Achilles Allograft With or Without InternalBrace for ACL Revision Surgery

NCT07564336 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2026-05-08

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07564336 on ClinicalTrials.gov