What's better, internal methods such as the PRECICE nail (
https://www.nuvasive.com/procedures/limb-lengthening/precice-system/ aka an intramedullary nail), or external methods such as Modular Rail System (
https://smith-nephew.com/en-us/health-care-professionals/products/orthopaedics/modular-rail aka LON) , or Taylor Spatial Frames (
https://en.wikipedia.org/wiki/Taylor_Spatial_Frame aka external frames)
Well we have a study for it!
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8706718/n=35, but with 39 procedures
-"Besides the long period of time in the frame, the most frequent adverse effects of external fixators include pin-site infections; implant loosening and frame destabilization; and problems with regeneration, such as premature consolidation, non-union or malunion, limited range of motion (ROM), and joint stiffness "Is this not stuff we've talked about before? But something I hadn't considered was implant loosening and frame destabilization. Ouch! Does anybody here want to give themselves a non-union or a malunion? Probably not. Limited ROM and joint stiffness makes sense, since those frames are
bulky.
-"Using intramedullary growing nails avoids some of these issues, but other serious complications, such as deep infections and the breakage of locking screws and the nail itself, may appear more frequently"But hold on! Look at the studies(there are 4) this point is referencing!
They are using LATN, or the problem has already been fixed, or it simply doesn't apply to us!
Study 1: "We lengthened 9 tibial segments over a nail to reduce the time in the external fixator in 5 patients with constitutional shortness."
See, it's LATN. Which means it
does not apply to the PRECICE nail, a fully internal method.
Study 2: "26 PRECICE nails in 24 patients. 2 nails initially failed to function. Premature consolidation in 1 patient was resolved with a re-osteotomy, classified as a non-implant-associated obstacle. 2 nails broke during the consolidation phase, in 1 case due to a fatigue failure along the welding seam. The other nail broke at the connection between the lengthening unit and the extension rod when the patient fell accidentally."
4 nails had problems,
none of which were infections. Additionally,
this was the first iteration of the PRECICE nail! PRECICE 2.2 resolved all of these problems! Like I mentioned previously, the PRECICE 2.2 nail is the most up to date! It no longer has welding seams, which the first one had. Similarly, "The strength of the PRECICE 2 is up to 4 times stronger than PRECICE 1"! "Furthermore, the driveshaft connection strength has been increased 3 times more than PRECICE 1, which will reduce the risk of nail mechanism failure when a patient produces too much bone, which can result in premature consolidation, which arrests the lengthening process. In short, the PRECICE 2 permits greater lengthening with a stronger nail, a stronger drive shaft..."(Source:
https://paleyinstitute.org/centers-of-excellence/stature-lengthening/the-precice/#/) ! The point is,
these problems have already been resolved.Study 3: "34 posttraumatic limb lengthening patients (femoral: 30, tibial: 4) were included from January 2010 until April 2019."
These are trauma patients, not cosmetic or LLD patients. This study is using the Fitbone, not PRECICE.
"Conclusion: Limb lengthening with a motorized lengthening nail for posttraumatic LLD is a relatively safe and reliable procedure."So what's the deal?
"Compared with idiopathic LLD, posttraumatic patients are more likely to sustain complications when undergoing lengthening surgery due to pre-existing complicating factors, e.g., scare tissue, joint stiffness, dormant infection, skin issues, etc. "Nobody on this forum is a trauma patient. As confirmed by this study, trauma patients are more likely to sustain complications, duh, but we are not trauma patients! Because we are specifically cosmetic patients, why do we care if this does not effect us?
We are cosmetic patients, so why are we so worried about hematomas that trauma patients get? Are lengthening delays something specific to an internal nail? NO. It's a bigger problem with external fixators, as mentioned in the original study. Sepsis? Again, we are not trauma patients with a dormant infection! Screw migration? Once again, our bones were not shattered in a car accident like many of these trauma patients! Where else in the literature is a screw migration this
common!? And are we going to pretend that only internal nails use locking screws?
Study 4: "The Precice intramedullary limb-lengthening system has demonstrated significant benefits over external fixation lengthening methods, leading to a paradigm shift in limb lengthening."
So why is this study pertinent if it repeats what many others have said--Internal nails are better than external fixation?
"Hip and knee ROM was maintained and/or improved following commencement of femoral lengthening in 44 patients (60%) of antegrade nails and 13 patients (38%) of retrograde nails."So hip and knee ROM either got better, or stayed the same, in over
half of the 92 patients? That's pretty good, but does anyone refute the idea that some joint or muscle stiffness is to be expected when lengthening? Is that not why we do PT and stretch? So what's the concern here?
"Minor implant complications included locking bolt migration and in one patient deformity of the nail, but no implant failed to lengthen and there were no deep infections. Three patients had delayed union, five patients required surgical intervention for joint contracture. "Key word: Minor. No implant failed to lengthen, and there were no deep infections? What's the problem? Now I'm not going to downplay 3 delayed unions and 5 joint contractures, that's a risk with all LL, but why are we acting like LON or external frames are any better? Why are we acting like it's unique to the PRECICE nail? It's not.
I'm going to leave the following quote from the study here:
"This study confirms excellent results in femoral lengthening with antegrade and retrograde Precice nails."So we can say that the original problem of "deep infections and the breakage of locking screws and the nail itself, may appear more frequently"
does not or no longer applies to us, except in the most exceptionally rare of cases. But again I ask, is this specific no internal nails?
NO! All surgeries have risk involved, but some methods are safer than others, like using the PRECICE nail over external fixators.
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"The adverse effects of the therapy were observed and analyzed. The highest total rate of problems was noted in the TSF and MRS groups."So NOT the IMN/PRECICE group.
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"At the pin sites of those in these groups, superficial infections were observed in five patients (29%) and two patients (18%), respectively."Superficial, yes, but that shouldn't be ignored. Still, it gets even worse...
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"Moreover, one patient in the TSF group (6%) expressed painful heterotopic intramuscular ossifications in the pin site places."Who would've thought having wires strewn through your leg like some patchwork quilt would hurt...
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"We found obstacles after the application of each method, including delayed consolidation in the IMN group (one patient; 9%), frame destabilization (two patients; 18%) and pre-consolidation (one patient; 9%) in the MRS group, and bone bending (two patients; 12%) in the TSF group."Again, I'm not going to deny that there's risks involved. There are ALWAYS risks with ANY surgery. But I'll take having a delayed consolidation over
bone bending any day! Delayed consolidation is just that, needing more time for the callus to form. But pre-consolidation will require another osteotomy in order to correct and allow lengthening. Which are you choosing?
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"Serious complications were fracture post frame removal (one patient; 9%; Figure 2) and malunion union (one patient; 9%) in the MRS group, two fractures post TSF removal (12%), and hardware failure—broken IMN and regenerate—in one patient (9%; Figure 3)"Now you may read the "hardware failure" with the broken IMN and regenerate and think, "Well, the PRECICE/Internal nails must be far more dangerous!" Well, read further...
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"The patient did not follow the recommendations and went on a hike in mountains and started full weight bearing before the regenerate consolidation"What the F?? Are we going to blame the nail, or the patients stupidity!?
Clearly, the PRECICE nail is far superior to the other two methods!
So all in all we have...
IMN (n = 11)Problems None
Obstacles 1 (9%)—delayed consolidation
Complications 1 (9%)—hardware failure (broken nail and regenerate fracture)
One instance of delayed consolidation, NOT non-union, but just a DELAYED consolidation. I'm not saying that is good, but that is entirely different than a malunion! And a hardware failure which was the fault of the PATIENT, not nail. MRS (n = 11)Problems 2 (18%)—pinsite/superficial infection
Obstacles 2 (18%)—frame Destabilization
1(9%)—pre-consolidation
Complications 1 (9%)—malunion
1 (9%)—fracture post removal
And people argue that LON/Modular Rail System is safe? TSF (n = 17)Problems 5 (29%)—pin site/superficial infection
1 (6%)—heterotopic intramuscular ossifications in pin places
Obstacles 2 (12%)—bone bending
Complications 2 (12%)—fracture post removal
I prefer to not have my bone bend or fracture my newly formed bone right after frame removal. Pin site infections don't sound pleasant either, and painful intramuscular ossifications sound...terrifying. Do you agree?-
"Similarly, Black et al., who analyzed the results of femoral lengthening in skeletally mature children with congenital diseases, indicated a decreased “Category-I” complication rate (pin-track infection and mild joint contractures, which require minimal intervention) in the motorized nail group in comparison to the circular frame group"tldr, internal nails are better than external frames.
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"who combined a monoliteral external fixator with intramedullary nail splinting and compared it with the Ilizarov method"..."Using this combined technique, the other authors confirmed its usefulness in the lengthening of the femur and tibia, although the rate of deep infections remains high, from 2.4% to 15%"LON = 2.4% to 15% of deep infections. No thanks!
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"In our material, superficial pin-site infections were noted in seven cases of external fixators (25%), while deep infections were not observed. The main advantage of TSF over monolateral external fixators is the possibility to correct axial deformations simultaneously with bone distraction. This computer-assisted method is a valuable tool for bone distraction with the correction of complex deformities. So maybe TSF is better than LON if you have a axial deformation? But who cares, we are cosmetic patients!
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"Fracture of the regenerate remains a significant complication of bone lengthening. Four events of fractures occurred: two in the TSF group, one in the MRS group, and one in the IMN group with concomitant nail fracture."Again, the IMN fracture was due to the PATIENT not following the Doctor's instructions, not the nails fault!
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"The evident disadvantages of an external fixator are the presence of a frame, which hinders daily activity and exercise with the need for everyday pin-site cleaning, and a second surgical procedure for hardware removal. In the case of IMN, removal is not obligatory. Additionally, some doubts concern the possibility of magnetic resonance imaging (MRI) subsequently to IMN application. Despite this, it has not been tested for compatibility in the MRI environment and did not receive approval from the Federal Drug Agency (FDA); several studies have tested the safety from this aspect. Gomez et al. did not find negative effects, such as heating, elongation, and migration forces, acting upon this implant in 1.5T and 3T fields [40]. Nevertheless, they concluded that 3T protocols should be avoided in patients who are still undergoing lengthening or if lengthening is planned in the future. "Make of this what you will. Maybe you don't *need* to get the IMN removed, but you probably *should*. I definitely will. There have been anecdotal reports of patients feeling much better after rod removal, for a few reasons. 1) The bone has a certain degree of 'bounce' and 'elasticity' to it, which a nail interrupts. The nail also adds excess weight, making your legs feel heavier. Additionally, the nail causes a stress point at where it's locked, which *could* increase the possibility of fracturing it from other physical activities. Nothing definitive here, but most Doctors are going to recommend you remove the nails, so you probably should.
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"Firstly, the small size of the examined groups is evident. We decided to only include patients with congenital etiology of the femur length deficiency. Post-infected and post-traumatic cases and patients with malignancies were excluded due to adverse influence on the femur lengthening process and the potentially higher frequency of complications."Which again I have to state, we are cosmetic patients, not trauma patients. So this limitation does not apply to us.
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"The second limitation is the retrospective nature of this study and the lack of randomization. However, the compared implants were only available during a certain period (MRS and IMN). The design of the study with the selection of patients who could be treated with all implemented methods assessed in this research can correspond to the randomization."This limitation is hardly a limitation, and doesn't change the outcome anyways. IMN over external fixators.
Conclusion:
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"In conclusion, our study indicates IMN as the most valuable method of treatment for femoral length discrepancy without axial deformity. The strongest advantages were noted in the lowest rate of adverse effects (especially problems and obstacles) and faster regenerate organization with a return to full weight bearing, but a potentially more invasive procedure of hardware removal. We believe that IMNs and TSFs are currently the best options for simple femur bone lengthening in adolescents with congenital disorders. However, there is a need to confirm our findings in a larger group of patients with the randomization protocol. "Do we have axial deformity? NO, we are cosmetic patients. Is hardware removal a factor with LON? YES. Are external fixation, such as LON and External Frames, associated with fracturing the new bone regenerate? YES. Are we adolescents with congenital disorders/axial deformity? NO.
Let's post this quote from the abstract again:
"This study indicates that IMN is a more valuable method of treatment for femoral length discrepancy without axial deformity than MRS and TSF in complication rate and indexes of lengthening and consolidation."Case settled!
The Intra-Medullary Nail/PRECICE is superior to the Modular Rail System/LON and to the Taylor Spatial Frames/external frames.