screw extrusion (TSE), where polymer pellets are fed into a heated extruder, mixed at a temperature above its melting temperature, and molded into a desired shape. A relatively novel processing technique called solid-state shear pulverization (SSSP) processes the polymer in the solid state so that nucleation sites can develop and fast crystallization can occur. SSSP has also been found to enhance the mechanical properties of a material, but its powder output form is undesirable in industry. A new process called solid-state/melt extrusion (SSME), developed at Bucknell University, combines the TSE and SSSP processes in one instrument. This technique has proven to produce moldable polymer products with increased mechanical strength. This thesis first investigated the effects of the TSE, SSSP, and SSME polymer processing techniques on PLA. The study seeks to determine the process that yields products with the most enhanced thermal and mechanical properties. For characterization, percent crystallinity, crystallization half time, storage modulus, softening temperature, degradation temperature and molecular weight were analyzed for all samples. Through these characterization techniques, it was observed that SSME-processed PLA had enhanced properties relative to TSE- and SSSP-processed PLA. Because of the previous findings, an optimization study for SSME-processed PLA was conducted where throughput and screw design were varied. The optimization study determined PLA processed with a low flow rate and a moderate screw design in an SSME process produced a polymer product with the largest increase in thermal properties and a high retention of polymer structure relative to TSE-, SSSP-, and all other SSME-processed PLA. It was concluded that the SSSP part of processing scissions polymer chains, creating defects within the material, while the TSE part of processing allows these defects to be mixed thoroughly throughout the sample. The study showed that a proper SSME setup allows for both the increase in nucleation sites within the polymer and sufficient mixing, which in turn leads to the development of a large amount of crystals in a short period of time.

Harvesting local cylinder autograft from adjacent vertebral body for anterior lumbar interbody fusion: surgical technique, operative feasibility and preliminary clinical results

Autogenous iliac crest has long served as the gold standard for anterior lumbar arthrodesis although added morbidity results from the bone graft harvest. Therefore, femoral ring allograft, or cages, have been used to decrease the morbidity of iliac crest bone harvesting. More recently, an experimental study in the animal showed that harvesting local bone from the anterior vertebral body and replacing the void by a radio-opaque beta-tricalcium phosphate plug was a valid concept. However, such a concept precludes theoretically the use of posterior pedicle screw fixation. At one institution a consecutive series of 21 patients underwent single- or multiple-level circumferential lumbar fusion with anterior cages and posterior pedicle screws. All cages were filled with cancellous bone harvested from the adjacent vertebral body, and the vertebral body defect was filled with a beta-tricalcium phosphate plug. The indications for surgery were failed conservative treatment of a lumbar degenerative disc disease or spondylolisthesis. The purpose of this study, therefore, was to report on the surgical technique, operative feasibility, safety, benefits, and drawbacks of this technique with our primary clinical experience. An independent researcher reviewed all data that had been collected prospectively from the onset of the study. The average age of the patients was 39.9 (26-57) years. Bone grafts were successfully harvested from 28 vertebral bodies in all but one patient whose anterior procedure was aborted due to difficulty in freeing the left common iliac vein. This case was converted to a transforaminal interbody fusion (TLIF). There was no major vascular injury. Blood loss of the anterior procedure averaged 250 ml (50-350 ml). One tricalcium phosphate bone plug was broken during its insertion, and one endplate was broken because of wrong surgical technique, which did not affect the final outcome. One patient had a right lumbar plexopathy that was not related to this special technique. There was no retrograde ejaculation, infection or pseudoarthrosis. One patient experienced a deep venous thrombosis. At the last follow up (mean 28 months) all patients had a solid lumbar spine fusion. At the 6-month follow up, the pain as assessed on the visual analog scale (VAS) decreased from 6.9 to 4.5 (33% decrease), and the Oswestry disability index (ODI) reduced from 48.0 to 31.7 with a 34% reduction. However, at 2 years follow up there was a trend for increase in the ODI (35) and VAS (5). The data in this study suggest that harvesting a cylinder of autograft from the adjacent vertebral body is safe and efficient. Filling of the void defect with a beta-tricalcium phosphate plug does not preclude the use of posterior pedicle screw stabilization.

Quality and quantity of bone following alveolar distraction osteogenesis in the human mandible

PURPOSE: The purpose of this prospective study on humans were to evaluate (a) the clinical outcome of alveolar distraction osteogenesis for the correction of vertically deficient edentulous mandibular ridges, (b) the clinical outcome of dental implants placed in the distracted areas, and (c) the quality and quantity of the bone that had formed in the distraction gap. MATERIAL AND METHODS: Seven patients presenting vertically deficient edentulous ridges were treated by means of distraction osteogenesis with an intraoral alveolar distractor. Approximately 3 months after consolidation of the distracted segments, 20 ITI solid screw SLA implants were placed in the distracted areas. Three to 4 months later, abutments were connected and prosthetic loading of the implants started. During implant site preparation, bone biopsies were taken at the implant sites with trephine burrs for histologic and histometric analyses. RESULTS: The mean follow-up after the initial prosthetic loading was 18 months (range 12-24 months). The mean bone gain obtained at the end of distraction was 7 mm (range 5-9 mm). The cumulative success rate of implants 2 years after the onset of prosthetic loading was 95%, whereas the survival rate of implants was 100%. The newly formed bone consisted of woven bone reinforced by parallel-fibered bone with bone marrow spaces between the bone trabeculae. The bone area fraction in the distraction region ranged from 21.6% to 57.8% (38.5+/-11.7%). DISCUSSION AND CONCLUSIONS: Results from this study showed that (a) distraction osteogenesis is a reliable technique for the correction of vertically deficient edentulous ridges, (b) the regenerated bone withstood the functional demands of implant loading, (c) survival and success rates of implants placed in the distracted areas were consistent with those of implants placed in native bone, and (d) there is sufficient bone volume and maturity in the distracted region for primary stability of the implant.

Validity and clinical significance of biomechanical testing of implant/bone interface

Purpose: The aim of this paper was to review the clinical literature on the Resonance frequency analysis (RFA) and Periotest techniques in order to assess the validity and prognostic value of each technique to detect implants at risk for failure. Material and methods: A search was made using the PubMed database to find clinical studies using the RFA and/or Periotest techniques. Results: A limited number of clinical reports were found. No randomized-controlled clinical trials or prospective cohort studies could be found for validity testing of the techniques. Consequently, only a narrative review was prepared to cover general aspects of the techniques, factors influencing measurements and the clinical relevance of the techniques. Conclusions: Factors such as bone density, upper or lower jaw, abutment length and supracrestal implant length seem to influence both RFA and Periotest measurements. Data suggest that high RFA and low Periotest values indicate successfully integrated implants and that low/decreasing RFA and high/increasing Periotest values may be signs of ongoing disintegration and/or marginal bone loss. However, single readings using any of the techniques are of limited clinical value. The prognostic value of the RFA and Periotest techniques in predicting loss of implant stability has yet to be established in prospective clinical studies. To cite this article: Aparicio C, Lang N P, Rangert B. Validity and clinical significance of biomechanical testing of implant/bone interface. Clin. Oral Imp. Res., 17 (Suppl. 2), 2006; 2-7.

[The SPI implant system: clinical experience and one-year results]

The new Swiss implant system SPI became available three years ago and is used in combination with fixed and removable prosthetic reconstructions. In a pilot study the clinical procedures were evaluated and data of prosthetic complications of maintenance service were collected. 25 patients participated in the study with a total of 79 SPI implants during the time period from 2003-2004. 37 implants were located in the maxilla and 42 implants in the mandible. Two implants failed during the healing period, but no loaded implant was lost. Thus, the survival rate was 97.5% (77/79). 44 implants supported a fixed prosthesis, including nine single crowns and 33 implants were used in combination with removable partial denture. Four implants were used with ball anchor retention, 29 with bar support. The ELEMENT implant with the low implant shoulder allows very good esthetics. Prosthetic complications and maintenance service during the first year of function was comparable with other implant systems. Since the design of the abutment screws, healing caps and screwdriver was changed, the system has become easier in its application.

Clinical field trial examining an implant with a sand-blasted, acid-etched surface

BACKGROUND: Conventionally, endosseous dental implants have required 3 to 6 months of uninterrupted healing based on observations for dental implants that were characterized by a relatively smooth machined surface. Many studies have since demonstrated that implants with a roughened surface resulted in greater bone apposition, earlier bone contact, and a stronger bond between the implant and the bone, suggesting that implants with roughened surfaces could be loaded earlier than 3 to 6 months. Formal clinical studies confirmed that implants with rough surfaces can have abutments placed and be loaded occlusally as early as 6 weeks postplacement. The purpose of this prospective, human clinical investigation was to evaluate a large number of implants with a specific rough surface (sand-blasted acid-etched [SLA]) placed in everyday practice under routine private-practice conditions. METHODS: A prospective, multicenter, human clinical observational study was initiated with the goal of recruiting a minimum of 500 patients and 800 implants. The implants were to be placed and restored in predominantly private-practice settings around the world. Ninety-two practitioners in 16 countries agreed to participate, and 86 followed the study design. Patients had to be in good health, have sufficient bone to encase the implant, and agree to return for recall appointments. Exclusion criteria included heavy smoking (>10 cigarettes a day) and bone augmentation procedures at the implant site. All implants were two-piece (an abutment was to be placed after 6 weeks of healing) and were characterized by the presence of a transmucosal polished collar. Each implant had an SLA surface. All implants were positioned using a non-submerged (single-stage) surgical technique. Survival and success rates were calculated by life-table analyses. RESULTS: A total of 706 patients were enrolled and 1,406 implants were placed. In the final analyses, 590 patients with 990 implants (70.4% of those enrolled) met all inclusion criteria, including placement of an abutment and provisional restoration within 63 days of surgical placement. The majority of implants were 10 and 12 mm long (78.7%) and were placed in type II and III bone (87%). Seventy-three percent of the implants were placed in the mandible, and 27% were placed in the maxilla. The cumulative survival rate was 99.56% at 3 years and 99.26% at 5 years. The overall success rate was 99.12% at 3 years and 97.38% after 5 years. CONCLUSIONS: Under private-practice conditions, implants with an SLA surface could be placed and restored predictably within 6 to 8 weeks. Data from this prospective, multicenter, human observational study reinforced the results of more formal clinical studies and demonstrated that implants with the SLA surface can be restored in patients in approximately half of the time of conventional healing periods.

Immediate implant placement with transmucosal healing in areas of aesthetic priority. A multicentre randomized-controlled clinical trial I. Surgical outcomes

OBJECTIVES: To compare the clinical outcomes of standard, cylindrical, screw-shaped to novel tapered, transmucosal (Straumann Dental implants immediately placed into extraction sockets. Material and methods: In this randomized-controlled clinical trial, outcomes were evaluated over a 3-year observation period. This report deals with the need for bone augmentation, healing events, implant stability and patient-centred outcomes up to 3 months only. Nine centres contributed a total of 208 immediate implant placements. All surgical and post-surgical procedures and the evaluation parameters were discussed with representatives of all centres during a calibration meeting. Following careful luxation of the designated tooth, allocation of the devices was randomly performed by a central study registrar. The allocated SLA titanium implant was installed at the bottom or in the palatal wall of the extraction socket until primary stability was reached. If the extraction socket was >or=1 mm larger than the implant, guided bone regeneration was performed simultaneously (Bio Oss and BioGide. The flaps were then sutured. During non-submerged transmucosal healing, everything was done to prevent infection. At surgery, the need for augmentation and the degree of wound closure was verified. Implant stability was assessed clinically and by means of resonance frequency analysis (RFA) at surgery and after 3 months. Wound healing was evaluated after 1, 2, 6 and 12 weeks post-operatively. RESULTS: The demographic data did not show any differences between the patients receiving either standard cylindrical or tapered implants. All implants yielded uneventful healing with 15% wound dehiscences after 1 week. After 2 weeks, 93%, after 6 weeks 96%, and after 12 weeks 100% of the flaps were closed. Ninety percent of both implant designs required bone augmentation. Immediately after implantation, RFA values were 55.8 and 56.7 and at 3 months 59.4 and 61.1 for cylindrical and tapered implants, respectively. Patient-centred outcomes did not differ between the two implant designs. However, a clear preference of the surgeon's perception for the appropriateness of the novel-tapered implant was evident. CONCLUSIONS: This RCT has demonstrated that tapered or standard cylindrical implants yielded clinically equivalent short-term outcomes after immediate implant placement into the extraction socket.

Performance of dental implants after staged sinus floor elevation procedures: 5-year results of a prospective study in partially edentulous patients

OBJECTIVES: The aim of this prospective study was to evaluate the 5-year performance and success rate of titanium screw-type implants with the titanium plasma spray (TPS) or the sand-blasted, large grit, acid-etched (SLA) surface inserted in a two-stage sinus floor elevation (SFE) procedure in the posterior maxilla. MATERIAL AND METHODS: A total of 59 delayed SFEs were performed in 56 patients between January 1997 and December 2001, using a composite graft with autogenous bone chips combined with deproteinized bovine bone mineral (DBBM) or synthetic porous beta-tricalcium phosphate (beta-TCP). After a healing period averaging 7.75 months, 111 dental implants were inserted. After an additional 8-14-week healing period, all implants were functionally loaded with cemented crowns or fixed partial dentures. The patients were recalled at 12 and 60 months for clinical and radiographic examination. RESULTS: One patient developed an acute infection in the right maxillary sinus after SFE and did not undergo implant therapy. Two of the 111 inserted implants had to be removed because of a developing atypical facial pain, and 11 implants were lost to follow-up and were considered drop-outs. The remaining 98 implants showed favorable clinical and radiographic findings at the 5-year examination. The peri-implant soft tissues were stable over time; the mean probing depths and mean attachment levels did not change during the follow-up period. The measurement of the bone crest levels (DIB values) indicated stability as well. Based on strict success criteria, all 98 implants were considered successfully integrated, resulting in a 5-year success rate of 98% (for TPS implants 89%, for SLA implants 100%). CONCLUSION: This prospective study assessing the performance of dental implants inserted after SFE demonstrated that titanium implants can achieve and maintain successful tissue integration with high predictability for at least 5 years of follow-up in carefully selected patients.