Short-term clinical outcomes of Kyocera Modular Limb Salvage System designed cementless stems for the endoprosthetic reconstruction of lower extremities: a Japanese Musculoskeletal Oncology Group multi-institutional study
Authors: Tsukushi Satoshi , Nishida Yoshihiro , Hirose Takeshi , Nakata Eiji , Nakagawa Rumi , Nakamura Tomoki , Imanishi Jungo , Nagano Akihito , Tamiya Hironari , Ueda Takafumi ,   and Japanese Musculoskeletal Oncology Group (JMOG), Tsukushi Satoshi , Nishida Yoshihiro , Ikuta Kunihiro , Kawai Akira , Hirose Takeshi , Kunisada Toshiyuki , Nakata Eiji , Nakayama Robert , Nakagawa Rumi , Nakamura Tomoki , Torigoe Tomoaki , Imanishi Jungo , Nagano Akihito , Takenaka Satoshi , Tamiya Hironari , Ueda Takafumi , Kakunaga Shigeki , Kawano Hirotaka , Shirai Toshiharu , Terauchi Ryu , Outani Hidetatsu , Nishimura Shunji , Honoki Kanya 
Published: July 2022

Abstract
Background
The high rate of aseptic loosening of cemented stems has led to their frequent use in endoprosthetic reconstruction. However, problems, such as stem breakage and stress shielding at the insertion site, remain. The Japanese Musculoskeletal Oncology Group (JMOG) has developed Kyocera Modular Limb Salvage System (KMLS) cementless stems with a unique tapered press-fit and short fixation design. This study aimed to clarify the short-term postoperative outcomes of this prosthesis and validate the stem design.

Methods
One hundred cases of KMLS cementless stems (51 male patients; median age, 49 years; mean follow-up period, 35 months), with a minimum follow-up of 2 years, for the proximal femur (PF), distal femur (DF), and proximal tibia were prospectively registered for use. Prosthesis survival, complication rates, postoperative functional, and radiographical evaluation were analyzed. Complications or failures after insertion of the KMLS endoprostheses were classified into five types and functional results were analyzed according to the MSTS scoring system at postoperative 1 year. The diaphyseal interface and anchorage were graded by the ISOLS system at postoperative 2 years.

Results
The overall prosthesis survival rates at 2 and 4 years were 88.2 and 79.6%, respectively. The prosthesis-specific survival rate excluding infection and tumor recurrence was 90.2 and 87.9%, respectively. Younger age (p = 0.045) and primary tumor (p = 0.057) were associated with poor prognosis of prosthesis-specific survival excluding infection and tumor recurrence. Complications were observed in 31 patients, 13 patients underwent revision surgery. The mean MSTS functional score at 1 year postoperatively was 68%. Early implant loosening was significantly more common in the DF (p = 0.006) and PF/DF straight stem (p = 0.038). The ISOLS radiographic evaluation at 2 years after surgery revealed good bone remodeling and anchorage in most cases (bone remodeling: 90% / excellent and good, anchorage: 97% / excellent and good).

Conclusions
Tumor endoprosthesis long-term fixation to the diaphysis of the lower extremity remains challenging. The KMLS cementless stem with a unique tapered press fit design showed good short-term results in maintaining bone stock. To prevent early loosening, a curved stem should be used in PF and DF, but long-term follow-up is necessary.