Achilles Allograft With or Without InternalBrace for ACL Revision Surgery
NCT07564336 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32
Last updated 2026-05-08
Summary
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.
Conditions
- Anterior Cruciate Ligament Injury
- Anterior Cruciate Ligament Rupture
- Anterior Cruciate Ligament Graft Failure
- Knee Instability
Interventions
- PROCEDURE
-
Revision ACL Reconstruction With Achilles Tendon Allograft and InternalBrace Augmentation
Revision anterior cruciate ligament reconstruction was performed using an Achilles tendon allograft with calcaneal bone block. In this group, a non-resorbable polyethylene FiberTape InternalBrace was additionally fixed separately and independently from the ACL allograft to support the graft during healing.
- PROCEDURE
-
Revision ACL Reconstruction With Achilles Tendon Allograft Without InternalBrace Augmentation
Revision anterior cruciate ligament reconstruction was performed using an Achilles tendon allograft with calcaneal bone block. No additional InternalBrace or suture tape augmentation was used. Apart from the absence of InternalBrace augmentation, the surgical technique and postoperative rehabilitation protocol were the same as in the InternalBrace augmentation group.
Sponsors & Collaborators
-
Medical University of Graz
lead OTHER
Principal Investigators
-
Paul Ruckenstuhl, MD · Department of Orthopaedics and Trauma, Medical University of Graz
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-02-01
- Primary Completion
- 2021-09-30
- Completion
- 2021-09-30
Countries
- Austria
Study Locations
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