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A prospective randomized controlled study to assess the effectiveness of super FIXSORB WAVE® for sternal stabilization after sternotomy

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Abstract

Background

We developed a new sternal fixation device, Super FIXSORB WAVE®, a corrugated plate made of u-HA/PLLA, to improve sternal stability after sternotomy. This present study aimed to evaluate the new device clinically.

Methods

This prospective, single-blinded, multicenter trial randomized 69 patients to either wire cerclage only (group C, n = 30) or wire cerclage plus Super FIXSORB WAVE® (group W, n = 39). The primary endpoint was a degree of sternal displacement at six months. Displacement of the sternal halves in the anteroposterior and lateral directions was measured using computed tomography horizontal section images at the third costal and fourth intercostal levels. The secondary endpoints were sternal pain and quality-of-life over 6 months.

Results

Group W showed significantly reduced sternal anteroposterior displacement at both the third costal (0 [0–1.9] mm vs. 1.1 [0–2.1] mm; P = 0.014) and fourth intercostal (0 [0–1.0] mm) vs. 1.0 [0–1.8] mm; P = 0.015) levels than group C. In group W, lateral displacement was suppressed without a significant increase from 2 weeks to 6 months, while it increased in group C. There was no significant difference in postoperative sternal pain and quality-of-life between the two groups. No adverse events, such as infection, inflammation, or foreign body reaction, were observed with this device.

Conclusions

Using Super FIXSORB WAVE®, sternal displacement was significantly suppressed in both the anteroposterior and lateral directions. The use of this device results in safe and easy sternal reinforcement without any adverse events, and sternal healing can be accelerated.

Clinical trial registry number

This study was registered in the Japan Registry of Clinical Trials (February 21, 2019; jRCTs032180146).

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Data availability

The data underlying this article will be shared on reasonable request to the corresponding author.

Abbreviations

BP:

Bodily pain

CPB:

Cardiopulmonary bypass

CBDA:

Cortical bone density area

DICOM:

Digital Imaging and Communications in Medicine

RE:

Emotional role functioning

FEV 1%:

Forced expiratory volume in 1 s

GH:

General health perceptions

HR-QoL:

Health-related quality-of-life

HbA1c:

Hemoglobin A1c

MH:

Mental health

NRS:

Numeric rating scale

PH:

Physical health

RF:

Physical role functioning

SF:

Social role functioning

u-HA/PLLA:

Unsintered hydroxyapatite poly-l-lactide acid

VT:

Vitality

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Acknowledgements

The authors would like to thank Drs. Ryuji Koike and Pariko Yorozu for their invaluable support in planning and conducting this research. We also thank Dr. Masafumi Yashima and Yasunori Sakamaki for surveillance of the research data.

Funding

This study is sponsored by Teijin Medical Technologies Co., Ltd., Osaka, Japan. The authors had full freedom in conducting the study and collecting and analyzing data. Furthermore, the authors had full freedom to explore the data and analyze the results independently from the sponsor.

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Authors and Affiliations

  1. Department of Cardiovascular Surgery, Graduate School of Medical and Dental Science, Tokyo Medical and Dental University, 1-5-45, Yushima, Bunkyo-Ku, Tokyo, 113-8519, Japan

    Kiyotoshi Oishi, Hirokuni Arai, Keiji Oi, Eiki Nagaoka, Tatsuki Fujiwara, Masashi Takeshita & Tomohiro Mizuno

  2. Department of Thoracic Surgery, Ome Municipal General Hospital, Tokyo, Japan

    Hidehito Kuroki & Takeshi Someya

  3. Department of Diagnostic Radiology, Tokyo Medical and Dental University, Tokyo, Japan

    Tomoyuki Fujioka

  4. School of Data Science, Yokohama City University, Kanagawa, Japan

    Makoto Tomita

  5. Department of Cardiovascular Surgery, Musashino Red Cross Hospital, Tokyo, Japan

    Dai Tasaki & Tomoya Yoshizaki

Authors
  1. Kiyotoshi Oishi
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  2. Hirokuni Arai
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  3. Hidehito Kuroki
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  13. Tomohiro Mizuno
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Corresponding author

Correspondence to Hirokuni Arai.

Ethics declarations

Conflict of interest

Drs. Kuroki and Arai hold a patent on the sternal fixation device (P6502161, 2019). All other authors have reported that they have no relationships relevant to the contents of this paper to disclosure.

Informed consent

Written informed consent was obtained from all the patients.

Institutional review board approval

December 15, 2016; R2016-027.

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Supplementary Information

Below is the link to the electronic supplementary material.

11748_2023_1928_MOESM1_ESM.tif

Supplementary Supplementary Fig1 The unsintered hydroxyapatite　poly-L-lactide acid corrugated plate (Super FIXSORB WAVE®, Teijin Medical Technologies Co., Ltd., Osaka, Japan) and devices for implantation. (a) A bone hardness meter. Pressing against a cross-section of the sternal trabecular bone helps measure the hardness. (b) Intraoperative images of corrugated plate insertion. Two corrugated plates cut to length with five inflection points per plate are inserted into the trabecular bone in the sternal body. (c) Special gripping forceps which designed for the insertion of the device. (d) The applicator of the same shape as the device. Insert this applicator into the sternal body and select the appropriate device size file1 (TIF 578 KB)

11748_2023_1928_MOESM2_ESM.tiff

Supplementary Supplementary Fig2 Comparison of postoperative sternal pain measured using a 0–10-numeric rating scale (NRS; 0 = none, 10 = worst) at 1, 2, 3, and 6 weeks and 3 and 6 months. Patients rated the sternal pain intensity at rest, during walking, and during coughing, respectively file2 (TIFF 440 KB)

11748_2023_1928_MOESM3_ESM.tiff

Supplementary Supplementary Fig3 Comparison of SF-36 scores. Norm-based scoring was used to standardize the scores from the survey with reference to the Japanese population mean (50) and standard deviation (10). Calculated SF-36 scores are presented as means ± standard deviations. See Methods for score abbreviations file3 (TIFF 588 KB)

Supplementary Sternal closure technique using bioabsorbable corrugated plate file4 (MPEG 135162 KB)

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Oishi, K., Arai, H., Kuroki, H. et al. A prospective randomized controlled study to assess the effectiveness of super FIXSORB WAVE® for sternal stabilization after sternotomy. Gen Thorac Cardiovasc Surg 71, 665–673 (2023). https://doi.org/10.1007/s11748-023-01928-5

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