PRECICE^®magnetically-driven, telescopic, intramedullary lengthening nail: pre-clinical testing and first 30 patients

Abstract

Introduction: Femoral/tibial lengthening with a telescopic, magnetically-powered, intramedullary nail is an alternative to lengthening with external fixation. Methods: Pre-clinical testing was conducted of the PRECICE in a human cadaver. A retrospective review of the first 30 consecutive patients who underwent unilateral lengthening was also conducted. Nail accuracy was obtained by comparing the amount of nail distraction to the final bone length achieved at the end of the distraction process. Relative standard deviation of accuracy was used to calculate nail precision. Results: Devices performed successfully in a human cadaver. Thirty consecutive patients (10 females, 20 males; mean age, 23 years) with limb length discrepancy (LLD) were followed an average of 19 months (range, 12–24 months). Etiology included congenital shortening (14), posttraumatic deformities (7), Ollier disease (3), osteosarcoma resection (1), prior clubfoot (2), hip dysplasia (1), post-septic growth arrest of knee (1), and LLD after hip arthroplasty (1). Twenty-four femoral and eight tibial nails were implanted. Mean preoperative lengthening goal was 4.4 cm (range, 2–6.5 cm); mean postoperative length achieved was 4.3 cm (range, 1.5–6.5 cm). Average consolidation index was 36.4 days/cm (range, 12.8–113 days/cm). Mean nail accuracy was 97.3% with a precision of 92.4%. Average preoperative and 12-month postoperative Enneking scores were 21.5 and 25.3 (p < 0.001), respectively. The preoperative and 12-month postoperative SF-12 physical and mental component scores were not statistically different. Nine complications (nine limb segments) resolved: two partial femoral unions, two suspected deep vein thrombosis (DVT), one delayed tibial union, one fibular nonunion, one peroneal nerve irritation, one knee joint subluxation, and one confirmed DVT. Twenty-nine (91%) of 32 limb segments achieved successful bone healing without revision surgery. Discussion: Limb lengthening with PRECICE is reliable, but larger trials with longer follow-up will reveal limitations. Implantable nails prevent problems associated with external fixation, such as muscle tethering and pin-site infections.

Tibial lengthening using a retrograde magnetically driven intramedullary lengthening device in 10 patients with preexisting ankle and hindfoot fusion

“…The DIX was reported as 0.48-0.84 mm/day (Tiefenboeck et al 2016, Wiebking et al 2016, Wagner et al 2017, Nasto et al 2020 and the CIX amounted to 0.5-3.3 months/cm (Shabtai et al 2014, Tiefenboeck et al 2016, Horn et al 2019, Cosic and Edwards 2020, Nasto et al 2020. Non-union was encountered in 11-75% (Kirane et al 2014, Shabtai et al 2014, Tiefenboeck et al 2016, Wiebking et al 2016, Wagner et al 2017, Cosic and Edwards 2020, Nasto et al 2020. These findings are comparable to our results for distal tibial distraction osteogenesis using a retrograde ILN with non-union in one-fifth of patients and a CIX of 1.5 months/cm, indicating at least equivalent bone healing potential.…”

“…Fully implantable intramedullary lengthening nails (ILNs) with mechanical (Guichet and Casar 1997 , Cole et al 2001 ) and motorized (Baumgart et al 1997 , Schiedel et al 2014 ) drive systems have been developed as an alternative to external fixators for bone lengthening (Mahboubian et al 2012 , Black et al 2015 , Laubscher et al 2016 ). Recently, magnetically driven ILNs in particular have become increasingly popular (Kirane et al 2014 , Wagner et al 2017 ) and in contrast to external fixation provide an equally safe and more comfortable option for limb lengthening and deformity correction (Szymczuk et al 2019 , Horn et al 2019 ). Antegrade or retrograde femoral and antegrade tibial lengthening with the PRECICE limb lengthening system (NuVasive, San Diego, CA, USA) has been assessed by several studies (Kirane et al 2014 , Schiedel et al 2014 , Shabtai et al 2014 , Tiefenboeck et al 2016 , Wiebking et al 2016 , Fragomen and Rozbruch 2017 , Wagner et al 2017 , Iobst et al 2018 , Cosic and Edwards 2020 , Nasto et al 2020 ).…”

“…Recently, magnetically driven ILNs in particular have become increasingly popular (Kirane et al 2014 , Wagner et al 2017 ) and in contrast to external fixation provide an equally safe and more comfortable option for limb lengthening and deformity correction (Szymczuk et al 2019 , Horn et al 2019 ). Antegrade or retrograde femoral and antegrade tibial lengthening with the PRECICE limb lengthening system (NuVasive, San Diego, CA, USA) has been assessed by several studies (Kirane et al 2014 , Schiedel et al 2014 , Shabtai et al 2014 , Tiefenboeck et al 2016 , Wiebking et al 2016 , Fragomen and Rozbruch 2017 , Wagner et al 2017 , Iobst et al 2018 , Cosic and Edwards 2020 , Nasto et al 2020 ).…”

Alargamiento Oseo Con Clavo Intramedular Magnetico Experiencia Preliminar y Lecciones Aprendidas

“…Los tiempos de consolidación, medidos con el HI fueron de 46,5 días/cm. Aunque esa cifra es similar a la reportada en diversos estudios 7,12,23,24 la presente serie incluye tanto alargamiento de Fémur como Tibia, en pacientes de diferentes edades y con diagnósticos de base diferentes, lo que hace poco fiable la comparación.…”

“…A diferencia de los otros pacientes sometidos a la misma intervención, la evaluación psicológica no fue realizada por la psicóloga de nuestro equipo, quien cuenta con una gran experiencia en el examen de esos pacientes. Eso no hace más que confirmar la importancia de un equipo multidisciplinario, que incluye al cirujano, kinesiólogo, fisiatra y psicólogo 24,25 que puedan evaluar en conjunto y conversar directamente respecto a cada paciente en particular. La lesión del N. Peroneo común registrada en 1 paciente, sometido a osteotomía correctora y alargamiento de ambas Tibias, ocurrió durante la perforación para el tornillo de bloqueo más proximal.…”