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Completed

NCT Number: NCT07564336

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of Graz

Graz, Styria, 8036, Austria

About this study

Anterior cruciate ligament revision surgery remains challenging and may have less predictable outcomes than primary ACL reconstruction. In revision cases, prior bone tunnels and bone defects can complicate graft fixation. Achilles tendon allografts with calcaneal bone blocks provide a reliable graft configuration and may help fill pre-existing bone defects during a one-stage revision procedure. InternalBrace augmentation is intended to provide additional support to the reconstructed ligament during the healing period, but clinical evidence for its use with allograft ACL revision surgery is limited.

This prospective, randomized controlled pilot study enrolled patients from February 2017 to September 2020 at the Medical University of Graz. Eligible participants had MRI-confirmed re-tear of the ACL graft and clinical and patient-reported knee instability. Patients with advanced associated lesions requiring reconstruction or prolonged restricted weight bearing, signs of infection, advanced osteoarthritis, or neuromuscular disease were excluded. For all included participants, the procedure was the first revision surgery on the affected knee. The study was approved by the Ethics Committee of the Medical University of Graz, and written informed consent was obtained before participation.

All participants underwent revision ACL reconstruction using an Achilles tendon allograft with a calcaneal bone block. Participants were randomized in a 1:1 ratio to receive either additional InternalBrace augmentation or no InternalBrace augmentation. The InternalBrace group received a non-resorbable polyethylene FiberTape fixed separately and independently from the ACL graft. Apart from the additional InternalBrace fixation in one group, the surgical technique and postoperative rehabilitation protocol were the same for all participants.

Clinical and patient-reported outcomes were assessed preoperatively and at 6 weeks, 12 weeks, 6 months, and 13 months after surgery. Outcome measures included the International Knee Documentation Committee score, Lysholm Knee Questionnaire, Tegner Activity Scale, Knee Injury and Osteoarthritis Outcome Score, and Short Form-36. MRI scans were performed before surgery and 13 months after surgery to assess graft appearance, graft tightness, graft signal, ligament signs at the femoral and tibial tunnel insertions, and tunnel size.

The final analyzed study population included 30 participants, with 16 participants in the InternalBrace group and 14 participants in the non-InternalBrace group. Overall, clinical and patient-reported outcomes improved during follow-up. At the final 13-month follow-up, there were no clinically relevant differences between the InternalBrace and non-InternalBrace groups. Postoperative MRI showed elongated or insufficient ACL allografts in 15 of 30 participants, without significant differences between groups. The study concluded that ACL revision surgery using Achilles tendon allografts with bone blocks resulted in improved clinical outcomes at 13 months, but additional InternalBrace augmentation did not improve objective or subjective outcomes in this pilot trial.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Other names: Revision ACL Reconstruction With InternalBrace, ACL Revision Surgery With InternalBrace Augmentation, Achilles Tendon Allograft ACL Revision With Suture Tape 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.

Other names: Revision ACL Reconstruction Without InternalBrace, ACL Revision Surgery Without InternalBrace Augmentation, Achilles Tendon Allograft ACL Revision Without Suture Tape Augmentation

Primary outcomes

  1. International Knee Documentation Committee Score

    Time frame: Preoperative baseline to 13 months after surgery

    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.

Secondary outcomes

  1. Lysholm Knee Questionnaire Score

    Time frame: Preoperative baseline to 13 months after surgery

    The Lysholm Knee Questionnaire was used to assess knee symptoms and functional limitations after revision anterior cruciate ligament reconstruction. Scores range from 0 to 100, with higher scores indicating better knee function.

  2. Tegner Activity Scale Score

    Time frame: Preoperative baseline to 13 months after surgery

    The Tegner Activity Scale was used to assess participant activity level after revision anterior cruciate ligament reconstruction. Scores range from 0 to 10, with higher scores indicating a higher activity level.

  3. Knee Injury and Osteoarthritis Outcome Score

    Time frame: Preoperative baseline to 13 months after surgery

    The Knee Injury and Osteoarthritis Outcome Score was used to assess knee-related pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life. Subscale scores range from 0 to 100, with higher scores indicating better outcomes.

  4. Short Form-36 Physical Component Summary Score

    Time frame: Preoperative baseline to 13 months after surgery

    The Short Form-36 Physical Component Summary score was used to assess physical health-related quality of life after revision anterior cruciate ligament reconstruction. Scores range from 0 to 100, with higher scores indicating better physical health-related quality of life.

  5. Short Form-36 Mental Component Summary Score

    Time frame: Preoperative baseline to 13 months after surgery

    The Short Form-36 Mental Component Summary score was used to assess mental health-related quality of life after revision anterior cruciate ligament reconstruction. Scores range from 0 to 100, with higher scores indicating better mental health-related quality of life.

  6. MRI Assessment of ACL Allograft Tightness

    Time frame: 13 months after surgery

    Postoperative magnetic resonance imaging was used to assess anterior cruciate ligament allograft tightness. Grafts were categorized as tight, elongated, or insufficient.

  7. MRI Assessment of Femoral and Tibial Tunnel Size

    Time frame: 13 months after surgery

    Postoperative magnetic resonance imaging was used to measure femoral and tibial tunnel size after revision anterior cruciate ligament reconstruction. Tunnel size was measured in millimeters.

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Registry information

Official study title

Achilles Tendon Allografts With and Without InternalBrace Augmentation for Anterior Cruciate Ligament Revision Surgery: A Randomized Controlled Pilot Trial

Acronym: ACL-AlloRev

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
May 4, 2026
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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