Study on the strength of SuperFIXSORB sheet of 0.3mm thickness after implantation in vivo.

Study on the strength of SuperFIXSORB sheet of 0.3mm thickness after implantation in vivo. - Study on the strength of SuperFIXSORB sheet of 0.3mm thickness after implantation in vivo.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000049087

Enrollment

Registered

2022-10-03

Start date

2022-10-03

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Orbital fracture

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients who have had a SuperFIXSORB 0.3mm thick sheet implanted in the orbit and then had the sheet removed due to clinical necessity.

Exclusion criteria

Exclusion criteria: Cases that might differ from the normal degradation process, such as infection or foreign body reaction, will be excluded.

Design outcomes

Primary

Measure	Time frame
Verify that the viscosity-averaged molecular weight of the removed specimen is not less than that of the same material in the in vitro degradation test. Although the timing of postoperative specimen removal varies from case to case, if the bending strength of the removed specimens at each time point is not less than the results of in vitro degradation tests, it can be assumed that implants placed in the human orbit also have sufficient bending strength at 12 months postoperatively.	—

Measure

Time frame

Verify that the viscosity-averaged molecular weight of the removed specimen is not less than that of the same material in the in vitro degradation test. Although the timing of postoperative specimen removal varies from case to case, if the bending strength of the removed specimens at each time point is not less than the results of in vitro degradation tests, it can be assumed that implants placed in the human orbit also have sufficient bending strength at 12 months postoperatively.

—

Secondary

Measure	Time frame
Compare the crystallinity of the extracted specimens with that measured in in vitro degradation test.	—

Countries

Japan

Contacts

Public ContactTomoya Kawabata

Kobe City Medical Center General Hospital Department of Plastic and Reconstructive Surgery

tk9216@kuhp.kyoto-u.ac.jp078-302-4321

Outcome results