Comparison of position repeatability of a human operator and an industrial manipulating robot

STATEMENT OF PROBLEM: Implant-supported restorations in the partially edentulous jaw have been performed at the Mayo Clinic for more than 10 years. Clinical performance of the implants and the prostheses should be reported to ensure effectiveness of this procedure. PURPOSE: This retrospective study described results for implant survival, implant fracture rate, prosthetic complications, and design changes that may impact these results. MATERIAL AND METHODS: A retrospective chart review was conducted of all registered implant patients in a large multispecialty medical center. Patients with a partially edentulous jaw who had received endosseous implants to support and retain dental prostheses were included in this review. Implant survival and fracture, prosthetic complications, and demographic data were recorded and analyzed through Kaplan-Meier methods. RESULTS: A total of 1170 implants were placed in four anatomic locations: anterior maxilla, posterior maxilla, anterior mandible, or posterior mandible. Location of implants was shown to have no effect on implant survival (p = 0.7398), implant fracture rates (p = 0.2385), screw loosening (p = 0.8253), or screw fracture (p = 0.2737). Development of new restorative components has resulted in significantly better rates of implant survival without fracture (p = 0.0054), screw function without loosening (p < 0.0001) and screw function without fracture (p = 0.0013). Implant survival seems to have been improved with the new components (p = 0.0513). CONCLUSIONS: Implant survival in this study was independent of anatomic location of implants. Virtually all clinical performance factors were improved by design changes in implant restorative components that were brought to market in early 1991.     

Metallic or absorbable fracture fixation devices. A cost minimization analysis

Absorbable polyester pins and screws for the internal fixation of small fragment fractures have been commercially available for several years. The main advantage of these devices is that no implant removal procedures are required, which could result in financial savings. The current cost analysis, which included costs of medical care plus costs of lost time from work, was based on 994 fracture patients treated with absorbable internal fixation devices and 1173 patients operated on using conventional metallic devices. The fracture types studied were uni- and trimalleolar fractures of the ankle, fractures of the olecranon, and metacarpal fractures. When the costs for an implant removal procedure after metallic fixation were included, the average cost saved per patient by using absorbable implants varied from $410 in fractures of the olecranon to $903 in unimalleolar fractures. However, hardware removals often are optional. According to the results of this cost analysis, the break even point is attained at a removal rate of 19% for metacarpal fractures, 21% for unimalleolar fractures, 46% for fractures of the olecranon, and 54% for trimalleolar fractures. Only at a higher removal rate would the use of absorbable devices, with their current prices, be a financially more favorable alternative than the use of metallic ones.     

Food and Drug Administration regulation of spinal implant fixation devices

The role of the Food and Drug Administration in regulating medical devices generally is not well understood by physicians. The practice of medicine does not fall under Food and Drug Administrations's regulatory purview. Nevertheless, the Food and Drug Administration and its regulation of medical devices can influence physicians' activities. This article provides an overview of the scope of the Food and Drug Administration's authority and the agency's regulatory framework, with particular focus on orthopaedic medical devices as related to spinal implant devices. During the past 10 years, a regulatory dilemma has arisen surrounding the use of bone screws in the pedicles of the spine. Except for recent clearances for a limited treatment indication, the Food and Drug Administration has not cleared these devices to be labeled for pedicle screw fixation and, therefore, has restricted industry supported educational activities pertaining to this type of treatment. In spite of the Food and Drug Administration's regulatory position, physicians have chosen to use pedicle screw fixation in treating patients who have a variety of spinal disorders. This use is now considered an accepted (state of the art) medical practice by many physicians for certain spinal conditions. This article explores this specific Food and Drug Administration regulatory issue, its impact on physicians and manufacturers (especially as it pertains to medical education), and recent actions taken to resolve it.     

Forces required to initiate sliding in second-generation intramedullary nails

Second-generation intramedullary nails, which allow the fixation screw that is placed in the femoral head to slide distally and thus allow compression of the fracture of the femoral neck, have become a popular option for the treatment of ipsilateral fractures of the femoral neck and shaft. However, the sliding characteristics of the screw within the barrel of the nail or the side-plate have not been assessed biomechanically, to our knowledge. The goal of the current study was to investigate the forces required to initiate sliding of the proximal screw in intramedullary devices and to compare these forces with those required to initiate sliding of hip screws. The loading configuration simulated the typical angle of 135 degrees between the intramedullary nail and the proximal screw. The forces required to initiate sliding of the proximal screw, with the screw extended fifty-one, seventy-six, eighty-six, and 102 millimeters beyond the proximal end of the barrel, were measured for three different types of second-generation intramedullary nails (Recon, ZMS, and Gamma), a sliding compression hip screw, and an intramedullary hip screw, and these forces were then compared. With each amount of extension of the screw, the hip screws required lower forces to initiate sliding than did the second-generation intramedullary devices. Of the second-generation devices, the Gamma nail required the highest forces to initiate sliding; the Recon and ZMS nails required 20 to 40 percent lower forces compared with the Gamma nail. None of the devices jammed in any of the loading configurations that were tested. When the extension of the screw was increased, higher forces were required to initiate sliding.     

Mechanical failure of the intramedullary hip screw in a subtrochanteric femoral fracture

The Gamma nail, an implant specifically designed for intertrochanteric and subtrochanteric femoral fractures, has been criticized for its high risk of secondary shaft fractures. A modified design, the intramedullary hip screw has recently been introduced to correct this complication. We present a case of mechanical failure of this new implant that occurred in a pathological subtrochanteric fracture. The centering sleeve of the implant became loose and migrated while the head screw penetrated the acetabulum. Refixation was successful.     

A comparison of a fluoroscopy-free mechanical targeting system and a free-hand technic for the placement of distal interlocking screws of tibial nails

Recently, radiation-independent aiming devices for the tibia which compensate for insertion-related implant deformation have been developed, but the benefits of such systems have not been determined. This study prospectively evaluated the duration of the nailing procedure, the length of radiation time, and the accuracy of interlocking screw placement with a radiation-independent distal aiming system and the free-hand technique. In an oblique cadaveric tibial fracture, a surgeon inexperienced with either technique performed a statically locked intramedullary nailing. For the aiming system and free-hand technique respectively, the total operation time was 25.4 +/- 11.3 vs 30.9 +/- 14.3 min (P = 0.029), the distal locking time was 16.7 +/- 8.6 vs 21.9 +/- 10.5 min (P = 0.004), the total fluoroscopy time was 9 +/- 5 vs 93 +/- 34 s (P < 0.0001), the distal locking fluoroscopy time was 0 versus 88 +/- 33 s (P < 0.0001), and the screw destruction was -0.7 +/- 5.2 vs 26.8 +/- 31.6 microns (P = 0.001). The failure rate was 1.6% (1 of 60 screws) in both groups. These results suggest that aiming devices can eliminate the need for radiation during distal interlocking screw placement.     

Biomechanical stress studies with a new Y-nail

The current success of the treatment of trochanteric fractures of the femur still depends on the type of fracture involved. A number of surgical procedures have proved successful in the treatment of stable fractures (e.g. dynamic hip screw, gamma nail). However, the treatment of unstable fractures remains a problem. With this type of fracture the implant is exposed to very unfavourable biomechanical loading that often leads to failure of the osteosynthesis, and makes removal of the implant necessary. In extensive tests, the biomechanical loading capacity of a new Y-nail has been investigated as a function of the stability and location of the fracture. The results show that this form of intramedullary fixing is suitable for both stable and unstable fractures. Unstable, far distal subtrochanteric fractures of the femur remain borderline indications.     

Orthofix external fixation of distal radius fractures: complications associated with screw size

We did a retrospective analysis of 28 patients who were treated with the Orthofix external fixation system for complex fractures of the distal radius to study complications associated with screw size. The 14 patients in group 1 had a 4.5/3.5-mm tapered screw placed in the metacarpal bone; the 14 patients in group 2 had a 3.5/3.3-mm tapered screw placed in the metacarpal bone. Both groups had 4.5/3.5-mm tapered screws placed in the radius. Two patients in group 1 had metacarpal pin tract infections; no patients in group 2 had a distal pin tract infection. Two patients in group 1 had a fracture of the metacarpal; only one patient in group 2 had a fracture of the metacarpal. In both groups two patients had proximal pin tract infections at the radius screw fixation site. There was no screw breakage in either group. The unique design of the tapered Orthofix screw allows it to be removed almost painlessly in the clinic. At installation in the operating room, however, the surgeon must remember not to back the threaded pin out for fine adjustment of bony penetration. Any reverse excursion of the threaded shaft will loosen the tapered screw and cause early failure of the fixation. We no longer use the 4.5/3.5-mm screw when managing wrist fractures with the Orthofix external fixation system. It is now our policy to use the 3.5/3.3-mm screw for fixation of the Orthofix external frame to both the metacarpal bone and the radius.     

Nitric oxide as a regulatory factor in sleep-wakefulness mechanisms

Most screws used in fracture fixation necessitate a separate step for tapping of the screw hole. Titanium screw systems have been developed in which the screws can be inserted directly after a drill hole is made. These self-tapping screws thereby eliminate an operative step. A retrospective study was conducted that evaluated all wrist and hand procedures performed between January 1992 and December 1994 by 1 surgeon using screw fixation. The results of 39 cases treated with standard tapped titanium screws were compared with 28 cases treated with self-tapping titanium screws. Nearly identical union and complication rates were obtained in each group. Comparable results can be obtained with self-tapping screw fixation, which limits the number of instruments needed, eliminates an operative step, and thereby may diminish operative risk and shorten operative time.     

Fractures after total knee joint endoprosthesis. Results of treatment with various stabilizing methods

In 20 patients with a fracture of femur or tibia 5.2 years after arthroplasty of knee the results of the operative treatment are presented. The results show that especially bone damaging diseases as rheumatoid arthritis, osteoporosis and the loosening of the endoprosthesis are favorable for the fracture during the follow-up. The conclusion of the investigation shows that in younger patients the external fixation by plates and screws is the preferential treatment, in elderly people or comminuted fracture an internal fixation, also in combination with an additional osteosynthesis, allows a fast mobilization. The number of observed complications is higher than in primary knee arthroplasty, the full weight bearing 1st delayed. The rate of further operations and unsatisfactory results is also higher being affected by the high mean age of the operated patients (73.4 years). The possible use of a total femur implant must be discussed critically because only an individual production can avoid further damage of the parts of the joint that were not concerned by the fracture.     

Small wire external fixation of high energy tibial plateau fractures

Open plate osteosynthesis for high energy tibial plateau fractures with dissociation between the metaphysis and diaphysis has been plagued with frequent soft tissue complications. The Harbor-University of California at Los Angeles Medical Center's experience with small wire external fixation supplemented by limited internal fixation is examined. This alternative method of adequate stable fixation offers the advantage of minimal soft tissue compromise. Twenty-four patients with Schatzker Type VI tibial fractures were treated with small wire external fixation. Supplementary limited internal fixation was used with percutaneous screws in 10 patients and with open reduction in one patient. Sixteen patients had isolated fractures, and eight others suffered multiple injuries. Minimum followup was 12 months. All fractures healed. Complications included one septic knee, two infections at screw sites, and one 10 degrees knee flexion contracture. One knee had Grade 3 radiographic arthrosis, five had Grade 2, 10 had Grade 1, and eight showed no arthrosis. The outcomes (Knee Society clinical rating system) of this study compare favorably with outcomes described in reports published previously for this type of fracture, despite inclusion of eight multiply injured patients. This technique preserves the goals of early range of motion and stable fixation for these devastating injuries, while decreasing the observed major wound complications and nonunion rates. However, longer followup may reveal higher arthrosis rates, specifically in those fractures that were not anatomically reduced.     

Use of an internal fixator device to treat comminuted fractures of the distal radius: report of a technique

An internal fixator technique for stabilizing comminuted Colles fractures has been developed in the anatomy laboratory and used in 35 clinical cases. The Colles Fracture Plate (Biomet, Inc, Warsaw, Indiana) can be used to treat any comminuted Colles fracture for which an external fixator is considered proper management. We have determined, based on our surgical experience with both the internal and external fixator techniques, that internal fixation using the Colles Fracture Plate is technically just as simple as external fixation. In addition to requiring a significantly less expensive device, internal fixation using this technique offers the advantages of better patient acceptance and fewer complications. This report will be followed by a more comprehensive analysis of the technical outcome of this procedure to further substantiate the initial results presented here. The process of compiling and analyzing these data is under way.     

Biodegradable interlocking nails for fracture fixation

Serious problems such as stress shielding, allergic reactions, and corrosion are associated with the use of metallic fracture fixation devices in fractured long bones. Metal implants often are removed during a second retrieval operation after fracture healing has completed. A biocompatible implant that degrades slowly during implantation would obviate the need for a second operation and save the patient from considerable physical, psychologic, and financial discomfort. The biodegradable implant must provide the fractured limb sufficient support for a certain time, allowing early loading. A gradual transfer of load from the biodegradable implant to the bone would result in a better product of bone healing and avoid stress shielding. In an animal model using adult sheep, two types of biodegradable polymer interlocking nails were tested in comparison with a stainless steel interlocking nail. Fracture healing, mechanical properties of the bones, degradation behavior in vivo and in vitro, and tissue response were monitored during a 2 1/2-year followup study. To detect shifts in acid base relations caused by the release of acid compounds, pH measurements were performed. Fracture healing was unimpaired, and the mechanical test results of all three groups were excellent. Histologic analysis showed a mild inflammatory response, but no pH shifts were observed. The results of this study justify additional research on these promising materials.     

Intramedullary versus extramedullary fixation of subtrochanteric fractures. A biomechanical study

We compared two different subtrochanteric fracture fixation techniques, an intramedullary hip screw system (IMHS) and an extramedullary, dual sliding screw-plate system (MSP), to determine relative fixation stability. 6 matched pairs of osteosynthesized osteopenic cadaver femurs were axially loaded to 1000 N with concurrent, simulated abductor forces of 0%, 50%, or 86% of the applied head force. The initial loading sequence was made with uniaxial dynamization--the lag screw of the MSP locked and distal locking of the IMHS nail. Femoral head displacement and medial femoral strain were measured for intact femur controls, after fixation of a 2-part reverse oblique subtrochanteric fracture and finally a 3-part reverse oblique subtrochanteric fracture with a lateral wedge defect. The samples were then loaded at 750 N for 10(4) cycles with both devices uniaxially locked, followed by 10(4) cycles with both devices fully biaxially dynamized (unlocked). For the 2-part subtrochanteric fracture pattern, both devices exhibited similar inferior displacements of the femoral head (average 2.0 mm) and medial femoral strain (approximately 70% of intact). Increasing abductor forces decreased medial compressive strain but did not significantly affect head displacement. For the 3-part fracture model, the MSP demonstrated significantly less inferior displacement of the head (1.6 mm vs. 2.1 mm) and both devices demonstrated significantly decreased medial strain. After cycling, head displacement increased approximately 50% in both devices and medial strain increased slightly. After unlocking and cycling, the MSP group showed significant lateral displacement of the proximal fragment. The IMHS and MSP devices provide similar stability for fixation of 2-part and 3-part reverse oblique subtrochanteric fractures. In a biaxially dynamized, 3-part reverse oblique fracture, displacement of the proximal fragment can occur with the MSP.     

Nodules precipitated by methotrexate in chronic juvenile polyarticular arthritis

Poly-L-lactic acid (PLLA), a biodegradable polymer, is generally considered to be gradually degraded without causing any severe tissue reaction. However, we encountered a patient who developed foreign body gonitis caused by screw breakage after fixation of an intercondylar prominence fracture with PLLA screws. This case suggests that care should be taken when PLLA materials are used to fix intraarticular fractures.     

Chance fracture after pedicle screw fixation. A case report

STUDY DESIGN: A case of a Chance fracture through an instrumented pedicle is presented. The radiographic and intraoperative findings and management of this complication are reported. OBJECTIVE: To increase awareness of the complications of transpedicular screw fixation and to suggest a form of management of this unusual complication. SUMMARY OF BACKGROUND DATA: To the authors' knowledge, this is the first reported case of such a vertebral fracture occurring after pedicle screw fixation. METHODS: A 44-year-old man with athetoid cerebral palsy and a progressive thoracic kyphosis sustained a Chance fracture at the caudal end of the segmental instrumentation construct. RESULTS: Surgical intervention, including fracture reduction and extension of the instrumented fusion to the pelvis, provided effective restoration of physiologic sagittal alignment. CONCLUSION: Chance fracture after pedicle screw fixation can be successfully managed with surgical intervention.     

Expression of Fos protein in the rat central nervous system in response to noxious stimulation: effects of chronic inflammation of the superior cervical ganglion

OBJECTIVES: To compare treatments of complete fractures of the third metacarpal (MC) or metatarsal (MT) bone in horses and to identify factors that could impact prognosis. DESIGN: Retrospective case series. ANIMALS: 25 horses with fractures of the third MC or MT bone that were treated by use of internal fixation, external coaptation, or both. PROCEDURE: Medical records from the Veterinary Medical Data Base of horses treated for fractures of third MC or MT bone at Texas A&M University from 1980 to 1994 and Purdue University from 1980 to 1996 were reviewed. Information on signalment, results of physical and radiographic examinations, treatment, and outcome were obtained. For horses that had radiographic evidence of healing, long-term follow-up information was obtained by telephone contact with owners or referring veterinarians. RESULTS: Age, sex, weight, and limb affected were not related to outcome; however, affected horses were younger than the general hospital populations. Seventeen horses had open fractures at referral. Infection was the most common complication after surgery, with open fractures more likely to become infected. Nonunion in an infected fracture was the most common reason for postoperative failure (7 horses). Long-term follow-up was available for 16 horses; 11 of these had no complications related to surgical repair. CLINICAL IMPLICATIONS: Fractures of the MC or MT bone are not always associated with a poor prognosis in horses. Proper case selection, rigid fracture stabilization, and efforts to prevent or treat infection will improve success rate.     

Use of rigid external fixation in fractures of the mandibular condyle

In this article the use of a rigid external fixation system is proposed for the early treatment of condylar fractures. This method offers the advantage of not damaging the articular structures during reduction and allows early mobilization for a rapid recovery. In our Centre 28 patients have been treated with the rigid external fixation system, with good functional results. Of these 15 men and 13 women, 22 had a monocondylar fracture and 6 had a bicondylar fracture. In all the cases there was complete recovery of the occlusal stituation and of the mouth opening; no patient surgically treated with this method has ever presented problems of a local or general nature. The purpose of this report was to evaluate the use of external fixation for the treatment of extracapsular condylar fractures with luxation of the fragment out of the glenoid cavity.     

Treatment of cutout of a lag screw of a dynamic hip screw in an intertrochanteric fracture

Sixteen consecutive patients with cutout of a lag screw of a dynamic hip screw fixation in an intertrochanteric fracture were treated with reinsertion of a lag screw, bone cement supplementation in the neck-trochanter, and subtrochanteric valgus osteotomy. Postoperatively, patients were permitted to ambulate with protected weight-bearing. Fourteen patients were followed-up for at least 1 year (median 2 years; range 1-3 years), and all had a solid union. The union period took a median of 5 months, with a range of 3-7 months. Usually, union of an intertrochanteric fracture was faster than that of subtrochanteric osteotomy (P < 0.01). There were no complications of wound infection, loss of reduction, cutout of a lag screw, or osteonecrosis of the femoral head. From clinical and theoretical considerations, we conclude that despite cutout of a lag screw of a dynamic hip screw fixation being difficult to treat, out technique still can provide an excellent outcome. Therefore, we strongly recommend its wide use.     

Lidocaine does not depress reflex dilation of the pupil

INTRODUCTION: The goal of this study was to report and evaluate the place of external fixation in the treatment of trochanteric fractures in patients with high unacceptable operative risk to withstand conventional osteosynthesis. MATERIAL AND METHODS: From January 1990 to December 1991 (2 years period), 42 patients, 13 males and 29 female, mean age 84.1 years, suffering from trochanteric fracture and considered preoperatively as "poor medical status" were treated by external fixation and immediate mobilisation. The average operative time was 18 minutes and no blood transfusion was necessary per or post-operatively. The mean hospital stay was 19 days. RESULTS: All patients were followed up for 6 months post-operatively. During this time 8 patients (19 per cent) died due to medical problems unrelated to the fracture. All fractures united in an acceptable position at an average time of 10.4 weeks with no loss of reduction, no pin breakage, no deep infection. All hips were painless. Complications: proximal pin migration occurred in 3 patients (7 per cent) due to fracture impaction and superficial pin tract infection in 16 (38 per cent) with no further consequence. DISCUSSION: External fixation in trochanteric fractures has been applied since 1957 with good results. This series confirms the advantages of the method in patients with a high operative risk; these are short operative time, minimal blood loss, early mobilisation and acceptable morbidity and mortality rates, considering the old and senile age group with poor medical condition, not allowing conventional treatment. The minor complications such as superficial pin tract infection and proximal pin migration are easily controlled.