Anterior Cruciate Ligament InjuryACL-AlloRevNCT07564336
Achilles Allograft With or Without InternalBrace for ACL Revision Surgery
A study testing Revision ACL Reconstruction With Achilles Tendon Allograft and InternalBrace Augmentation and Revision ACL Reconstruction With Achilles Tendon Allograft Without InternalBrace Augmentation in people with Anterior Cruciate Ligament Injury and Anterior Cruciate Ligament Rupture, run by Medical University of Graz at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Anterior Cruciate Ligament Injury, Anterior Cruciate Ligament Rupture, Anterior Cruciate Ligament Graft Failure
- What is being tested?
- Revision ACL Reconstruction With Achilles Tendon Allograft and InternalBrace Augmentation and Revision ACL Reconstruction With Achilles Tendon Allograft Without InternalBrace Augmentation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteAustria
- Study dates
- 1 Feb 2017to 30 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Achilles Tendon Allografts With and Without InternalBrace Augmentation for Anterior Cruciate Ligament Revision Surgery: A Randomized Controlled Pilot Trial
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.
Read the 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.
- Conditions
- Anterior Cruciate Ligament Injury, Anterior Cruciate Ligament Rupture, Anterior Cruciate Ligament Graft Failure, Knee Instability
- Being tested
- Revision ACL Reconstruction With Achilles Tendon Allograft and InternalBrace Augmentation, Revision ACL Reconstruction With Achilles Tendon Allograft Without InternalBrace Augmentation
- 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
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Revision ACL Reconstruction With Achilles Tendon Allograft and InternalBrace AugmentationProcedure or surgery
Also called Revision ACL Reconstruction With InternalBrace, ACL Revision Surgery With InternalBrace Augmentation, Achilles Tendon Allograft ACL Revision With Suture Tape 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.
Revision ACL Reconstruction With Achilles Tendon Allograft Without InternalBrace AugmentationProcedure or surgery
Also called Revision ACL Reconstruction Without InternalBrace, ACL Revision Surgery Without InternalBrace Augmentation, Achilles Tendon Allograft ACL Revision Without Suture Tape 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Revision ACL Reconstruction With Achilles Tendon Allograft Without InternalBrace Augmentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Preoperative baseline to 13 months after surgery
Secondary outcomes (7)
Lysholm Knee Questionnaire Score
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.
Measured: Preoperative baseline to 13 months after surgery
Tegner Activity Scale Score
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.
Measured: Preoperative baseline to 13 months after surgery
Knee Injury and Osteoarthritis Outcome Score
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.
Measured: Preoperative baseline to 13 months after surgery
Short Form-36 Physical Component Summary Score
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.
Measured: Preoperative baseline to 13 months after surgery
Short Form-36 Mental Component Summary Score
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.
Measured: Preoperative baseline to 13 months after surgery
MRI Assessment of ACL Allograft Tightness
Postoperative magnetic resonance imaging was used to assess anterior cruciate ligament allograft tightness. Grafts were categorized as tight, elongated, or insufficient.
Measured: 13 months after surgery
MRI Assessment of Femoral and Tibial Tunnel Size
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.
Measured: 13 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2026
- Study start1 Feb 2017
- Primary completion30 Sep 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament InjuryStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul Ruckenstuhl, MD, Principal investigator, Department of Orthopaedics and Trauma, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07564336
- Sponsor's protocol ID
- 29-201 ex 16/17
- Acronym
- ACL-AlloRev
- Status last verified
- May 2026
- First submitted
- 27 Apr 2026
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in the publication will be shared upon reasonable request. Shared data may include baseline characteristics, group allocation, clinical outcome scores, patient-reported outcome measures, health-related quality-of-life scores, and MRI assessment data.
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Achilles Tendon Allografts With and Without InternalBrace Augmentation for Anterior Cruciate Ligament Revision Surgery: A Randomized Controlled Pilot Trial
- ClinicalTrials.gov ID
- NCT07564336
- Acronym / sponsor ID
- ACL-AlloRev / 29-201 ex 16/17
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 4 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| InternalBrace Augmentation | Experimental | Procedure: Revision ACL Reconstruction With Achilles Tendon Allograft and InternalBrace AugmentationParticipants 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. |
| No InternalBrace Augmentation | Active comparator | Procedure: Revision ACL Reconstruction With Achilles Tendon Allograft Without InternalBrace AugmentationParticipants 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Revision ACL Reconstruction With Achilles Tendon Allograft and InternalBrace AugmentationAlso: Revision ACL Reconstruction With InternalBrace, ACL Revision Surgery With InternalBrace Augmentation, Achilles Tendon Allograft ACL Revision With Suture Tape AugmentationRevision 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 or surgery | InternalBrace Augmentation |
| Revision ACL Reconstruction With Achilles Tendon Allograft Without InternalBrace AugmentationAlso: Revision ACL Reconstruction Without InternalBrace, ACL Revision Surgery Without InternalBrace Augmentation, Achilles Tendon Allograft ACL Revision Without Suture Tape AugmentationRevision 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. | Procedure or surgery | No InternalBrace Augmentation |
Primary outcome
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.
7 secondary outcomes
Lysholm Knee Questionnaire Score
Time frame: Preoperative baseline to 13 months after surgery
Tegner Activity Scale Score
Time frame: Preoperative baseline to 13 months after surgery
Knee Injury and Osteoarthritis Outcome Score
Time frame: Preoperative baseline to 13 months after surgery
Short Form-36 Physical Component Summary Score
Time frame: Preoperative baseline to 13 months after surgery
Short Form-36 Mental Component Summary Score
Time frame: Preoperative baseline to 13 months after surgery
MRI Assessment of ACL Allograft Tightness
Time frame: 13 months after surgery
MRI Assessment of Femoral and Tibial Tunnel Size
Time frame: 13 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in the publication will be shared upon reasonable request. Shared data may include baseline characteristics, group allocation, clinical outcome scores, patient-reported outcome measures, health-related quality-of-life scores, and MRI assessment data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Ruckenstuhl, MD principal investigator
Department of Orthopaedics and Trauma, Medical University of Graz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Revision ACL Reconstruction With Achilles Tendon Allograft and InternalBrace Augmentation and Revision ACL Reconstruction With Achilles Tendon Allograft Without InternalBrace Augmentation in people with Anterior Cruciate Ligament Injury and Anterior Cruciate Ligament Rupture, run by Medical University of Graz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Knee Documentation Committee Score (time frame: Preoperative baseline to 13 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.