intramedullary implant
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2021 ◽  
Vol 108 (Supplement_6) ◽  
Author(s):  
R Kamble ◽  
R Mills ◽  
C Williams

Abstract Aim Tension band wiring (TBW) is a popular arthrodesis technique for arthritic hand proximal interphalangeal joints (PIPJs), however often patients struggle with prominent metalwork and require further surgery to remove wires. This study compares outcomes of PIPJ fusion using traditional TBW with the newer Apex intramedullary implant and examines its cost-effectiveness. Method A retrospective analysis of 50 PIPJ fusions was performed in 37 consecutive patients using either TBW or Apex implant at a single unit between January 2013 and March 2020. Clinical and radiographic pre- and post-operative records were reviewed by two independent surgeons. The primary outcome measure was successful fusion of the joint, and complications or further surgery recorded as secondary outcomes. Cost-benefit analysis was performed to determine overall cost of procedure and any subsequent treatments. Results The TBW and Apex groups were comparable as to age, gender, diagnoses, and comorbidities. 27 fusions were performed using TBW compared with 23 fusions using Apex implant. Both cohorts demonstrated 100% union rates. 10 fusions (37%) from TBW group required removal of symptomatic metalwork at a mean 14.7 (± 10.9) months compared to none in the Apex cohort. Conclusions PIPJ fusion using the Apex implant demonstrated equivalent fusion rates to TBW and no additional surgery to remove hardware was required. The Apex implant has an additional cost of £655 (plus loan charge) but given that 37% of TBWs required further removal of metalwork, overall, the Apex implant proved to be cost effective. This study supports the use of the Apex implant as a favourable alternative to TBW.


Author(s):  
Sanjeev Gupta ◽  
Pallav Gupta ◽  
Gagandeep Singh Raina ◽  
Manoj Kumar ◽  
Gagandeep Singh

Background: Proximal femoral nail (PFN) is an intramedullary implant which has been commonly used in the fixation of intertrochanteric fractures. However, controversy comes about the effect of nail length on fracture union and other complications. A comparative evaluation of surgical treatment and functional outcome of patients with peritrochanteric fractures treated with short versus long PFN.Methods:  Total of 100 patients have been included in study out of which 57 belonged to group 1 and were operated with short PFN and rest 43 were group 2 operated with long PFN. Patients were followed up for 6 months and were compared on various parameters.Results: There is no significant difference noted in the two group. However, the surgical duration and blood loss for short PFN was significantly less as compared to long PFN.Conclusions: Short PFN is better implant for peritrochantric fractures both stable and unstable with quicker surgical time and lesser blood loss.


2021 ◽  
Vol 25 (1) ◽  
Author(s):  
Luis Humberto Campos Becerra ◽  
Marco Antonio Loudovic Hernández Rodríguez ◽  
Raúl Lesso Arroyo ◽  
Hugo Esquivel Solís ◽  
Alejandro Torres Castro

Abstract Background The aim of the study is to characterize a biomedical magnesium alloy and highlighting the loss of mechanical integrity due to the sterilization method. Ideally, when using these alloys is to delay the onset of degradation so that the implant can support body loads and avoid toxicological effects due to the release of metal ions into the body. Methods Standardized procedures according to ASTM F-1264 and ISO-10993-5 were used, respecting detailed methodological controls to ensure accuracy and reproducibility of the results, this testing methodology is carried out in accordance with the monographs of the Pharmacopoeia for the approval of medical devices and obtaining a health registration. An intramedullary implant (IIM) manufactured in magnesium (Mg) WE43 can support loads of the body in the initial period of bone consolidation without compromising the integrity of the fractured area. A system with these characteristics would improve morbidity and health costs by avoiding secondary surgical interventions. Results As a property, the fatigue resistance of Mg in aggressive environments such as the body environment undergoes progressive degradation, however, the autoclave sterilization method drastically affects fatigue resistance, as demonstrated in tests carried out under in vitro conditions. Coupled with this phenomenon, the relatively poor biocompatibility of Mg WE43 alloys has limited applications where they can be used due to low acceptance rates from agencies such as the FDA. However, Mg alloy with elements such as yttrium and rare earth elements (REEs) have been shown to delay biodegradation depending on the method of sterilization and the physiological solution used. With different sterilization techniques, it may be possible to keep toxicological effects to a minimum while still ensuring a balance between the integrity of fractured bone and implant degradation time. Therefore, the evaluation of fatigue resistance of WE43 specimens sterilized and tested in immersion conditions (enriched Hank’s solution) and according to ASTM F-1264, along with the morphological, crystallinity, and biocompatibility characterization of the WE43 alloy allows for a comprehensive evaluation of the mechanical and biological properties of WE43. Conclusions These results will support decision-making to generate a change in the current perspective of biomaterials utilized in medical devices (MDs), to be considered by manufacturers and health regulatory agencies. An implant manufactured in WE43 alloy can be used as an intramedullary implant, considering keeping elements such as yttrium-REEs below as specified in its designation and with the help of a coating that allows increasing the life of the implant in vivo.


2021 ◽  
Author(s):  
Luis Humberto Campos Becerra ◽  
Marco Antonio Loudovic Hernández Rodríguez ◽  
Raúl Lesso Arroyo ◽  
Hugo Esquivel S ◽  
Alejandro Torres Castro

Abstract Background: The aim of the study is to characterize a biomedical magnesium alloy and highlighting the loss of mechanical integrity due to the sterilization method. Ideally, when using these alloys is to delay the onset of degradation so that the implant can support body loads and avoid toxicological effects due to the release of metal ions into the body. Methods: Standardized procedures according to ASTM F-1264 and ISO-10993-5 were used, respecting detailed methodological controls to ensure accuracy and reproducibility of the results, this testing methodology is carried out in accordance with the monographs of the Pharmacopoeia for the approval of medical devices and obtaining a health registration. An intramedullary implant (IIM) manufactured in magnesium (Mg) WE43 can support loads of the body in the initial period of bone consolidation without compromising the integrity of the fractured area. A system with these characteristics would improve morbidity and health costs by avoiding secondary surgical interventions. Results: As a property, the fatigue resistance of Mg in aggressive environments such as the body environment undergoes progressive degradation, however, the autoclave sterilization method drastically affects fatigue resistance, as demonstrated in tests carried out under in vitro conditions. Coupled with this phenomenon, the relatively poor biocompatibility of Mg WE43 alloys has limited applications where they can be used due to low acceptance rates from agencies such as the FDA. However, Mg alloy with elements such as yttrium and rare earth elements (REEs) have been shown to delay biodegradation depending on the method of sterilization and the physiological solution used. With different sterilization techniques, it may be possible to keep toxicological effects to a minimum while still ensuring a balance between the integrity of fractured bone and implant degradation time. Therefore, the evaluation of fatigue resistance of WE43 specimens sterilized and tested in immersion conditions (enriched Hank's solution) and according to ASTM F-1264, along with the morphological, crystallinity, and biocompatibility characterization of the WE43 alloy allows for a comprehensive evaluation of the mechanical and biological properties of WE43. Conclusions: These results will support decision-making to generate a change in the current perspective of biomaterials utilized in medical devices (MDs), to be considered by manufacturers and health regulatory agencies. An implant manufactured in WE43 alloy can be used as an intramedullary implant, considering keeping elements such as yttrium-REEs below as specified in its designation and with the help of a coating that allows increasing the life of the implant in vivo.Trial registration: N/A


2020 ◽  
Author(s):  
Luis Humberto Campos Becerra ◽  
Marco Antonio Loudovic Hernández Rodríguez ◽  
Raúl Lesso Arroyo ◽  
Hugo Esquivel S ◽  
Alejandro Torres Castro

Abstract Background: The aim of the study is to characterize a biomedical magnesium alloy and highlighting the loss of mechanical integrity due to the sterilization method. Ideally, when using these alloys is to delay the onset of degradation so that the implant can support body loads and avoid toxicological effects due to the release of metal ions into the body. Methods: The experimentation was carried out according to the standards of ASTM-F-1264 and ISO-10993-5 for mechanical and biological tests respectively, this testing methodology is carried out in accordance with the monographs of the Pharmacopoeia for the approval of medical devices and obtaining a health registration. An intramedullary implant (IIM) manufactured in magnesium (Mg) WE43 can support loads of the body in the initial period of bone consolidation without compromising the integrity of the fractured area. A system with these characteristics would improve morbidity and health costs by avoiding secondary surgical interventions. As a property, the fatigue resistance of Mg in aggressive environments such as the body environment undergoes progressive degradation, however, the autoclave sterilization method drastically affects fatigue resistance, as demonstrated in tests carried out under in vitro conditions. Coupled with this phenomenon, the relatively poor biocompatibility of Mg WE43 alloys has limited applications where they can be used due to low acceptance rates from agencies such as the FDA. However, Mg alloy with elements such as yttrium and rare earth elements (REEs) have been shown to delay biodegradation depending on the method of sterilization and the physiological solution used.Results: With different sterilization techniques, it may be possible to keep toxicological effects to a minimum while still ensuring a balance between the integrity of fractured bone and implant degradation time. Therefore, the evaluation of fatigue resistance of WE43 specimens sterilized and tested in immersion conditions (enriched Hank's solution) and according to ASTM F-1264, along with the morphological, crystallinity, and biocompatibility characterization of the WE43 alloy allows for a comprehensive evaluation of the mechanical and biological properties of WE43. Conclusions: These results will support decision-making to generate a change in the current perspective of biomaterials utilized in medical devices (MDs), to be considered by manufacturers and health regulatory agencies. An implant manufactured in WE43 alloy can be used as an intramedullary implant, considering keeping elements such as yttrium-REEs below as specified in its designation and with the help of a coating that allows increasing the life of the implant in vivo.


Author(s):  
Michel Assad ◽  
Anne Marie Downey ◽  
Caroline Cluzel ◽  
Yannick Trudel ◽  
Nancy Doyle ◽  
...  

Author(s):  
Manthan H. Mandalia ◽  
Hasmukh L. Kubavat ◽  
Nirav Trivedi

<p class="abstract"><strong>Background:</strong> Subtrochanteric fractures are prevalent in young and old age groups and one of the most notorious to achieve a stable fixation which allows early union and mobilization. This was a retrospective study to analyse the outcomes of proximal femur nailing in subtrochanteric fractures and assess the functional outcome, radiological union and compare that with studies of other modalities.</p><p class="abstract"><strong>Methods:</strong> This was a retrospective study of 40 patients with sub trochanteric fractures classified by Sienshiemer classification and operated by proximal femoral nail implant. Clinical evaluation was done by Harris hip score.<strong></strong></p><p class="abstract"><strong>Results:</strong> The average union time in our study was 5.12 months lower than some of the union rates of series with other implants (AO blade plate 7.7%). The conducive environment provided by proximal femoral nail (PFN) allows early mobility, independence to the patient and lessens the complications due to the bed ridden state and decrease the time in returning to work.</p><p class="abstract"><strong>Conclusions:</strong> Our study suggests that PFN being and intramedullary implant gives stable fixation and early union as compared to extramedullary implants with less blood loss and less complications.</p>


2020 ◽  
Vol 28 (2) ◽  
pp. 185-192
Author(s):  
Oliver Pieske ◽  
Maximilian Bauer ◽  
Christian Schröder ◽  
Ina Michaelis ◽  
Felix Massen ◽  
...  

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