Background - Growth guidance sliding treatment devices, such as Shilla (Medtronic, Minneapolis, MN USA) or LSZ-4D (CONMET, Moscow, Russia), used for the treatment of scoliosis in children who have high growth potential have unlocked fixtures that allow rods to slide during growth of the spine, which avoids periodical extensions. However, the probability of clinical complications associated with metallosis after implantation of such devices is poorly understood. The content of metal ions in the blood and tissues of pediatric patients treated for scoliosis using fusionless growth guidance sliding instrumentation has not yet been investigated.
Purpose - The aim of the present study was to measure the content of metal ions in the blood and tissues surrounding the implanted growth guidance sliding LSZ-4D devices made of titanium alloy (Ti6Al4V), and to identify the incidence of metallosis-associated clinical complications in some patients with these devices.
Study Design - This is a one-center, case-control retrospective study.
Patients Sample - The study group included 25 patients with high growth potential (22 females, 3 males; average age at primary surgery for scoliosis treatment is 11.4±1.2 years old) who had sliding growth guidance instrumentation LSZ-4D (CONMET) implanted on 13 (range: 10-16) spine levels for 6±2 years. The LSZ-4D device was made from titanium alloy Ti6Al4V and consisted of two rectangular section rods and fixture elements. Locked fixtures were used on one spinal level, whereas the others were unlocked (sliding). The control group consisted of 13 patients (12 females and 1 male; 11±1.2 years old) without any implanted devices.
Outcome Measures - The content of Ti, Al, and V metal ions in the whole blood and tissues around the implanted device was measured. The incidences of metallosis-associated complications in the study group were recorded.
Methods - Metal ion content was measured by the inductively coupled mass spectrometry method on quadrupolar NexION 300D (PerkinElmer Inc, Shelton, CT, USA).
Results - Five of 25 patients in the study group developed metallosis-associated complications (two sinuses and three seroma in the lumbar part of the spine). Revisions were carried out in two of these patients. Ninety percent of the patients in the study group had increased content of Ti and V ions in the blood (2.8 and 4 times, respectively). Median content of Ti ions in soft tissues adjacentto implanted sliding device was more than 1,500-fold higher than that of the control group. These levels are much higher than previously reported for spinal instrumentation.
Conclusions - Increased content of Ti and V ions in the blood and especially in tissues around the titanium growth guidance sliding device LSZ-4D accompanied by clinical manifestations (seroma and sinuses) indicates the importance of improving wear resistance of such instrumentation with the coatings and the necessity to exchange sliding instrumentation once the child is fully grown.
- Case-Control Studies
- Mass Spectrometry
- Postoperative Complications
- Prostheses and Implants
- Retrospective Studies