Achilles Allograft With or Without InternalBrace for ACL Revision Surgery

NCT07564336 | Completed DMC

• 1 other identifier: 29-201 ex 16/17
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

ACL Revision Surgery; Anterior Cruciate Ligament Revision; ACL Reconstruction; Achilles Tendon Allograft; Allograft Reconstruction; InternalBrace; Suture Tape Augmentation; Knee Surgery; Revision ACL Reconstruction; Bone Block Allograft

Outcome Measures

Primary Outcomes (1)

• International Knee Documentation Committee Score

  The International Knee Documentation Committee score was used to assess patient-reported knee symptoms, function, and sports activity after revision anterior cruciate ligament reconstruction. Scores range from 0 to 100, with higher scores indicating better knee function.

  Preoperative baseline to 13 months after surgery

Secondary Outcomes (7)

• Lysholm Knee Questionnaire Score

  Preoperative baseline to 13 months after surgery

• Tegner Activity Scale Score

  Preoperative baseline to 13 months after surgery

• Knee Injury and Osteoarthritis Outcome Score

  Preoperative baseline to 13 months after surgery

• Short Form-36 Physical Component Summary Score

  Preoperative baseline to 13 months after surgery

• Short Form-36 Mental Component Summary Score

  Preoperative baseline to 13 months after surgery

Study Arms (2)

InternalBrace Augmentation

EXPERIMENTAL

Participants underwent revision anterior cruciate ligament reconstruction using an Achilles tendon allograft with calcaneal bone block and additional InternalBrace augmentation. The InternalBrace consisted of non-resorbable polyethylene FiberTape fixed separately and independently from the ACL allograft.

Procedure: Revision ACL Reconstruction With Achilles Tendon Allograft and InternalBrace Augmentation

No InternalBrace Augmentation

ACTIVE COMPARATOR

Participants underwent revision anterior cruciate ligament reconstruction using an Achilles tendon allograft with calcaneal bone block without additional InternalBrace augmentation. Apart from the InternalBrace augmentation, the surgical technique and postoperative rehabilitation protocol were the same as in the InternalBrace group.

Procedure: Revision ACL Reconstruction With Achilles Tendon Allograft Without InternalBrace Augmentation

Interventions

Revision ACL Reconstruction With Achilles Tendon Allograft and InternalBrace Augmentation PROCEDURE

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.

Also known as: Revision ACL Reconstruction With InternalBrace, ACL Revision Surgery With InternalBrace Augmentation, Achilles Tendon Allograft ACL Revision With Suture Tape Augmentation

InternalBrace Augmentation

Revision ACL Reconstruction With Achilles Tendon Allograft Without InternalBrace Augmentation PROCEDURE

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.

Also known as: Revision ACL Reconstruction Without InternalBrace, ACL Revision Surgery Without InternalBrace Augmentation, Achilles Tendon Allograft ACL Revision Without Suture Tape Augmentation

No InternalBrace Augmentation

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• MRI-confirmed re-tear of the anterior cruciate ligament.
• Clinical knee instability.
• Patient-reported knee instability.
• Planned first revision anterior cruciate ligament reconstruction of the affected knee.
• Ability to undergo the standardized postoperative rehabilitation protocol.
• Written informed consent for study participation and use of study data.

You may not qualify if:

• Advanced associated knee lesions, such as pronounced meniscal tears or cartilage defects, requiring reconstruction or prolonged reduced weight bearing.
• Signs of infection.
• Advanced-stage osteoarthritis.
• Neuromuscular disease.
• Previous revision surgery on the affected knee.

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Medical University of Graz

Graz, Styria, 8036, Austria

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Study Officials

• Paul Ruckenstuhl, MD

  Department of Orthopaedics and Trauma, Medical University of Graz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Surgeons could not be blinded because of the nature of the intervention. Postoperative MRI scans were evaluated by two senior musculoskeletal radiologists, and disagreements were resolved by consensus.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants were randomized in a 1:1 ratio to revision ACL reconstruction using an Achilles tendon allograft with calcaneal bone block either with additional InternalBrace augmentation or without InternalBrace augmentation.

Study Record Dates

• First Submitted: April 27, 2026
• First Posted: May 4, 2026
• Study Start: February 1, 2017
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be available upon reasonable request after publication, with no predetermined end date.
• Access Criteria: Qualified researchers may request access by contacting the corresponding author. Requests will be reviewed based on scientific purpose, ethical approval where applicable, and compliance with applicable data protection requirements. Only de-identified data relevant to the approved request will be shared.

Locations

AU (1)