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Achilles Allograft With or Without InternalBrace for ACL Revision Surgery

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07564336
Acronym
ACL-AlloRev
Enrollment
32
Registered
2026-05-04
Start date
2017-02-01
Completion date
2021-09-30
Last updated
2026-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anterior Cruciate Ligament Graft Failure, Anterior Cruciate Ligament Injury, Anterior Cruciate Ligament Rupture, 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

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.

Detailed description

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.

Interventions

PROCEDURERevision 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.

PROCEDURERevision 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

Medical University of Graz
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

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.

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
International Knee Documentation Committee ScorePreoperative baseline to 13 months after surgeryThe 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

MeasureTime frameDescription
Lysholm Knee Questionnaire ScorePreoperative baseline to 13 months after surgeryThe 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.
Tegner Activity Scale ScorePreoperative baseline to 13 months after surgeryThe 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.
Knee Injury and Osteoarthritis Outcome ScorePreoperative baseline to 13 months after surgeryThe 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.
Short Form-36 Physical Component Summary ScorePreoperative baseline to 13 months after surgeryThe 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.
Short Form-36 Mental Component Summary ScorePreoperative baseline to 13 months after surgeryThe 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.
MRI Assessment of ACL Allograft Tightness13 months after surgeryPostoperative magnetic resonance imaging was used to assess anterior cruciate ligament allograft tightness. Grafts were categorized as tight, elongated, or insufficient.
MRI Assessment of Femoral and Tibial Tunnel Size13 months after surgeryPostoperative magnetic resonance imaging was used to measure femoral and tibial tunnel size after revision anterior cruciate ligament reconstruction. Tunnel size was measured in millimeters.

Countries

Austria

Contacts

PRINCIPAL_INVESTIGATORPaul Ruckenstuhl, MD

Department of Orthopaedics and Trauma, Medical University of Graz

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 11, 2026