1.Mechanical Effects of Offset and Length of the Cementless Stem for Initial Fixation to the Femur
Yutaro SHIBUTA ; Nobuhiro KAKU ; Kensei TANAKA ; Tsuguaki HOSOYAMA
Clinics in Orthopedic Surgery 2025;17(1):46-52
Background:
Implants with different neck offsets for hip replacement surgery are now available from various implant manufacturers and have become a widely used option for achieving postoperative hip stability. This study aimed to compare the impact of neck offset on initial stem fixation and the mechanical effects of different stem lengths when using cementless stems.
Methods:
We performed a finite element analysis using Mechanical Finder ver. 12.0. CAD models of the Profemur Preserve and Profemur TL cementless stems. Each stem was appropriately sized, and the von Mises stress was calculated. We defined micromotion as the relative displacement between the stem node and the surface of bone contact. The maximum micromotion values of these finite element models were compared under standing conditions.
Results:
The stress per zone for both stems (Preserve and TL) was the highest in zone 5, followed by zones 3 and 4, which were almost in line with each other. The high offset (HIGH) stress was higher than the standard offset (STD) stress in each stem and zone.The micromotion of each stem was higher at each load in the following order: Preserve HIGH, Preserve STD, TL HIGH, and TL STD, with HIGH being higher than STD at each stem.
Conclusions
The choice of higher offset or shorter length stems induced higher micromotion at the interface to the bone in the early postoperative period. Therefore, surgeons should be more careful to get appropriate initial fixation using shorter stems with higher offset necks due to the relatively high incidence of loosening or fractures.
2.Mechanical Effects of Offset and Length of the Cementless Stem for Initial Fixation to the Femur
Yutaro SHIBUTA ; Nobuhiro KAKU ; Kensei TANAKA ; Tsuguaki HOSOYAMA
Clinics in Orthopedic Surgery 2025;17(1):46-52
Background:
Implants with different neck offsets for hip replacement surgery are now available from various implant manufacturers and have become a widely used option for achieving postoperative hip stability. This study aimed to compare the impact of neck offset on initial stem fixation and the mechanical effects of different stem lengths when using cementless stems.
Methods:
We performed a finite element analysis using Mechanical Finder ver. 12.0. CAD models of the Profemur Preserve and Profemur TL cementless stems. Each stem was appropriately sized, and the von Mises stress was calculated. We defined micromotion as the relative displacement between the stem node and the surface of bone contact. The maximum micromotion values of these finite element models were compared under standing conditions.
Results:
The stress per zone for both stems (Preserve and TL) was the highest in zone 5, followed by zones 3 and 4, which were almost in line with each other. The high offset (HIGH) stress was higher than the standard offset (STD) stress in each stem and zone.The micromotion of each stem was higher at each load in the following order: Preserve HIGH, Preserve STD, TL HIGH, and TL STD, with HIGH being higher than STD at each stem.
Conclusions
The choice of higher offset or shorter length stems induced higher micromotion at the interface to the bone in the early postoperative period. Therefore, surgeons should be more careful to get appropriate initial fixation using shorter stems with higher offset necks due to the relatively high incidence of loosening or fractures.
3.Mechanical Effects of Offset and Length of the Cementless Stem for Initial Fixation to the Femur
Yutaro SHIBUTA ; Nobuhiro KAKU ; Kensei TANAKA ; Tsuguaki HOSOYAMA
Clinics in Orthopedic Surgery 2025;17(1):46-52
Background:
Implants with different neck offsets for hip replacement surgery are now available from various implant manufacturers and have become a widely used option for achieving postoperative hip stability. This study aimed to compare the impact of neck offset on initial stem fixation and the mechanical effects of different stem lengths when using cementless stems.
Methods:
We performed a finite element analysis using Mechanical Finder ver. 12.0. CAD models of the Profemur Preserve and Profemur TL cementless stems. Each stem was appropriately sized, and the von Mises stress was calculated. We defined micromotion as the relative displacement between the stem node and the surface of bone contact. The maximum micromotion values of these finite element models were compared under standing conditions.
Results:
The stress per zone for both stems (Preserve and TL) was the highest in zone 5, followed by zones 3 and 4, which were almost in line with each other. The high offset (HIGH) stress was higher than the standard offset (STD) stress in each stem and zone.The micromotion of each stem was higher at each load in the following order: Preserve HIGH, Preserve STD, TL HIGH, and TL STD, with HIGH being higher than STD at each stem.
Conclusions
The choice of higher offset or shorter length stems induced higher micromotion at the interface to the bone in the early postoperative period. Therefore, surgeons should be more careful to get appropriate initial fixation using shorter stems with higher offset necks due to the relatively high incidence of loosening or fractures.
4.Mechanical Effects of Offset and Length of the Cementless Stem for Initial Fixation to the Femur
Yutaro SHIBUTA ; Nobuhiro KAKU ; Kensei TANAKA ; Tsuguaki HOSOYAMA
Clinics in Orthopedic Surgery 2025;17(1):46-52
Background:
Implants with different neck offsets for hip replacement surgery are now available from various implant manufacturers and have become a widely used option for achieving postoperative hip stability. This study aimed to compare the impact of neck offset on initial stem fixation and the mechanical effects of different stem lengths when using cementless stems.
Methods:
We performed a finite element analysis using Mechanical Finder ver. 12.0. CAD models of the Profemur Preserve and Profemur TL cementless stems. Each stem was appropriately sized, and the von Mises stress was calculated. We defined micromotion as the relative displacement between the stem node and the surface of bone contact. The maximum micromotion values of these finite element models were compared under standing conditions.
Results:
The stress per zone for both stems (Preserve and TL) was the highest in zone 5, followed by zones 3 and 4, which were almost in line with each other. The high offset (HIGH) stress was higher than the standard offset (STD) stress in each stem and zone.The micromotion of each stem was higher at each load in the following order: Preserve HIGH, Preserve STD, TL HIGH, and TL STD, with HIGH being higher than STD at each stem.
Conclusions
The choice of higher offset or shorter length stems induced higher micromotion at the interface to the bone in the early postoperative period. Therefore, surgeons should be more careful to get appropriate initial fixation using shorter stems with higher offset necks due to the relatively high incidence of loosening or fractures.
5.Niraparib in Japanese patients with platinum-sensitive recurrent ovarian cancer: final results of a multicenter phase 2 study
Hiroaki ITAMOCHI ; Nobuhiro TAKESHIMA ; Junzo HAMANISHI ; Kosei HASEGAWA ; Motoki MATSUURA ; Kiyonori MIURA ; Shoji NAGAO ; Hidekatsu NAKAI ; Naotake TANAKA ; Hideki TOKUNAGA ; Shin NISHIO ; Hidemichi WATARI ; Yoshihito YOKOYAMA ; Yoichi KASE ; Shuuji SUMINO ; Ai KATO ; Ajit SURI ; Toshiaki YASUOKA ; Kazuhiro TAKEHARA
Journal of Gynecologic Oncology 2024;35(5):e115-
Objective:
This study evaluated the long-term safety and efficacy of niraparib in Japanese patients with platinum-sensitive recurrent ovarian cancer.
Methods:
This was a follow-up analysis of a phase 2, multicenter, open-label, single-arm study in Japanese women with platinum-sensitive, relapsed ovarian cancer. Participants received niraparib (starting dose 300 mg) once daily in continuous 28-day cycles. The primary endpoint was the incidence of Grade 3 or 4 thrombocytopenia-related events (defined as the overall incidence of the MedDRA Preferred Terms “thrombocytopenia” and “platelet count decreased”) occurring in the 30 days after initial administration of niraparib, and secondary endpoints included evaluation of treatment-emergent adverse events and progression-free survival.
Results:
Nineteen patients (median age, 62 years; median body weight, 53.9 kg) were enrolled. As previously reported, the incidence of Grade 3 or 4 thrombocytopenia-related events during the first 30 days of treatment was 31.6%. At data cutoff, median (range) treatment exposure was 504.0 (56–1,054) days and mean ± standard deviation dose intensity was 154.4±77.5 mg/day. The most common treatment-emergent adverse events were nausea (n=14, 73.7%), decreased platelet count (n=12, 63.2%), decreased neutrophil count (n=11, 57.9%), anemia, vomiting, and decreased appetite (all n=9, 47.4%). One patient was diagnosed with treatment-related leukemia, which resulted in death. Median (95% confidence interval) progression-free survival was 18.0 (5.6–26.7) months.
Conclusion
Overall, the safety profile of niraparib was considered manageable in this study population of Japanese patients with platinum-sensitive, relapsed ovarian cancer and was consistent with that observed in studies of non-Japanese patients.
6.Niraparib in Japanese patients with platinum-sensitive recurrent ovarian cancer: final results of a multicenter phase 2 study
Hiroaki ITAMOCHI ; Nobuhiro TAKESHIMA ; Junzo HAMANISHI ; Kosei HASEGAWA ; Motoki MATSUURA ; Kiyonori MIURA ; Shoji NAGAO ; Hidekatsu NAKAI ; Naotake TANAKA ; Hideki TOKUNAGA ; Shin NISHIO ; Hidemichi WATARI ; Yoshihito YOKOYAMA ; Yoichi KASE ; Shuuji SUMINO ; Ai KATO ; Ajit SURI ; Toshiaki YASUOKA ; Kazuhiro TAKEHARA
Journal of Gynecologic Oncology 2024;35(5):e115-
Objective:
This study evaluated the long-term safety and efficacy of niraparib in Japanese patients with platinum-sensitive recurrent ovarian cancer.
Methods:
This was a follow-up analysis of a phase 2, multicenter, open-label, single-arm study in Japanese women with platinum-sensitive, relapsed ovarian cancer. Participants received niraparib (starting dose 300 mg) once daily in continuous 28-day cycles. The primary endpoint was the incidence of Grade 3 or 4 thrombocytopenia-related events (defined as the overall incidence of the MedDRA Preferred Terms “thrombocytopenia” and “platelet count decreased”) occurring in the 30 days after initial administration of niraparib, and secondary endpoints included evaluation of treatment-emergent adverse events and progression-free survival.
Results:
Nineteen patients (median age, 62 years; median body weight, 53.9 kg) were enrolled. As previously reported, the incidence of Grade 3 or 4 thrombocytopenia-related events during the first 30 days of treatment was 31.6%. At data cutoff, median (range) treatment exposure was 504.0 (56–1,054) days and mean ± standard deviation dose intensity was 154.4±77.5 mg/day. The most common treatment-emergent adverse events were nausea (n=14, 73.7%), decreased platelet count (n=12, 63.2%), decreased neutrophil count (n=11, 57.9%), anemia, vomiting, and decreased appetite (all n=9, 47.4%). One patient was diagnosed with treatment-related leukemia, which resulted in death. Median (95% confidence interval) progression-free survival was 18.0 (5.6–26.7) months.
Conclusion
Overall, the safety profile of niraparib was considered manageable in this study population of Japanese patients with platinum-sensitive, relapsed ovarian cancer and was consistent with that observed in studies of non-Japanese patients.
7.Niraparib in Japanese patients with platinum-sensitive recurrent ovarian cancer: final results of a multicenter phase 2 study
Hiroaki ITAMOCHI ; Nobuhiro TAKESHIMA ; Junzo HAMANISHI ; Kosei HASEGAWA ; Motoki MATSUURA ; Kiyonori MIURA ; Shoji NAGAO ; Hidekatsu NAKAI ; Naotake TANAKA ; Hideki TOKUNAGA ; Shin NISHIO ; Hidemichi WATARI ; Yoshihito YOKOYAMA ; Yoichi KASE ; Shuuji SUMINO ; Ai KATO ; Ajit SURI ; Toshiaki YASUOKA ; Kazuhiro TAKEHARA
Journal of Gynecologic Oncology 2024;35(5):e115-
Objective:
This study evaluated the long-term safety and efficacy of niraparib in Japanese patients with platinum-sensitive recurrent ovarian cancer.
Methods:
This was a follow-up analysis of a phase 2, multicenter, open-label, single-arm study in Japanese women with platinum-sensitive, relapsed ovarian cancer. Participants received niraparib (starting dose 300 mg) once daily in continuous 28-day cycles. The primary endpoint was the incidence of Grade 3 or 4 thrombocytopenia-related events (defined as the overall incidence of the MedDRA Preferred Terms “thrombocytopenia” and “platelet count decreased”) occurring in the 30 days after initial administration of niraparib, and secondary endpoints included evaluation of treatment-emergent adverse events and progression-free survival.
Results:
Nineteen patients (median age, 62 years; median body weight, 53.9 kg) were enrolled. As previously reported, the incidence of Grade 3 or 4 thrombocytopenia-related events during the first 30 days of treatment was 31.6%. At data cutoff, median (range) treatment exposure was 504.0 (56–1,054) days and mean ± standard deviation dose intensity was 154.4±77.5 mg/day. The most common treatment-emergent adverse events were nausea (n=14, 73.7%), decreased platelet count (n=12, 63.2%), decreased neutrophil count (n=11, 57.9%), anemia, vomiting, and decreased appetite (all n=9, 47.4%). One patient was diagnosed with treatment-related leukemia, which resulted in death. Median (95% confidence interval) progression-free survival was 18.0 (5.6–26.7) months.
Conclusion
Overall, the safety profile of niraparib was considered manageable in this study population of Japanese patients with platinum-sensitive, relapsed ovarian cancer and was consistent with that observed in studies of non-Japanese patients.
9.Foramen Magnum Decompression with Outer Dura Matter Layer Resection for Chiari Type I Malformation: Factors Correlated with Syrinx Reduction
Toshiaki MARUYAMA ; Toshio NAKAMAE ; Naosuke KAMEI ; Nobuhiro TANAKA ; Yasushi FUJIWARA ; Takahiro HARADA ; Nobuo ADACHI
Asian Spine Journal 2023;17(2):365-372
Methods:
We enrolled patients who underwent microscopic FMD with outer dural layer resection for CMI. The distance from the tip of the cerebellar tonsil to the C2 vertebral endplate on sagittal magnetic resonance imaging (MRI) was defined as the tonsillar distance (TD). Patients who showed a >20% syrinx diameter reduction on the 1-year follow-up MRI were defined as the syrinx reduction group while the others were categorized in the syrinx nonreduction group. Patients with syringomyelia were categorized into the clinically improved and unimproved groups using the Chicago Chiari Outcome Scale. The imaging and clinical parameters were evaluated pre- and postoperatively.
Results:
This study included 25 patients of whom 19 (76.0%) had syringomyelia. At the 1-year follow-up, the syrinx diameter had decreased in 11 patients (57.8%). The increased TD significantly differed between the syrinx reduction and nonreduction groups. At the 1-year follow-up, 12 and seven patients with syringomyelia were categorized into the clinically improved and unimproved groups, respectively. The clinically improved and unimproved groups showed significant differences in the mean age and increased TD.
Conclusions
Postoperative syrinx reduction was significantly correlated with the upward shifting of the cerebellar tonsil in patients with CMI. Our quantitative evaluation of the alterations in hindbrain position after FMD was easily performed and reflects the clinical outcomes.
10.Physical Signs and Clinical Features of Cervical Myelopathy in Elderly Patients, Especially 80 Years or Older: Comparison of 100 Consecutive Operative Cases across Three Age Groups
Takahiko HAMASAKI ; Toshio NAKAMAE ; Naosuke KAMEI ; Yasushi FUJIWARA ; John M. RHEE ; Nobuhiro TANAKA ; Yoshinori FUJIMOTO ; Nobuo ADACHI ; Shoji SHIMOSE
Asian Spine Journal 2023;17(5):916-921
Methods:
We evaluated 100 consecutive surgical patients with CM and divided them into the following groups: 80s (34 patients; mean age, 83.9 years), 70s (33 patients; mean age, 73.9 years), and 69 or younger (33 patients; mean age, 60.9 years). The clinical symptoms and physical signs were evaluated and recorded.
Results:
Although the recovery rate decreased with increasing age, all groups demonstrated a significant improvement in clinical symptoms relative to preoperative values. The Hoffman sign and hyperreflexia of the triceps tendon were, respectively, present in 82% and 88% of patients in the 80s group, 74% and 64% of those in the 70s group, and 69% and 82% of those in the 69 or younger group, with no significant difference among the groups. In contrast, the rates of hyperreflexia of the patellar and Achilles tendons were, respectively, 59% and 32% in the 80s group, 85% and 48% in the 70s group, and 91% and 70% in the 69 or younger group, with significant differences.
Conclusions
The positivity rate of the lower extremity hyperreflexia decreased significantly with increasing age in patients with CM. The absence of hyperreflexia, particularly lower extremity, is not uncommon in elderly patients with suspected CM.

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