Akademik Veri Yönetim Sistemi
TÜBİTAK Projesi, 2014 - 2014
The first limb lengthening was tried by Codivilla with his primitive device at the begining of the 20 th centruy(1). At the1950s Dr Ilizarov et all explained the distraction osteogenesis and its biology. Althougth that it was possible treat many untreatable conditions likes congenital anomalies , infection and defect pseudoarthrosis but high complication rates were the main handicap for external fixators (7-11) Pin-tract infections, deep infection, neurovascular injuries, prolonged treatment time, muscular and soft-tissue transfixation that lead to contractures and stiffness, pain and discomfort, refracture and, psychosocial burden were the main complications (7-13).
Lengthening with internal device with the principle of distraction osteogenesis was first described by Alexander Bliskunov from Sinferopel, Ukraine in 1983 (13,20). Baumgart and Betz from Germany developed a motorized nail in 1991 (now called Fitbone). The Fitbone (Wittenstein, Igersheim, Germany) is a fully implantable lengthening nail whose mechanism is driven by an internal motor that requires an external transmitter. An antenna comes out of one end of the nail and is implanted subcutaneously. It is powered and controlled by radiofrequency and the lengthening is performed at night when the patient is in bed to mimic natural growth. Need for grafting, reoperation because of motor problems,lack of strongness to provide distraction and need to permission to use it ( from Dr Baumgart or the Wittenstein company) were the main difficulties. Guichet and Grammont from France, developed a telescopic nail in 1994 using a ratchet mechanism which rotated 20 degrees the 2 segments of the nail through the osteotomy and callus of the distraction gap. The Gradual Lengthening Nail also known as Albizzia (Depuy, Villerbuane, France) was later modified and released as the Betzbone and the Guichet nail.Many reports exist of patients suffering from severe pain and discomfort, which limit their ability to independently perform the lengthenings. In some cases, these patients required readmission to the hospital with general anesthesia and closed manipulation. (24–26) Using the same concept of lengthening by rotation through the callus, Cole developed a double-clutch mechanism to cause distraction. Only 3 to 9 degrees of rotation was required to cause the nail to lengthen. The intramedullary Skeletal Kinetic Distractor (ISKD) (Orthofix Inc., McKinney, TX) as the lengthening was so easy to activate, it was causing rapid lengthening, referred to as run away lengthening. İt was causing not only the pain but was a big danger for neurovasculair structures which could be damaged in more than 1 to 1,5 mm /day lengthening. Nail was working in one way it means that it was not possible to shorten the distraction side which could be used in standart external fixators to deal with over lengthening and lack of consolidation(27–30)
Arnaud Soubieran from France developed the Phenix. By rotating the magnet around the leg an internal crankshaft mechanism in the nail was rotated. This lead to traction on a wire pulley, which caused distraction of the nail. The mechanism for the Phenix was first used in a spinal distractor, and, in a lengthening prosthesis manufactured by the same company. Rotating the magnet one direction leads to lengthening, whereas rotating it the other way leads to shortening. nail. Ellipse Technologies (Ellipse Technologies, Irvine, CA) developed the Precice nail with a team of surgeons headed by Dr Stuart Green. Ellipse used the same mechanism that they had developed for their spinal growing rod called “the MAGEC System. The gears are connected to a coupling, which is connected to a threaded drive shaft. The mechanism is activated by an external remote control (ERC) device. The ERC employs 2 motor-driven rotating. magnets to magnetically couple to and rotate the magnetic metal pins. The ERC performs 30 revolutions per minute. It takes 7 minutes and 210 revolutions to achieve 1mm of lengthening. Facing the ERC 1 direction causes the nail to lengthen, whereas facing it the other direction would go in the reverse (shortening) direction. The Precice is the second FDAcleared implantable lengthening nail device (July 2011) and the first one to have bidirectional control (lengthening and shortening). The same company developed the Precice 2 with Dror Paley and released this nail in Nov 2013
Operative technique:
Preoperative planning is important before surgery to determine the ideal nail length, insertion point (eg, trochanteric vs. piriformis), osteotomy level, and direction of the nail (antegrade vs. retrograde). The nail length and osteotomy level are very interrelated. To avoid friction the osteotomy level is planned to leave 1 to 3 cm of the wider tube of the nail engaged in the opposite segment of the bone. When there is a larger femoral bow it is prefered to make the osteotomy at the level of the apex of the bow. Working backwards this can help calculate the ideal length of the nail to use. In most cases a relatively short nail is used compared with nailing for fixation of fractures. The femur can be reamed with flexible or straight rigid reamers. The latter are less available and less forgiving. However, they conform to the shape of the nail better and are preferred if available. Piriformis start is preferred in most adult femurs unless there is a coxa breva or valga. In children with open proximal femoral physes, a trochanteric start point is preferred to minimize the risk of avascular necrosis. Retrograde nailing is used in the femur in conjunction with angular deformity correction of the distal femur or if there is a quadriceps lag that needs to be tightened (1 case in the series below had retrograde nailing for the quadriceps lag). Retrograde tibial nailing is used in patients with pantalar arthrodesis.
To be considered eligible for treatment, patients needed to possess a limb leg discrepancy of at least 1.5 cm, or desire to undergo a cosmetic lengthening. Patients were offered internal lengthening with the Precice as long as the diameter of the canal and length of the bone in question was large enough to safely accommodate the implant, there was no evidence of active infection, and there were no associated deformities that precluded its use. They also needed to be capable of undergoing daily physical therapy.
In our study we compared the radiological and clinical results of precice 1 and precice 2 nails with the complications. Institutional Review Board approval was obtained for this study.
Methodology :
study is planned in two groups; group 1 was the precice nail 1. Between 2010 and 2013, 118 extremities of 76 patients were lengthened with precice 1 nail. The mean age was 24,5 ( range ;10-55) years. 54 of the cases were congenital shortening. 24 nail was used for tibia lengthening , 1 nail was used for fibula lengthening, 93 nail was used for femur lengthening. Piriformis entry in 53, trochanteric entry in 37 and retrograde entry in 3 patients for Femur lengthening.
group 2 was the precice nail 2. Between 2013 and september 2014, 104 extremities of 61 patients were lengthened with precice 2 nail. The mean age was 21,3 ( range ;6-45) years. 39 of the cases were congenital shortening. 14 nail was used for tibia lengthening , 90 nail was used for femur lengthening. Piriformis entry in 53, trochanteric entry in 36 and retrograde entry in 1 patients for Femur lengthening. Lengthening amount, lengthening time, consolidation time, complication rate and the valgisation that occur uring the intramedullary nail lengthening is calculated from the preoperative and postoperative x rays. Mechanical axe deviation (MAD) lateral distal femoral angle(LDFA), medial proximal tibial angle (MPTA) ,medial proximal femoral angle (MPFA), posterior distal femoral angle(PDFA),lateral distal tibial angle(LDTA), posterior proximal tibial angle (PPTA) and anterior distal tibial angle (ADTA) were mesured and compared between the 2 group and also in the same group with preoperative and post operative values. Mann whitney U test and student T test are used for the statistical evaluation .P value of <0,05 is considered as significant
I. And II. Term: COLLECTİON OF THE İNFORMATİON OF THE PATİENTS, PARTİCİPATİON TO THE OPERATİON OF THE PRECİCE 2
III. Term: EVALUATİON OF THE DATA AND THE STUDY
Preoperative the mean goal of lengthening was 5 cm ( range 7-1,5) in group 1 and 5,9 cm in group 2. İn group 1 the preoperative MAD was 1,35 mm and postoperative MAD was -2,6. İn group 2 the preoperative MAD was 2,7 mm and postoperative MAD was 1,1mm. Other parametric results are given in table 1
TABLE :1
preop | at end | preop | at end | preop | at end | preop | at end | preop | at end | preop | at end | |
mean values | mLDFA | mLDFA | mLPFA | mLPFA | mMPTA | mMPTA | mLDTA | mLDTA | aPPTA | aPPTA | aADTA | aADTA |
group 1 | 88 | 87,5 | 89,3 | 90,8 | 88,8 | 91 | 88,9 | 86,6 | 83,9 | 80,9 | 86 | 87,3 |
group2 | 87,6 | 87,9 | 88,6 | 89,9 | 89,5 | 89,6 | 86,8 | 89,7 | 78,7 | 78,9 | 87,6 | 86 |
İn group 1 the mean lengthening was 5 cm and the mean distraction day was 65.in group two the mean lengthening was 5,8 cm and mean distraction day was 74,6 days. there is no differance between these two group both in parametric values in table 1 and distraction days (p>0,05)
The differance between the two group is the complication rates. The bending of the nail and the nail fractures are much more in group 1 than in group2. İn group 1 there is 4 broken nail and 4 bended nail (less than 8 degree) in group 2 there is just 1 broken nail and 2 bended nail. There is 2 infection in both group.
The goals of implantable distraction nails are to avoid many of the known complications of external fixators while making the process of lengthening more predictable and beter tolerated by the patients. Some of the previously designed lengthening nails were fraught with complications. Poor regenerate, difficulty in distraction, mechanical failure of the implants and valgus deformity at the femur lengthenings are the main disadvantages of the internal lengthening devices.
Althougth that there is no statistical differance between the two group. The mean lengthening amount in the group 2 is more than group1. The main complication about the lengthening are seen after the 5 cm lengthening of the extremities. İn group 1 the mean lengthening amount is 5 cm and in group 2 the mean lengthening is 5,8cm. it means, althougth that surgeons are challenged more in the second group with precice 2, the complication rates are much less with precice 2. İnfact for both groups the rate of complications are much less than what we were used to see during the lengthening case with external fixators.
The future for noninvasively adjusted limb lengthening devices is very exciting. Future innovation will likely producea bone transport nail to treat bone defects, limb lengthening plate for children with open growth plates, and gradual deformity correction plates. Miniaturization and new mechanisms will allow greater application of such technology. Adjustable nails could eventually replace simple locking nails for trauma, allowing adjustability of length postoperatively.
Lengthening with internal device with the principle of distraction osteogenesis, seems as the future. Nails should be more resistable to tolerate weigth bearing, smaller as diameter and shorter for the congenital cases. These are the new callenges.