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PubMed2005

Final report of the safety assessment of methacrylate ester monomers used in nail enhancement products.

Methacrylate ester monomers are used in as artificial nail builders in nail enhancement products. They undergo rapid polymerization to form a hard material on the nail that is then shaped. While Ethyl Methacrylate is the primary monomer used in nail enhancement products, other methacrylate esters are also used. This safety assessment addresses 22 other methacrylate esters reported by industry to be present in small percentages as artificial nail builders in cosmetic products. They function to speed up polymerization and/or form cross-links. Only Tetrahydrofurfuryl Methacrylate was reported to the FDA to be in current use. The polymerization rates of these methacrylate esters are within the same range as Ethyl Methacrylate. While data are not available on all of these methacrylate esters, the available data demonstrated little acute oral, dermal, or i.p. toxicity. In a 28-day inhalation study on rats, Butyl Methacrylate caused upper airway irritation; the NOAEL was 1801 mg/m3. In a 28-day oral toxicity study on rats, t-Butyl Methacrylate had a NOAEL of 20 mg/kg/day. Beagle dogs dosed with 0.2 to 2.0 g/kg/day of C12 to C18 methacrylate monomers for 13 weeks exhibited effects only in the highest dose group: weight loss, emesis, diarrhea, mucoid feces, or salivation were observed. Butyl Methacrylate (0.1 M) and Isobutyl Methacrylate (0.1 M) are mildly irritating to the rabbit eye. HEMA is corrosive when instilled in the rabbit eye, while PEG-4 Dimethacrylate and Trimethylolpropane Trimethacrylate are minimally irritating to the eye. Dermal irritation caused by methacrylates is documented in guinea pigs and rabbits. In guinea pigs, HEMA, Isopropylidenediphenyl Bisglycidyl Methacrylate, Lauryl Methacrylate, and Trimethylolpropane Trimethacrylate are strong sensitizers; Butyl Methacrylate, Cyclohexyl Methacrylate, Hexyl Methacrylate, and Urethane Methacrylate are moderate sensitizers; Hydroxypropyl Methacrylate is a weak sensitizer; and PEG-4 Dimethacrylate and Triethylene Glycol Dimethacrylate are not sensitizers. Ethylene Glycol Dimethacrylate was not a sensitizer in one guinea pig study, but was a strong sensitizer in another. There is cross-reactivity between various methacrylate esters in some sensitization tests. Inhaled Butyl Methacrylate, HEMA, Hydroxypropyl Methacrylate, and Trimethylolpropane Trimethacrylate can be developmental toxicants at high exposure levels (1000 mg/kg/day). None of the methacrylate ester monomers that were tested were shown to have any endocrine disrupting activity. These methacrylate esters are mostly non-mutagenic in bacterial test systems, but weak mutagenic responses were seen in mammalian cell test systems. Chronic dermal exposure of mice to PEG-4 Dimethacrylate (25 mg, 2 x weekly for 80 weeks) or Trimethylolpropane Trimethacrylate (25 mg, 2 x weekly for 80 weeks) did not result in increased incidence of skin or visceral tumors. The carcinogenicity of Triethylene Glycol Dimethacrylate (5, 25, or 50%) was assessed in a mouse skin painting study (50 microl for 5 days/week for 78 weeks), but was not carcinogenic at any dose level tested. The Expert Panel was concerned about the strong sensitization and crossor co-reactivity potential of the methacrylate esters reviewed in this report. However, data demonstrated the rates of polymerization of these Methacrylates were similar to that of Ethyl Methacrylate and there would be little monomer available exposure to the skin. In consideration of the animal toxicity data, the CIR Expert Panel decided that these methacrylate esters should be restricted to the nail and must not be in contact with the skin. Accordingly, these methacrylate esters are safe as used in nail enhancement products when skin contact is avoided.

Animals↗
PubMed1999

Antegrade locked nailing for humeral shaft fractures.

Treatment results of antegrade locked nailing of acute humeral shaft fractures, including union rate and recovery of shoulder function, have been inconsistent. This led the current authors to hypothesize that implant design and surgical techniques might account for this inconsistency. In the current study, 47 fractures (38 acute; nine pathologic) in 47 patients achieved union with the techniques of closed nailing, short to long segment nailing, and fracture compression. Satisfactory recovery of shoulder function occurred because of minimal surgical trauma, prevention of impingement by the nail or locking screws, and prevention of axillary nerve injury or comminution of the humeral head. Forty-seven patients with 38 acute fractures and nine pathologic fractures were treated with humeral locked nails. Mean followup time was 21.4 months. With a single operation, all 38 acute fractures proceeded to eventual union; the average time to union was 7.8 weeks. Thirty-five patients had excellent or satisfactory recovery of shoulder function. Complications included slipout of the proximal screw, nail breakage, fragment displacement, and transient postoperative radial nerve palsy. All nine patients with pathologic fractures had substantial pain relief and increased arm function after surgery. The current study shows the reliability of antegrade locked nailing for proximal and middle third fractures of the humeral shaft.

Adult↗
PubMed1990

Successful use of reaming and intramedullary nailing of the tibia.

The records and radiographs of 87 patients with 88 fractures of the tibial diaphysis who underwent intramedullary reaming and nailing were retrospectively reviewed. The mean patient age was 37 years. Seventy fractures were closed, and 18 were open. The indications for nailing were failures of closed treatment (n = 48), nonunions (n = 24), multiple injuries (n = 14), and fixation of osteotomy (n = 2). Seventy-six patients with 77 nails who were followed for an average of 26.2 months were studied. For acute fractures, the average time to complete clinical and radiographic union was 5.3 months. For established nonunions, the average healing time was 9 months. The only fractures that failed to unit were nonunions developing from previously open Type III injuries. Angular deformities greater than 5 degrees did not occur. Significant tibial shortening occurred in only one fracture. Decreased motion in the ankle or knee was present in six patients. Major complications as a result of tibial nailing occurred in three patients: two deep infections and one patellar tendon rupture. Minor complications included 10 patients with pain at the nail insertion site necessitating removal in four patients, three patients with transient sensory peroneal nerve dysesthesias, and one patient with a superficial wound infection that cleared with local care. Nine patients required reoperation. Intramedullary reaming and nailing of the tibia can be used advantageously in the treatment of difficult fractures of the tibial shaft and their sequelae. Attention to the technical details of nail insertion will minimize the most frequent complications.

Adult↗
PubMedDate not supplied

Failure of exchange reamed intramedullary nails for ununited femoral shaft fractures.

OBJECTIVE: To determine the effectiveness of exchange reamed nails for treatment of aseptic femoral delayed unions and nonunions. DESIGN: Retrospective chart review. PATIENTS: Nineteen patients admitted to the Carolinas Medical Center Level I trauma center from 1990 to 1996 for repair of femoral shaft fracture nonunion following contemporary locked nailing performed at least six months previously. These patients showed no radiographic evidence of progression of fracture healing for three months and had clinical symptoms of nonunion. INTERVENTION: Exchange reamed nails to treat ununited femoral shaft fracture. MAIN OUTCOME MEASUREMENTS: Radiographic and clinical evidence of union of the fracture or of the necessity for additional procedures. RESULTS: In 53 percent of the patients the secondary procedure resulted in fracture union, whereas in 47 percent, one or more additional procedures were required. Eight of the nine fractures that did not unite with exchange nailing united after a subsequent procedure (bone grafting, compression plating, or nail dynamization). Neither the type of nonunion, the location of the shaft fracture, the use of static versus dynamic cross-locking, nor the use of tobacco products was statistically predictive of the need for additional procedures. CONCLUSIONS: Reevaluation of routine exchange nailing as the recommended treatment for aseptic femoral delayed union or nonunion may be required. A significant number of patients who undergo reamed exchange nailing will require additional procedures to achieve fracture healing.

Adult↗
PubMed2003

Proximal tibial fracture stability with intramedullary nail fixation using oblique interlocking screws.

OBJECTIVES: The purpose of this study was to evaluate the mechanical stability of oblique interlocking screws in supplementing intramedullary nail fixation of high proximal tibial fractures. DESIGN: In vitro experimental testing. SETTING Orthopaedic biomechanics laboratory, Sunnybrook and Women's College Health Sciences Center. PARTICIPANTS: Ten paired fresh-frozen human cadaver tibiae. INTERVENTION: One tibia of each pair was randomized to be instrumented with an intramedullary nail (M/DN; Zimmer, Warsaw, Indiana), while the other was stabilized with a 13-hole stainless steel lateral tibial head plate (Synthes AO/ASIF). Specimens were tested in varus-valgus (v/v), flexion-extension (f/e) and torsion, before and after a 2-cm gap osteotomy was performed in the proximal segment. Testing of the nailed tibiae was performed with and without oblique proximal screws. Bone density was physically determined by removing a core of trabecular bone from the distal end of each tibia following testing. MAIN OUTCOME MEASUREMENT: Biomechanical construct stability. RESULTS: The addition of the proximally placed oblique screws increased the stability of the nail construct in v/v by 50% (6.8 mm, P < 0.05), in f/e by 47% (7.2 mm, P < 0.05), and in torsion by 18% (3.0 degrees, P < 0.05). There was no significant difference observed between the stability of the intramedullary nail construct with oblique screws and the plated construct. Trabecular bone density had a significant effect in reducing stability (P < 0.05) in nail and plate fixation. CONCLUSION: The addition of oblique interlocking screws significantly improves the stability of a nailed proximal tibia fracture and provides comparable stability to a plate osteosynthesis.

Aged↗
PubMed2004

The relationship of proximal locking screws to the axillary nerve during antegrade humeral nail insertion of four commercially available implants.

OBJECTIVE: The purpose of this study was to determine the proximity of proximal interlocking mechanisms in 4 current antegrade humeral nails to the axillary nerve and its branches. DESIGN: Cadaveric study. SETTING: Anatomy laboratory. MAIN OUTCOME MEASURE: Anatomic relationships. METHODS: Four humeral nail designs (labeled SS, SL, SZ, and SN) were each inserted in successive antegrade fashion in 10 cadaveric upper extremity specimens. Three variables were measured: from acromion to the axillary nerve, from acromion to entry sites of proximal locking devices, and from locking devices to axillary nerves and their branches. RESULTS: In nail SS, the proximally directed oblique locking screw came into contact with the ascending branch of the axillary nerve in 6 of 10 specimens. Mean distance from spiral blades in nails SS and SL were 26 mm to the axillary nerve and 16 mm to its ascending branch. Interlocking screws for nails SZ, SN, and SL did not violate the axillary nerve or its branches in any specimen. Mean distance from lateral acromion to the axillary nerve measured 58.7 mm. CONCLUSION: Nail SS's oblique locking screw may injure the ascending branch of the axillary nerve. Three of the 4 nails tested did not endanger the axillary nerve. However, when transverse proximal locking screws are inserted from a lateral-to-medial direction, they may endanger an arborized axillary nerve. Blunt dissection should be performed with a visible path to bone before instrumentation to reduce the risk of axillary nerve injury.

Aged↗
PubMed2005

Intramedullary nailing following external fixation in femoral and tibial shaft fractures.

BACKGROUND: Intramedullary nailing is the standard of care for the definitive management of lower extremity long bone fractures. Occasionally, temporary external fixation is used in fractures with severe open wounds or vascular injury before definitive intramedullary nailing. Secondary intramedullary nailing following external fixation is somewhat controversial, especially with respect to the duration of external fixation that is allowable before the risk of infection following later nailing becomes too great. Several recent studies have provided further insight into this issue. OBJECTIVE: The primary objective is to evaluate infection and nonunion rates in patients treated with temporary external fixation and secondary intramedullary nailing for lower extremity long bone fractures. The secondary objective is to evaluate whether the duration of external fixation and the interval time (defined as the time from external fixator removal to intramedullary nailing) influence the risk of infection after intramedullary nailing.

External Fixators↗
PubMed2001

Nonunion after intramedullary nailing of humeral shaft fractures.

OBJECTIVE: To assess results of exchange nailing in nonunion after intramedullary (IM) nailing of humeral shaft fractures. METHODS: This was a retrospective study; 24 patients with nonunion after IM nailing of humeral shaft fractures were reviewed. In 13 cases, nonunion was treated using exchange nailing, and 11 patients were treated nonoperatively. Union was assessed from radiographs. Shoulder joint symptoms and function were assessed after a mean 4.7 years' follow-up using Constant-Murley scoring and self-administered questionnaires devised by L'Insalata et al. RESULTS: Single or repeated exchange nailing resulted in union in 6 of 13 patients. Shoulder joint function was satisfactory (mean Constant-Murley score of 72) for those patients whose fracture eventually united and poor (mean Constant-Murley score of 39) for those left with nonunion. CONCLUSION: Exchange nailing results in a poor union rate in nonunion after IM nailing of humeral shaft fractures. Permanent nonunion of the humeral shaft leaves the patient with severe disability.

Adult↗
PubMed2003

Slotted intramedullary hip screw nails reduce proximal mechanical unloading.

The current prospective and randomized study was done to determine whether fixation of intertrochanteric femoral fractures that lack a medial buttress with a dynamically locked intramedullary hip screw prevents proximal stress shielding. Stress shielding was evident by the presence of cortical hypertrophy at the level of the tip of the nail and often was associated with midthigh pain. Of the 80 patients enrolled in this trial, 64 still were alive after 1 year. Among these patients, 30 had the nail classically locked with two screws transfixing the nail in two separate holes (Group A), and 34 had the nail locked with one screw passing through a slot (Group B). The average duration of followup was 37 months (range, 12-49 months). Tolerance to dynamically locked nails was significantly better, with only one patient in Group B having cortical hypertrophy of the femur at the level of the tip of the nail, compared with six patients in Group A. Other outcomes were equal in both groups. Late tolerance to this new dynamically locked intramedullary hip screw is good, while retaining the known advantages of nailing of these fractures.

Aged↗
PubMed2005

Trochanteric nail insertion for the treatment of femoral shaft fractures.

OBJECTIVES: This study was designed to evaluate whether the use of a new femoral nail, specifically designed to be inserted through the greater trochanter, could eliminate the complications previously seen with insertion of straight nails through this entry portal for the treatment of femoral shaft fractures. DESIGN: Prospective, clinical trial. SETTING: Three level I trauma centers. PATIENTS: Sixty-one consecutive patients with femoral shaft fractures (50 closed and 11 open fractures) treated with antegrade nailing with insertion through the greater trochanter. INTERVENTION: All patients were treated in the supine position with a TAN nail (Trigen System, Smith & Nephew, Memphis, TN) inserted through the greater trochanter. MAIN OUTCOME MEASURE: Union, alignment, complications, and hip function. RESULTS: Forty-six of 57 (81%) surviving patients were available for follow-up at a minimum of 12 (range, 12-25) months. Union occurred in all but 1 fracture after the index procedure. No patient sustained iatrogenic fracture comminution, and there were no angular malunions. Pain was reported as slight in 6 patients and moderate in 2. Visual and videotaped gate analysis, performed on 24 patients, revealed symmetrical walking in 21. CONCLUSIONS: This study demonstrates that antegrade nailing of femoral shaft fractures with a specially designed nail inserted through a trochanteric starting point provides predictably high union rates and low rates of complications. Ease of entry and utility in patients with a large body habitus are advantages over conventional piriformis fossa entry techniques. Nailing through the greater trochanter with the patient supine is presently our treatment of choice for patients with femoral shaft fractures.

Adolescent↗
PubMed2006

Closed, locked intramedullary nailing of pediatric femoral shaft fractures through the tip of the greater trochanter.

BACKGROUND: Closed femoral nailing is universally accepted as the treatment of choice in almost all diaphyseal femoral fractures in adults. Numerous authors reported favorable results applying the same surgical technique in the adolescent patient group. Nevertheless, reports of complications such as avascular necrosis and alteration of the proximal femoral anatomy have dampened the initial enthusiasm. The purpose of this paper was to evaluate the possible effect of closed intramedullary nailing through the greater trochanter on the proximal femoral anatomy. METHODS: We report the results of intramedullary nailing in 20 skeletally immature patients (13 men and 7 women) with a mean age of 14.4 years (range, 11-16 years). All were treated with closed, reamed, percutaneously performed nailing, using the tip of the greater trochanter as the nail insertion point. The patients were followed for 29 months in average (range, 19-37 months). RESULTS: No major complication (limb length discrepancy, avascular necrosis, coxa valga) occurred during the observation period. All fractures healed clinically and radiographically within 9 weeks in average (8-13 weeks) and all patients returned to the preinjury activity level. The mean ATD difference was 1.10 +/- 3.51 (range, -5-7 mm, 95% CI -0,54/2,74, p = 0.177). The mean LTA distance difference was 0.3 mm (range, -6-5 mm, p = 0.158), the mean femoral length difference was 1.9 mm (-9-12 mm, p = 0.122) and the overall limb length difference was 1.4 mm (-25-20 mm, p = 0.178). The mean neck-shaft angle difference was 0.20 +/- 1.74 (range, -3-4, p = 0.612) and the mean neck width was 0.60 +/- 1.50 (range, -3-3, p = 0.09). Fourteen nails (70%) were removed within 13 months in average (range, 10-18 months) without any complications. CONCLUSION: This study showed that with strict adherence to a surgical technique that respects the growing proximal femur and its vascular anatomy, using the tip of the greater trochanter as an entry point to the femoral canal, the proven advantages of closed, intramedullary nailing can safely be offered to the adolescent patient population as well.

Adolescent↗
PubMed1993

Nail varnish allergy with far-reaching consequences.

Contact allergy to nail varnish is well-known, and toluene-sulphonamide formaldehyde resin (TSAfr) was identified as the main allergen in 1943. During the period October 1989-December 1991 we identified 18 cases of contact allergy to nail varnish. The aim of the study was to describe the clinical picture, patch-test results, course and socio-medical consequences. Seventeen of the 18 patients were patch-test positive to TSAfr and 17/18 were positive to their own nail varnishes. Fourteen of the 18 were also positive to one or more substances in the standard patch-test series. The lesions were scattered, involving the face, eyelids, neck and hands. Periungual lesions were recorded in 11/18. The dermatitis resolved within a few weeks when the use of nail varnish was stopped. The socio-medical consequences of contact allergy to nail varnish had been severe: sick leave (nine cases), hospitalization (four cases), cessation of visual-display-unit (VDU) work (two cases), and job-loss (two cases). Our conclusions are that contact allergy to nail varnish and TSAfr is common; the socio-medical consequences may be severe; periungual lesions occur more frequently than previously stated, and the presence of other contact allergies makes the diagnosis easy to miss. TSAfr should be included in the standard patch-test series and patients should also be tested with their own nail varnishes. The study illustrates the need for mandatory declaration of the ingredients of cosmetics, as is required in the U.S.A.

Adult↗
PubMed1992

Comparative efficacy and safety of amorolfine nail lacquer 5% in onychomycosis, once-weekly versus twice-weekly.

Amorolfine is a new topical antifungal of the phenylpropyl morpholine class which is highly active both in vitro and in vivo against yeasts, dermatophytes and moulds responsible for superficial fungal infections. Human pharmacological studies have established that amorolfine has a persistent antifungal effect in the nail bed and in the skin without being systemically absorbed. This has been confirmed by clinical work showing that amorolfine is effective in treating dermatomycoses and onychomycoses when administered as cream or nail lacquer. It is ineffective when given orally for systemic mycoses or bacterial infections in animals. In earlier studies a 5% concentration of amorolfine nail lacquer was found to produce a better cure rate in onychomycosis than a lower concentration of 2%. From data available on the penetration of amorolfine and on the persistence of mycologically relevant tissue concentrations, it appeared likely that once- or twice-weekly application of nail lacquer should suffice to produce a satisfactory therapeutic effect in onychomycosis. The aim of this investigation was to assess the efficacy and tolerability of 5% amorolfine nail lacquer given once versus twice weekly to patients with onychomycosis of finger nails and toe nails.

Administration, Topical↗
PubMed1995

Nail incorporation kinetics of terbinafine in onychomycosis patients.

Patients with toe-nail onychomycosis were treated with terbinafine (250 mg daily, n = 20) for either 6 or 12 weeks in a randomized double-blind study. Plasma and distal nail clippings were taken before initiation of therapy and 1, 6, 12, 18, 24, 36 and 48 weeks thereafter. Analytical data of terbinafine extracted from nail clippings or plasma were obtained by high-performance liquid chromatography (HPLC). Nail extracts and isolated HPLC terbinafine peaks were analysed using a combined gas chromatography-mass spectroscopy system (GC-MS) for unequivocal identification of the drug. Terbinafine could be detected in the distal nail in the majority of the patients within 1 week of starting therapy. Maximum terbinafine levels of 0.52 and 1.01 micrograms/g were measured after 18 weeks in the 6- and 12-week treatment groups, respectively. While plasma levels decreased rapidly after termination of therapy terbinafine was detected in the nails as long as 30 weeks (6 weeks treatment) and 36 weeks (12 weeks treatment) after termination of therapy at a range of 0.28-0.19 microgram/g. The drug concentrations measured at all time points are well above the minimum inhibitory concentration (MIC) for dermatophytes and other fungi. These data suggest that the drug reaches the nail plate rapidly and persists there for several months after cessation of active treatment.

Antifungal Agents↗
PubMed2006

Closed and open grade I and II tibial shaft fractures treated by reamed intramedullary nailing.

OBJECTIVE: To evaluate the results of closed and open grade I and II tibial shaft fractures treated by reamed nail and unreamed nailing. SUBJECTS AND METHODS: Between 1997 and 2000, 119 patients with tibial shaft fractures were treated with reamed tibial nails. Postoperatively 96 patients (70 closed and 26 grade I and II open fractures) were followed clinically and radiologically for up to 18 months. The nail was inserted either by patellar tendon splitting or by nonsplitting technique. The nail was inserted after overreaming by 1.5 mm. Postoperatively, patients with isolated tibial fracture were mobilized by permitting partial weight bearing on the injured leg for 6 weeks. Patients with associated ankle fractures were allowed to walk with a Sarmiento cast. RESULTS: Postoperatively, 6 (6.3%) patients developed a compartment syndrome after surgery. In 48 (50%) cases, dynamization of the nail was carried out after a mean period of 12 weeks for delayed union. Overall, a 90.6% union was obtained at a mean of 24 weeks without difference between closed or open fractures. Two (2.1%) patients with an open grade II fracture developed a deep infection requiring treatment. A 9.4% rate of malunion was observed. Eight (8.3%) patients developed screw failure without clinical consequences. At the last follow-up, 52% of patients with patellar tendon splitting had anterior knee pain, compared to those (14%) who did not have tendon splitting. CONCLUSION: Reamed intramedullary nail is a suitable implant in treating closed as well as grade I and II open tibial shaft fractures.

Adolescent↗
PubMed1997

A computer assisted orthopaedic surgical system for distal locking of intramedullary nails.

This paper presents a prototype system for computer assisted surgery, the purpose of which is to assist orthopaedic surgeons when performing distal locking of intramedullary nails. This system comprises three components, namely: an Intelligent Image Intensifier, a Trajectory Tactician and an Intelligent Trajectory Guide. The Intelligent Image Intensifier is an X-ray vision system that provides accurate X-ray images. Such images enable the Trajectory Tactician software to analyse the operation site and calculate the trajectory required for a screw to lock an intramedullary nail. This involves the capture of two X-ray images from which are extracted the projections of the nail's edge boundaries and its distal locking holes. Using an analytical mathematical model of the nail, the position and orientation of the nail is determined. The trajectory is then implemented by the surgeon using the Intelligent Trajectory Guide. Evaluation in the laboratory suggests that the system is capable of reliably inserting a locking screw into an intramedullary nail. The rapidity with which this computer assisted method achieves locking should benefit both patient and surgeon by reducing radiation dosage and the length of time required to lock a nail.

Bone Screws↗
PubMed1997

Pulmonary effects of fixation of a fracture with a plate compared with intramedullary nailing. A canine model of fat embolism and fracture fixation.

UNLABELLED: Fat-embolism syndrome and pulmonary dysfunction may develop in multiply injured patients who have a fracture of a long bone. Although early fixation of a fracture is beneficial, intramedullary nailing may exacerbate pulmonary dysfunction by causing additional embolization of marrow fat. We examined the pulmonary effects of the timing and method of fixation of a fracture in a canine fat-embolism model. Fat embolism was induced in forty-one adult dogs by reaming the ipsilateral femur and tibia followed by pressurization of the intramedullary canal. The animals were divided into a control group of eight dogs that had induction of fat embolism alone and an experimental group of thirty-three dogs that had induction of fat embolism and internal fixation of a transverse fracture of the middle of the contralateral femoral shaft. In the control group, four dogs each were killed four hours and twenty-four hours after induction of fat embolism. In the experimental group, a femoral fracture was created and fixation was performed four hours after embolic showering in fifteen animals and twenty-four hours after embolization in eighteen animals. The two experimental groups were subdivided according to the method of fixation of the fracture: eleven dogs each had application of a plate, nailing without reaming, and nailing with reaming. The pulmonary arterial pressure and the alveolar-arterial gradient were measured preoperatively, during induction of fat embolism, and as long as one hour after fixation of the fracture but before the animal was killed. The lungs, brain, and kidneys were examined for pathological and physiological evidence of intravascular fat. The intravascular fat persisted for twenty-four hours after induction of pulmonary fat embolism. Pulmonary arterial pressure remained elevated at four hours after the embolic showering, before creation and fixation of the fracture. By twenty-four hours after the induction of fat embolism, pulmonary arterial pressure had returned to the baseline level. Neither the creation nor the fixation of the fracture affected pulmonary arterial pressure. In the animals that had fixation of a fracture four hours after embolization, both nailing with reaming and nailing without reaming produced alveolar-arterial gradients that were higher than the baseline values, whereas fixation with a plate did not change the alveolar-arterial gradient significantly from the baseline value. In addition, the alveolar-arterial gradients in the animals that had nailing with reaming and nailing without reaming four hours after embolization were, respectively, four and 3.5 times higher than that in the animals that had fixation of the femur with a plate. In the animals that had fixation twenty-four hours after embolization, none of the methods for fixation affected the alveolar-arterial gradient. The amount of embolic fat in the lungs, brain, and kidneys was not affected by fixation of the fracture when it was performed at either the four-hour or the twenty-four-hour time-interval. Scores for pulmonary edema were increased by fixation of the fracture, but there was no difference among the scores associated with the three methods of fixation. CLINICAL RELEVANCE: The findings of the present study indicated that the amount of intravascular fat persisting in the lungs, kidneys, and brain twenty-four hours after pressurization of the intramedullary canal is not affected by the method of fixation of the fracture. Fixation of a fracture is associated with minimum evidence of acute inflammation and has no effect on pulmonary artery pressure. The development of pulmonary dysfunction from fat emboli depends on other factors, not just on the presence of fat in pulmonary vessels. It appears that the method of fracture fixation has little influence on the outcome of treatment.

Animals↗
PubMed2005

Operative treatment of tibial fractures in children: are elastic stable intramedullary nails an improvement over external fixation?

BACKGROUND: Operative treatment of tibial fractures in children requires implants that do not violate open physes while maintaining tibial length and alignment. Both elastic stable intramedullary nails and external fixation can be utilized. We retrospectively reviewed our experience with these two techniques to determine if one is superior to the other. METHODS: We retrospectively reviewed the operative records and trauma registries of three institutions within our hospital system and identified thirty-five consecutive patients with open physes who had undergone operative treatment of a tibial fracture between April 1997 and June 2004. Four patients were excluded because they had been managed with locked intramedullary nails or with pins and plaster. Of the thirty-one remaining patients, sixteen had been managed with elastic stable intramedullary nails and fifteen had been managed with unilateral external fixation. The clinical and radiographic outcomes were compared. The functional outcomes were compared with use of the Pediatric Outcomes Data Collection Instrument. Complications related to treatment, such as malunion, delayed union, nonunion, infection, and the need for subsequent surgical treatment also were compared. RESULTS: Thirty-one patients with thirty-one operatively treated tibial fractures were available for evaluation. Fifteen patients had been managed with external fixation. Seven of these patients had a closed fracture, and eight had an open fracture. There were seven healing complications in this group, including two delayed unions, three nonunions, and two malunions. Sixteen patients had been managed with elastic stable intramedullary nailing. Eleven patients had a closed fracture, and five had an open fracture. The mean time to union for the intramedullary nailing group (seven weeks) was significantly shorter than that for the external fixation group (eighteen weeks) (p < 0.01). The functional outcomes for the intramedullary nailing group were significantly better than those for the external fixation group in the categories of pain, happiness, sports, and global function (the mean of the mean scores of the first four categories) (p < 0.01 for these comparisons). CONCLUSIONS: When surgical stabilization of tibial fractures in children is indicated, we believe that the preferred method of fixation is with elastic stable intramedullary nailing.

Adolescent↗