Achilles Allograft With or Without InternalBrace for ACL Revision Surgery

This study evaluated outcomes after revision anterior cruciate ligament reconstruction using Achilles tendon allografts with a calcaneal bone block, with or without additional InternalBrace augmentation. Revision ACL reconstruction is often more complex than primary ACL reconstruction because previous surgery may leave widened bone tunnels or bone defects. Achilles tendon allografts with attached bone blocks may help address these defects and allow reconstruction in a single surgical procedure. Participants with MRI-confirmed ACL graft re-tear and clinical knee instability were randomized to undergo revision ACL reconstruction either with InternalBrace augmentation or without InternalBrace augmentation. Clinical outcomes, patient-reported knee function, health-related quality of life, and MRI findings were assessed during 13 months of follow-up. The study was designed as a prospective randomized controlled pilot trial to compare whether additional InternalBrace augmentation improved functional, radiographic, or quality-of-life outcomes after revision ACL surgery.

NCT Number	NCT07564336
Lead Sponsor	Medical University of Graz
Conditions	Anterior Cruciate Ligament Injury, Anterior Cruciate Ligament Rupture, Anterior Cruciate Ligament Graft Failure, Knee Instability
Enrollment	32 participants
Start Date	2017-02-01
Primary Completion	2021-09-30 (estimated)
Study Completion	2021-09-30 (estimated)
Updated on ClinicalTrials.gov	2026-05-08