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Randomized controlled trial evaluating the effect of new sternal fixation device for the patients who undergo open heart surgery (New sternal fixation device study)

New sternal fixation device study (NSX Study)

70

The inclusion criteria included patients aged over 20 years who underwent elective cardiovascular surgery via a median full sternotomy and whose sternal size, as measured on preoperative computed tomography images, met the following criteria. The trabecular bone thickness of the sternal body was in the range of 4-8.5 mm and width in the range of 19-31 mm from the lower margin of the second rib to the lower margin of the fifth rib. The preoperative exclusion criteria included patients with diabetes mellitus (Hemoglobin A1c (HbA1c) over 8.0%), chronic steroid or immunosuppressive agent use, chronic obstructive pulmonary disease (forced expiratory volume in 1 s (FEV 1%) under 70% and percent predicted FEV1% under 50%), active infection, dialysis-dependent renal failure, and dementia. Intraoperative exclusion criteria included significant off-midline sternotomies, a complete sternal fracture, or a too hard sternal trabecular bone. The hardness of the sternal trabecular bone was measured after sternotomy using a bone hardness meter (Teijin Medical Technologies Co., Ltd., Osaka, Japan)

The planned number of 70 patients participated in the study, and all patients completed the follow-up after 6 months postoperatively.

One patient underwent re-exploration due to postoperative bleeding and required removal of the device, but the cause of bleeding was not related to the device. There were no other clinical study-related illnesses in patients with or without the device.

Corrugated plate insertion significantly reduced the anteroposterior sternal displacement at 6 months compared to wire cerclage only. In the corrugated plate insertion group, lateral sternal separation was not significantly increased from 2 weeks to 6 months, whereas in the group treated with only wire cerclage, sternal separation was significantly increased. Although corrugated plate insertion was associated with a trend toward better scores in physical functioning and body pain in the early postoperative period, there was no significant difference in postoperative sternal pain and quality-of-life between the two groups.

Corrugated plate insertion resulted in significantly suppressed sternal displacement in both the anteroposterior and lateral directions. The use of corrugated plate insertion results in safe and easy sternal reinforcement without adverse events, and sternal healing can be accelerated.

Nov. 30, 2021

No

None planned

https://jrct.mhlw.go.jp/latest-detail/jRCTs032180146

Arai Hirokuni

Tokyo Medical and Dental University

1-5-45 Yushima, Bunkyo-ku, Tokyo 113-8519, JAPAN

hiro.cvsg@tmd.ac.jp

Oishi Kiyotoshi

Tokyo Medical and Dental University

1-5-45 Yushima, Bunkyo-ku, Tokyo 113-8519, JAPAN

+81-3-5803-5270

oishi.cvsg@tmd.ac.jp

Complete

Dec. 15, 2016

Interventional

randomized controlled trial

single blind

active control

parallel assignment

treatment purpose

Adult patients who undergo cardiovascular surgery with full sternotomy

Emergency, Diabetes (HbA1c is 8.0% and more), Hemodialysis, Steroid, Immunosuppressant, Severe COPD, Ventricular assist device, Infectious endocarditis, and Pacemaker lead infection

Both

Cardiovascular Diseases

Sternal closure with new sternal fixation device, which is inserted in bone marrow, followed by wire cerclage

Displacement of sternal halves (CT scan): 6 months after surgery

Displacement of sternal halves (CT scan): 2weeks and 3 months after surgery
Dihisecnce, Bone union, and CBDA; Cortical bone density area (CT scan): 2weeks, 3months, and 6months after surgery
Sternal infection and Pain score: 1week, 2weeks, 3weeks, 6weeks, 3months, and 6months after surgery
Quality of Life: 2weeks, 3weeks, 6weeks, 3months, and 6months after surgery

+81-3-5803-4575

Oct. 19, 2018

none