Notice of Clinical Study Ver. 1.0 April 1, 2026
This clinic is conducting a retrospective observational study using information obtained during routine care. In accordance with Japan’s Ethical Guidelines for Medical and Health Research Involving Human Subjects, we use public disclosure and the right to refuse participation (opt-out) instead of obtaining written informed consent from each patient. Upon request, we can provide an overview of the study to the extent that no individuals are identified. If you do not wish your data to be used, please contact us as described below. Your care will not be affected in any way.
Study Title
ACLOAS MRI Outcomes of an Evo-Devo–Based Dynamic Nonoperative Protocol for ACL Rupture: Single-Arm Observational Study with External Comparison to the Cross-Bracing Protocol
Institution / Principal Investigator
Matsumoto Jun Sekkotsuin/ Jun Matsumoto (Principal Investigator)
Purpose
To evaluate MRI outcomes (ACLOAS grades) of a dynamic nonoperative protocol for ACL rupture and compare them with published data on the Cross-Bracing Protocol (CBP).
Participants (Target Period)
Patients who received nonoperative care for ACL rupture at our clinic between September 1, 2020, and March 31, 2025, and underwent both the first and second MRIs (DICOM). All treatments have already been completed; no additional visits or tests are required.
Information Used
Age, sex, days from injury to treatment, days from injury to MRI (including categorical classifications), brace use, presence of full extension, concomitant injuries (meniscal and MCL/LCL injuries), Ihara grade, and ACLOAS score. Direct identifiers (e.g., name, address) are not used.
Imaging Assessment (Outsourcing)
Three board-certified radiologists independently assess the images. The final rating follows a majority rule (≥2/3 agreement); if all three disagree, a consensus discussion determines the final rating. This process is outsourced to Wise Reading Co., Ltd. (Japan). To protect your privacy, direct identifiers (e.g., name, patient ID) are removed or replaced with a study-specific ID before the data is shared.
Research Period
From the date of institutional approval until December 31, 2026.
Opt-Out Period
From the date of institutional approval until March 31, 2027. (The first 4 weeks are designated as the guaranteed period for data exclusion. Requests to opt-out are accepted throughout the study period).
Planned Analysis Start Date
2026-July-1 (Scheduled to begin after the minimum 4-week public disclosure period).
Note: Please understand that it will be impossible to remove your specific data once the analysis has begun or the results have been submitted or published.
Data Retention
5 years after study completion. The link table connecting patient names to study IDs will be managed securely under restricted access within the clinic.
How to Decline (Opt-Out)
Please contact us by email, phone, or at the reception desk. To identify your record, please provide your patient number and/or visit date.
Email: ivanivankov@yahoo.co.jp
Phone: 090-5659-0341 (Weekdays 9:00–17:00)
Ethics Review
This study has been reviewed and approved by the Institutional Review Board of National Hospital Organization Osaka Medical Center.
Posting Date
[2026-May-01]