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StoppedWithdrawn before enrollingSponsor's reason: PI left institutionEnrollment target: estimated 200 to confirmed 0 · Study sites: 1 to 0 · Eligibility criteria expanded, about 9 words · 3 moreShow 6 more changesShow less
Enrollment target: estimated 200 to confirmed 0
Study sites: 1 to 0
Eligibility criteria expanded, about 9 words
Secondary endpoints: details revised at 24 of 48 entries
Study description revised
Publications: details revised at 10 of 10 entries
NotableStart date: Aug 2025 to Sep 2026Site contact updatedv6Show 1 more changeShow less
Site contact updated
NotableStart date: Dec 2023 to Aug 2025Site contact updatedv5Show 1 more changeShow less
Site contact updated
NotableStart date: Mar 10, 2023 to Dec 2023v4
NotableStart date: Sep 2022 to Mar 10, 2023v3
MinorStudy sites: 0 to 1v2
MinorStudy First Submitted
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
There is no consensus regarding the best surgical management of primary ACL tears. Recent evidence suggests that internal brace augmentation may increase load failure and therefore stabilize the graft in-situ at the time of ACL reconstruction. This prospective randomized controlled trial aims to compare the time to return to activity, and participant reported outcomes in participants with bone-tendon-bone ACL reconstruction with and without (control) internal brace augmentation.