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"Bone Nails"
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The IlluminOss® photodynamic bone stabilization system for pathological osteolyses and fractures of the humerus: indications, advantages and limits in a series of 12 patients at 24 months of minimum follow‐up
by
Attala, Dario
,
di Uccio, Alessandra Scotto
,
Pugliese, Mattia
in
Bone implants
,
Bone lesions
,
Bone metastasis
2021
Background
Locked titanium nails are considered the reference treatment for metastatic bone lesions of the humerus in patients with aggressive histotypes, high risk of fracture or when estimated survival is lower than 6 months.Nevertheless, they are responsible for CT and MRI artifacts which interfere with postoperative radiotherapy and follow-up.The IlluminOss® is an intramedullary stabilization system which is introduced inside the humeral canal in a deflated state, and is then distended with a monomer which hardens after exposure to blue light,stabilizing the segment; it does not cause artifacts, allowing easier and more effective radiotherapy and follow-up.
The aim of this study is to report our experience, indications, possible advantages and limitations of this stabilization system at 24 months of minimum follow-up in a series of 12 patients affected by pathological fractures or impending fractures of the humerus.
Methods
This is a retrospective case-series that included all patients who underwent surgery with the IlluminOss® Photodynamic Bone Stabilization System for pathological osteolyses and fractures of the humerus. Intraoperative and postoperative complications were valued.
Results
12 patients and 13 procedures were included in the study. All surgeries were performed without intraoperative complications. No early postoperative complications were noted. The wounds healed in all cases and stitches were removed at two weeks from surgery, so the patients were able to perform chemotherapy after three weeks. All patients except one had a painless active range of motion which reached 90°.The VAS score was 7 preoperatively and 2.6 at one month from surgery. Pain relief was also associated to radiotherapy and chemotherapy.
Unfortunately, two nail ruptures were reported at 4 and 12 months of follow-up.
No artifacts were noted in the postoperative CT scans so the radiotherapy plans were easily performed without the need of dose compensation.
Conclusions
The IlluminOss® intramedullary stabilization system can provide primary stability in humeral fractures and impending fractures;the surgical technique is easy and minimally invasive.Moreover,it does not present artifacts at postoperative imaging,probably giving a better chance to perform prompt radiotherapy and chemotherapy.However, randomized clinical studies are necessary to verify its potential strength and if precocious adjuvant radio- and chemotherapy are associated to a reduction of the local progression rate.
Journal Article
Intramedullary Nailing vs Sliding Hip Screw in Trochanteric Fracture Management: The INSITE Randomized Clinical Trial
by
Garcia, Julio C
,
Stengel, Dirk
,
Investigators, INSITE
in
Clinical trials
,
Patients
,
Quality of life
2023
Importance Fractures of the hip have devastating effects on function and quality of life. Intramedullary nails (IMN) are the dominant implant choice for the treatment of trochanteric fractures of the hip. Higher costs of IMNs and inconclusive benefit in comparison with sliding hip screws (SHSs) convey the need for definitive evidence. Objective To compare 1-year outcomes of patients with trochanteric fractures treated with the IMN vs an SHS. Design, Setting, and Participants This randomized clinical trial was conducted at 25 international sites across 12 countries. Participants included ambulatory patients aged 18 years and older with low-energy trochanteric (AO Foundation and Orthopaedic Trauma Association [AO/OTA] type 31-A1 or 31-A2) fractures. Patient recruitment occurred between January 2012 and January 2016, and patients were followed up for 52 weeks (primary end point). Follow-up was completed in January 2017. The analysis was performed in July 2018 and confirmed in January 2022. Interventions Surgical fixation with a Gamma3 IMN or an SHS. Main Outcomes and Measures The primary outcome was health-related quality of life (HRQOL), measured by the EuroQol–5 Dimension (EQ5D) at 1-year postsurgery. Secondary outcomes included revision surgical procedure, fracture healing, adverse events, patient mobility (measured by the Parker mobility score), and hip function (measured by the Harris hip score). Results In this randomized clinical trial, 850 patients were randomized (mean [range] age, 78.5 [18-102] years; 549 [64.6% female) with trochanteric fractures to undergo fixation with either the IMN (n = 423) or an SHS (n = 427). A total of 621 patients completed follow-up at 1 year postsurgery (304 treated with the IMN [71.9%], 317 treated with an SHS [74.2%]). There were no significant differences between groups in EQ5D scores (mean difference, 0.02 points; 95% CI, −0.03 to 0.07 points;P = .42). Furthermore, after adjusting for relevant covariables, there were no between-group differences in EQ5D scores (regression coefficient, 0.00; 95% CI, −0.04 to 0.05;P = .81). There were no between-group differences for any secondary outcomes. There were also no significant interactions for fracture stability (β [SE] , 0.01 [0.05];P = .82) or previous fracture (β [SE], 0.01 [0.10];P = .88) and treatment group. Conclusions and Relevance This randomized clinical trial found that IMNs for the treatment of trochanteric fractures had similar 1-year outcomes compared with SHSs. These results suggest that the SHS is an acceptable lower-cost alternative for trochanteric fractures of the hip. Trial Registration ClinicalTrials.gov Identifier:NCT01380444
Journal Article
Locking nail versus locking plate for proximal humeral fracture fixation in an elderly population: a prospective randomised controlled trial
by
Seebauer, Tobias
,
Holz, Rainer
,
Henderson, Daniel J. H.
in
Arthritis
,
Biomechanics
,
Care and treatment
2019
Background
Proximal humeral fractures (PHFs) are the third most common fracture in older patients. The purpose of the study was to prospectively evaluate the outcomes of PHF fixation with a locking blade nail (LBN) or locking plate (PHILOS) osteosynthesis in a homogeneous elderly patient population.
Methods
Inclusion criteria were an age > 60 years and the capacity to give informed consent. Patients with isolated tuberosity fractures, previous trauma or surgery, advanced osteoarthritis, fracture dislocation, pathological fractures, open fractures, neurological disorders, full-thickness rotator cuff tears, fracture line at the nail entry point or severely reduced bone quality intra-operatively were excluded.
Eighty one patients with PHFs were randomised to treatment using LBN or PHILOS. Outcome measures comprised Constant score, age and gender adjusted Constant score, DASH score, VAS for pain, subjective overall condition of the shoulder (1–6) and active shoulder range-of-motion in flexion and abduction. Plain radiographs were obtained in two planes. All data were collected by an independent observer at 3, 6 and 12 months postoperatively.
Results
Thirteen patients were excluded intra-operatively due to rotator cuff tears, fracture morphology or poor bone-quality. Of the remaining 68 patients, 27 in the LBN and 28 in the PHILOS group completed the full follow-up. Mean age at surgery was 75.6 years and the majority of PHFs were three-part fractures (49 patients). Baseline demographics between groups were comparable.
All outcome measures improved between assessments (
p
< 0.001). The LBN group showed improved DASH scores as compared to PHILOS at 12 months (
p
= 0.042) with fewer incidences of secondary loss of reduction and screw cut-out (
p
= 0.039). A total of 29 complications (in 23 patients) were recorded, 13 complications (in 12 patients) in the LBN group and 16 complications (in 11 patients) in the PHILOS group (
p
= 0.941). No significant inter-group difference was observed for any other outcome measures, nor was fracture morphology seen to be associated with clinical outcome or complication rate.
Conclusions
At short-term follow-up, LBN osteosynthesis yielded similar outcomes and complication rates to PHILOS plate fracture fixation in an elderly patient population, though with a significantly lower rate of secondary loss of reduction and screw cut-out.
Registration trial
No. DRKS00015245 at Deutsches Register Klinischer Studien, registered: 22.08.2018, retrospectively registered.
Journal Article
Risk factors for implant failure in reverse oblique and transverse intertrochanteric fractures treated with proximal femoral nail antirotation (PFNA)
Background
The incidence of intertrochanteric hip fracture is expected to increase as the global population ages. It is one of the most important causes of mortality and morbidities in the geriatric population. The incidence of reverse oblique and transverse intertrochanteric (AO/OTA 31-A3) fractures is relatively low; however, the incidence of implant failure in AO/OTA 31-A3 fractures is relatively high compared with that in AO/OTA 31-A1 and A2 fractures. To date, the risk factors for implant failure in AO/OTA 31-A3 fractures treated with proximal femoral nail antirotation (PFNA) have remained ambiguous. The purpose of this study was to identify the predictive factors of implant failure in AO/OTA 31-A3 fractures treated with PFNA.
Methods
The data of all patients who underwent surgery for trochanteric fractures at our institution between January 2006 and February 2018 were retrospectively reviewed. All AO/OTA 31-A3 fractures treated with PFNA were included. Logistic regression analysis of potential predictors of implant failure was performed. Potential predictors included age, sex, body mass index, fracture type, reduction method, status of posteromedial support and lateral femoral wall, reduction quality, tip-apex distance and position of the helical blade in the femoral head.
Results
One hundred four (9.3%) patients with AO/OTA 31-A3 fractures were identified. Forty-five patients with AO/OTA 31-A3 fractures treated with PFNA were suitable for our study. Overall, implant failure occurred in six (13.3%) of forty-five patients. Multivariate analysis identified poor reduction quality (OR, 28.70; 95% CI, 1.91–431.88;
p
= 0.015) and loss of posteromedial support (OR, 18.98; 95% CI, 1.40–257.08;
p
= 0.027) as factors associated with implant failure.
Conclusions
Poor reduction quality and loss of posteromedial support are predictors of implant failure in reverse oblique and transverse intertrochanteric fractures treated with PFNA.
Journal Article
Surgical fixation of displaced midshaft clavicle fractures: elastic intramedullary nailing versus precontoured plating
by
Narsaria, Nidhi
,
Seth, R. R. S.
,
Singh, Ashutosh K.
in
Adult
,
Aged
,
Bone Nails - adverse effects
2014
Background
This prospective comparative study was done to evaluate the effectiveness of implants of different design (titanium elastic intramedullary nail versus anatomical precontoured dynamic compression plate) in treatment of displaced midshaft clavicular fractures.
Materials and methods
Sixty-six patients between 18 and 65 years of age were included in this study. They were randomized in two groups to be treated with either elastic intramedullary nail (EIN) or plate. Clinical and radiological assessments were performed at regular intervals. Outcomes and complications of both groups over 2 years of follow-up time were compared.
Results
Length of incision, operation time, blood loss and duration of hospital stay were significantly less for the EIN group. American Shoulder and Elbow Surgeons (ASES) and Constant Shoulder scores were significantly higher (
p
< 0.05) in the plating group than the EIN group for the first 2 months but there was no significant difference found between the two groups regarding functional and radiological outcome at the 2-year follow-up. Significantly higher rates of refracture after implant removal (
p
= 0.045) in the plating group was observed. Infection and revision surgery rates were also higher in the plate group, but this difference was insignificant (
p
> 0.05).
Conclusions
EIN is a safe, minimally invasive surgical technique with a lower complication rate, faster return to daily activities, excellent cosmetic and comparable functional results, and can be used as an equally effective alternative to plate fixation in displaced midshaft clavicle fractures.
Level of evidence
Level 2.
Journal Article
Elastic stable intramedullary nailing in paediatric diaphyseal forearm fractures – a retrospective analysis of 201 cases
2024
Background
Forearm shaft fractures are common injuries, often caused by falling from a fully-upright position or falling off a bike. They can be treated nonoperatively or surgically with intramedullary nailing or plates. The method of choice for treating pediatric forearm shaft fractures is the application of elastic stable intramedullary nailing (ESIN)|. The aim of the study was to evaluate ESIN in pediatric patients with forearm shaft fractures based on radiological images, and determine the etiology and complication rate associated with the injury.
Methods
The study included 201 patients, 30.5% female 69.5% male, aged 1 to 17 years (mean 9.1 years; SD = 3.2), all had been diagnosed with a fracture of the forearm shaft and had been treated surgically with ESIN. In addition, all possessed a complete set of X-ray images and had attended a minimum six-month follow-up examination of the forearm. Axial alignment was evaluated retrospectively in the anatomical (AP) and lateral (LAT) positions. In total, 402 radiographs were examined. Of the injuries, 68% occurred during sports activity and 75% involved both the radius and the ulna.
Results
Union was observed in all cases. Mean axial alignment values in AP and LAT X-ray or both the ulna and radius were satisfactory. Axial alignment values were not influenced significantly by age, type of surgery, type of fracture or etiology. Plaster cast application (9.8% of cases) significantly influenced radius axial alignment. The complication rate was 11.4% (
n
= 23). Significantly more complications were observed in patients receiving open reduction internal fixation (ORIF) (
p
= 0.0025).
Conclusion
The ESIN technique is an effective treatment for forearm diaphyseal fractures in children, with good results regarding reduction and bone healing, indicated by x-ray.
Journal Article
Pin-tract infection is an important factor associated with pin loosening during external fixation: a prospective analysis of 47 consecutive patients
2025
The occurrence of pin loosening represents a common issue in the context of external fixation methodologies; nevertheless, a comprehensive investigation into the multifaceted causes of pin loosening, incorporating a multivariate analysis among pin infection, bone quality, and pin insertion angle, is notably absent in current literature. The present study endeavors to pinpoint factors associated with pin loosening through such a multivariate analysis.
The study encompassed patients who underwent the removal of external fixators from March 2023 to July 2023. The assessment of pin loosening was executed through the utilization of the pin track score, the pin removal torque value (PRTV), and the radiolucent zone around the pin (RZAP) as depicted in digital radiography (DR) images. Culturing of the pin-bone interfaces was performed, and measurements of the grayscale intensity of cortical bone (GSCB) and pin verticality within DR images were taken. Multivariate analyses were conducted employing a Generalized Linear Mixed-Effects Model (GLMM), Adjusted odds ratios (aORs) with 95% confidence intervals (CIs) were calculated by exponentiating the model coefficients (Exp(β)).
Altogether 47 patients with a total of 220 pins were included for analysis. The mean PRTV was 1.9 ± 2.1 N·m. The correlation analysis between PRTV and RZAP yielded a
-value of less than 0.001, signifying a substantial correlation between pin loosening and RZAP. For pins with a PRTV of 0, the RZAP measured 1.9 ± 0.8 mm. The positive rate of bacterial culture was 20%, and the loosening rate was 26.8%. Pin loosening was significantly associated with bacterial infection (aOR = 2.24, 95% CI: 1.03-4.90,
= 0.04) and GSCB (aOR = 0.50, 95% CI: 0.38-0.66,
< 0.01), but not with pin verticality (aOR = 1.00, 95% CI: 0.93-1.08,
= 0.99). Non-HA-coated pins remained significantly associated with bacterial infection (aOR = 8.20, 95% CI: 2.18-30.85,
= 0.002), whereas HA-coated pins were not (aOR = 3.44, 95% CI: 0.24-48.76,
= 0.36).
Pin loosening was significantly associated with bacterial infection at the pin-bone interface and lower GSCB, but not with pin verticality. Notably, infection strongly predicted loosening in non-HA-coated pins, while HA-coated pins demonstrated higher raw infection rates.
Journal Article
Intramedullary nail holes laser indicator, a non-invasive technique for interlocking of intramedullary nails
2021
Interlocking of intramedullary nails is a challenging procedure in orthopedic trauma surgery. Numerous methods have been described to facilitate this process. But they are exposed patient and surgical team to X-rays or involves trial and error. An accurate and non-invasive method has been provided to easily interlocking intramedullary nails. By transferring a safe visible light inside the nail, a drilling position appears which use to drilling bone toward the nail hole. The wavelength of this light was obtained from ex-vivo spectroscopy on biological tissues which has optimal transmission, reflectance, and absorption properties. Moreover, animal and human experiments were performed to evaluate performance of the proposed system. Ex-vivo performance experiments were performed successfully on two groups of cow and sheep samples. Output parameters were procedure time and drilling quality which there were significant differences between the two groups in procedure time (P < 0.05). But no significant differences were observed in drilling quality (P > 0.05). Moreover, an In-vivo performance experiment was performed successfully on a middle-aged man. To compare the provided method, targeting-arm, and free-hand techniques, two human experiments were performed on a middle-aged and a young man. The results indicate the advantage of the proposed technique in the procedure time (P < 0.05), while the drilling quality is equal to the free-hand technique (P = 0.05). Intramedullary nail holes laser indicator is a safe and accurate method that reduced surgical time and simplifies the process. This new technology makes it easier to interlocking the intramedullary nail which can have good clinical applications.
Journal Article
Management of pin tract infection in pediatric supracondylar humerus fractures: a comparative study of three methods
2017
The objective of this study was to prospectively compare the incidence of pin tract infection in pediatric supracondylar humerus fractures managed with pin care daily or every other day or weekly. We hypothesized that there were some differences between these three methods. From June 2012 to May 2015, 135 children with supracondylar humerus fractures were randomized to postoperative pin care by cleaning pin tracts daily (group A, 45 cases) or cleaning every 2 days (group B, 45 cases) or cleaning weekly (group C, 45 cases). The three groups were comparable with respect to age, gender, affected side, body mass index (BMI), fracture type, injury to surgery time, number of intraoperative percutaneous pinning, and follow-up time. We collected data on pin retention time, union time, and pin tract infection. The average follow-up time of group A was 4.5 ± 1.3 and 4.2 ± 1.6 months in group B and 4.3 ± 1.4 months in group C. The patient demographics and intraoperative variables of three groups were comparable. No significant difference between these three groups was found in union time and pin fixation time. Of the 135 children, 48 (35.6%) cases had pin tract infection. Grade I infections (Checketts-Otterburns classification) occurred around 28.9% of 270 pin and grade II around 6.7%. We found no differences between three groups as regards frequency and severity of pin tract infections (both
P
> 0.05). However, complain of pain was more frequent in group A than other two groups (
P
< 0.05).
Conclusions
: All of the three methods were effective for the management of pin site infection in pediatric supracondylar humerus fractures. However, excessive frequent care as well as pin care daily had the disadvantages of child’s fear and parental anxiety.
What is Known:
•
Pin
site infection is a common complication after fracture fixation and bone lengthening using percutaneous pins or wires.
•
Closed reduction and percutaneous K-wires fixation are the mainstay of treatment in pediatric supracondylar humeral fractures.
What is New:
•
All of the three methods were effective for the management of pin site infection.
•
Excessive frequent care as well as pin care daily has the disadvantages of child’s fear and parental anxiety.
Journal Article
Operative treatment of 2-part surgical neck fractures of the proximal humerus (AO 11-A3) in the elderly: Cement augmented locking plate Philos™ vs. proximal humerus nail MultiLoc
by
Böcker, Wolfgang
,
Ockert, Ben
,
Haasters, Florian
in
Aged
,
Aged, 80 and over
,
Bone Cements - adverse effects
2016
Background
Proximal humeral fractures are with an incidence of 4–5 % the third most common fractures in the elderly. In 20 % of humeral fractures there is an indication for surgical treatment according to the modified Neer-Criteria. A secondary varus dislocation of the head fragment and cutting-out are the most common complications of angle stable locking plates in AO11-A3 fractures of the elderly. One possibility to increase the stability of the screw-bone-interface is the cement augmentation of the screw tips. A second is the use of a multiplanar angle stablentramedullary nail that might provide better biomechanical properties after fixation of 2-part-fractures. A comparison of these two treatment options augmented locking plate versus multiplanar angle stable locking nail in 2-part surgical neck fractures of the proximal humerus has not been carried out up to now.
Methods/Design
Forty patients (female/male, ≥60 years or female postmenopausal) with a 2-part-fracture of the proximal humerus (AO type 11-A3) will be randomized to either to augmented plate fixation group (PhilosAugment) or to multiplanar intramedullary nail group (MultiLoc). Outcome parameters are Disabilities of the Shoulder, Arm and Hand-Score (DASH) Constant Score (CS), American Shoulder and Elbow Score (ASES), Oxford Shoulder Score (OSS), Range of motion (ROM) and Short Form 36 (SF-36) after 3 weeks, 6 weeks, 3 months, 6 months, 12 and 24 months.
Discussion
Because of the lack of clinical studies that compare cement augmented locking plates with multiplanar humeral nail systems after 2-part surgical neck fractures of the proximal humerus, the decision of surgical method currently depends only on surgeons preference. Because only a randomized clinical trial (RCT) can sufficiently answer the question if one treatment option provides advantages compared to the other method we are planning to perform a RCT.
Trial registration
Clinical Trial (
NCT02609906
), November 18, 2015, registered retrospectively.
Journal Article