This forum is a gold mine for information, but the information density is lacking. It's difficult to sort through the uncontrolled variables, anecdotes, and heresy. So I thought we could all play a game with this specific thread.
I keep hearing that even if you have the most experienced surgeon and are the most compliant patient, there's still risks associated to LL.
Let's assume you have the "best" surgeons, and you are extremely compliant as a patient. As someone who wants to go into this with eyes wide open, I want to thoroughly uncover the remaining risks with everyone.
Rules- Only post or reply if you can reference a trusted source, which includes studies, research papers, or direct quotes from doctors/surgeon. It does not include patient experiences from patients with unvetted surgeons. The last piece may seem discriminatory, but there are way too many things that can go wrong with an inexperienced surgeon. I'll arbitrarily set "vetted" as appearing in an interview with Cyborg4Life's channel (you tube.com/c/Cyborg4Life).
- Include a link and direct quote or paraphrase that reference in your reply.
- Make a clear distinction between your opinion and the information that comes from a reputed source.
I'll keep posting until I get bored.
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Reference:
https://paleyinstitute.org/centers-of-excellence/stature-lengthening/complications/#/Fat Embolism - Very rare, can cause death, can be prevented.
Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE) - Rare, preventable with anticoagulants, DVT can lead to PE, which can cause shortness of breath, chest pain and even death. Taking oral contraceptives and smoking increases the risk of DVT.
Premature Consolidation - rare, prevents further lengthening, re-break is necessary for further lengthening
The only way to prevent this is to speed up the lengthening intentionally for a week or two.
Delayed or Failure of Consolidation - preventable by identifying and addressing risk factors, sing surgical methods, setting proper rate of distraction, or reversing distraction; delays weight bearing and increase the period of disability and recovery; can require more surgery to induce bone healing which is expensive.
Nerve Injury - uncommon if the rate of distraction does not exceed 1mm per day and if the amount of lengthening is restricted; Recognition of nerve symptoms is important. The lengthening should be stopped or slowed in such cases;
Muscle Contractures - preventable with PT and patient should do their own stretches at home several times per day. A fixed contracture of the knee or ankle can lead to disability and the need for more prolonged PT along with associated expenses.
Fibular Complications - preventable with surgeon's technique
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My notes --
Fat Embolism - appear not to be a risk given the assumptions i.e. "best" surgeon.
Fibular complications - appear not to be a risk given the assumptions i.e. "best" surgeon.
Muscle Contractures - unclear whether it's still a risk given the assumptions i.e. compliant patient.
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Reference:
http://www.limblengtheningforum.com/index.php?topic=9104.465MyEvolution documents a case of premature consolidation. He underwent the process with the Paley Institute.
Reference:
http://www.limblengtheningforum.com/index.php?topic=9104.527Paid ~20k USD for re-breaking.
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Reference:
https://www.hindawi.com/journals/bmri/2017/8032510/Some studies show an alarming rate of device-related complications for PRECICE 1 vs PRECICE 2, 17.6% (6/34), and 50% (23/46) respectively.
Nail bending and breakage of rotation coupling without actual instability was the biggest complication. Seen mostly in the smallest (8.5 diameter) nail.
This does not include PRECICE 2.3.
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Reference:
https://www.tandfonline.com/doi/full/10.1080/17453674.2021.1903278Serious adverse events during treatment with the Precice Stryde.
Late onset of pain was a prominent feature in 8/27 patients.
In the MHRA reference 2020/012/009/226/001 issued January 20, 2021 one concern that was raised was the “unknown long-term biological safety profile. This includes reports of pain and bony abnormalities at the interface between the telescoping nail segments.”
2/30 femoral Stryde nails broke within 1 year after implantation (nail diameter: Ø11.5, Ø11.5; patient weight: 55 kg, 85 kg). This adverse event is not considered to be related to the described osteolysis, but a consequence of regenerate insufficiency
If the suspected prodrome—late onset of pain in the junctional area—is included, 23/30 of segments were affected. Despite these alarming numbers, the true incidence rate is likely to be higher, as 15/30 of the bone segments were still at risk, i.e., the nails were not removed at the time of writing.
In contrast, Robbins and Paley (2020
https://www.tandfonline.com/doi/full/10.1080/17453674.2021.1903278#), who were the first to implant the device in May 2018, state in their paper from 2020 evaluating 187 lengthened bone segments in 106 patients: “There were no issues related to biological incompatibility of the Biodur® 108 alloy stainless steel from which the implant was fabricated. There was no corrosion seen in the few nails that were removed during this short study time.”
2 patient were suddenly unable to fully weight-bear after solid consolidation of the regenerate
Vogt et al. (2021) also describe osteolysis in Stryde nails. Late onset of pain was also the dominant clinical feature in their case series, which was relieved by hardware removal. Moreover, they observed discoloration of the nail at the telescoping interface.
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My notes --
On the plus side, it seems removing the hardware relieves pain.
Author
Topic: PRECICE studies, risks, & complications (Read 1364 times)