ACL Deficient KneeNCT06668155
ACLR: Isolated Autograft vs Allograft With Lateral Extra-articular Tenodesis
A study testing Autograft Group and Allograft with LET Group in people with ACL Deficient Knee, run by University of Alabama at Birmingham.
Trial summary
This study seeks to evaluate the utility of non-irradiated allograft tissue with lateral extra-articular tenodesis (LET) in the setting of anterior cruciate ligament reconstruction (ACLR). Read more about this study
- Who is it for?
- Ages 14 to 89 years
- Conditions the study is for
- ACL Deficient Knee
- What is being tested?
- Autograft Group and Allograft with LET Group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jan 2028to Jun 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 14 to 89 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- ACL deficient knee that are indicated for autograft ACLR
Who cannot join
- concomitant ligamentous injury that require surgery
- revision ACLR
- patients indicated for LET
- patients with previous knee surgery
- patients with cancer
- patients who are pregnant or nursing
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Isolated Autograft Anterior Cruciate Ligament Reconstruction Versus Allograft Anterior Cruciate Ligament Reconstruction With Lateral Extra-articular Tenodesis: A Randomized Controlled Trial
This study seeks to evaluate the utility of non-irradiated allograft tissue with lateral extra-articular tenodesis (LET) in the setting of anterior cruciate ligament reconstruction (ACLR).
Read the detailed description
While ACL injuries are among the most common sports medicine injuries treated arthroscopically, significant debate surrounds the choice of graft used in ACLR. While graft choice has been studied extensively, allografts have been shown to have a slightly increased risk of failure than autografts. However, these differences become less pronounced with non-irradiated allografts that have not undergone chemical processing or with slower rehabilitation timelines. Allografts also show poorer graft maturation on MRI. The use of allografts may avoid the donor site morbidities associated with autograft procedures such as pain, donor site weakness, and increased surgical duration. Previous studies have documented a high prevalence of extensor and flexor weakness following autograft ACLR, with deficits in flexor strength following hamstring autograft lasting up to 12 months and extensor strength deficits at 24 months following quadriceps tendon autograft ACLR. Limiting these morbidities may allow a more predictable return to activity and improve patient satisfaction following ACLR. Despite the benefits, concern remains regarding the use of allografts in higher demand patients. However, some studies of patients undergoing ACLR show similar results between allografts and autografts.
Despite advancements in ACLR techniques, retear rates and return-to-play rates remain unsatisfactory in specific populations. Recent investigations into the persistence of anterolateral rotatory laxity in patients have led to an increased focus on the role of the anterolateral complex for knee stability. Specifically, LET has grown in popularity in the setting of ACLR. Previous studies have demonstrated that the addition of LET may improve clinical outcomes when performed in conjunction with an ACLR, possibly by decreasing post-operative pivot shift, tibial translation, and retear rates.
No study to date has compared non-irradiated allografts augmented with LET to autografts for ACLR in a randomized controlled trial fashion. This proposed study aims to understand the utility of allografts in ACLR when combined with LET.
- Conditions
- ACL Deficient Knee
- Being tested
- Autograft Group, Allograft with LET Group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autograft GroupProcedure or surgery
If assigned the autograft group, the surgeon will choose either bone patella tendon bone (BPTB) or all soft tissue quadriceps tendon for the graft. The graft choice will be based upon surgeon preference.
Allograft with LET GroupProcedure or surgery
The allograft used will be a non-irradiated quadriceps tendon with bone plug allograft with a donor age less than 45 years.
| Study group | Role | What they receive |
|---|---|---|
| Assignment 0 | Active comparator | Not described Receives: Procedure: Autograft Group |
| Assignment 1 | Active comparator | Not described Receives: Procedure: Allograft with LET Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anterior Tibial Translation
KT-1000 measurement
Measured: 9 month post procedure
Quadricep and Hamstring Strength
Isometric Biodex Testing
Measured: 5-8 months post procedure and 9-15 months post procedure
Magnetic Resonance Imaging
Graft signal interpretation
Measured: 9-15 months post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2024
- Study startJan 2028 (estimated)
- Primary completionNov 2030 (estimated)
- Study completionJun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ACL Deficient KneeStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- * Assignment 0 represents the autograft group. If assigned the autograft group, the surgeon will choose either bone patella tendon bone (BPTB) or all soft tissue quadriceps tendon for the graft. The graft choice will be based upon surgeon preference. * Assignment 1 represents allograft with lateral extra-articular tenodesis LET group. The allograft used will be a non-irradiated quadriceps tendon with bone plug allograft with a donor age less than 45 years.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amit Momaya, University of Alabama at Birmingham
- Investigators
- Amit Momaya, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06668155
- Sponsor's protocol ID
- 300012655
- Other IDs
- UAB
- Status last verified
- Nov 2025
- First submitted
- 30 Oct 2024
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Isolated Autograft Anterior Cruciate Ligament Reconstruction Versus Allograft Anterior Cruciate Ligament Reconstruction With Lateral Extra-articular Tenodesis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06668155
- Acronym / sponsor ID
- 300012655
- Conditions
- ACL Deficient Knee
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Jan 2028 (estimated)
- Primary completion
- Nov 2030 (estimated)
- Study completion
- Jun 2031 (estimated)
- First posted
- 31 Oct 2024 (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 seeks to evaluate the utility of non-irradiated allograft tissue with lateral extra-articular tenodesis (LET) in the setting of anterior cruciate ligament reconstruction (ACLR).
Detailed description
While ACL injuries are among the most common sports medicine injuries treated arthroscopically, significant debate surrounds the choice of graft used in ACLR. While graft choice has been studied extensively, allografts have been shown to have a slightly increased risk of failure than autografts. However, these differences become less pronounced with non-irradiated allografts that have not undergone chemical processing or with slower rehabilitation timelines. Allografts also show poorer graft maturation on MRI. The use of allografts may avoid the donor site morbidities associated with autograft procedures such as pain, donor site weakness, and increased surgical duration. Previous studies have documented a high prevalence of extensor and flexor weakness following autograft ACLR, with deficits in flexor strength following hamstring autograft lasting up to 12 months and extensor strength deficits at 24 months following quadriceps tendon autograft ACLR. Limiting these morbidities may allow a more predictable return to activity and improve patient satisfaction following ACLR. Despite the benefits, concern remains regarding the use of allografts in higher demand patients. However, some studies of patients undergoing ACLR show similar results between allografts and autografts.
Despite advancements in ACLR techniques, retear rates and return-to-play rates remain unsatisfactory in specific populations. Recent investigations into the persistence of anterolateral rotatory laxity in patients have led to an increased focus on the role of the anterolateral complex for knee stability. Specifically, LET has grown in popularity in the setting of ACLR. Previous studies have demonstrated that the addition of LET may improve clinical outcomes when performed in conjunction with an ACLR, possibly by decreasing post-operative pivot shift, tibial translation, and retear rates.
No study to date has compared non-irradiated allografts augmented with LET to autografts for ACLR in a randomized controlled trial fashion. This proposed study aims to understand the utility of allografts in ACLR when combined with LET.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- * Assignment 0 represents the autograft group. If assigned the autograft group, the surgeon will choose either bone patella tendon bone (BPTB) or all soft tissue quadriceps tendon for the graft. The graft choice will be based upon surgeon preference. * Assignment 1 represents allograft with lateral extra-articular tenodesis LET group. The allograft used will be a non-irradiated quadriceps tendon with bone plug allograft with a donor age less than 45 years.
| Arm | Type | Receives |
|---|---|---|
| Assignment 0 | Active comparator | Procedure: Autograft Group |
| Assignment 1 | Active comparator | Procedure: Allograft with LET Group |
Who may qualify
- Ages
- 14 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- ACL deficient knee that are indicated for autograft ACLR
Key exclusion criteria (6 listed)
- concomitant ligamentous injury that require surgery
- revision ACLR
- patients indicated for LET
- patients with previous knee surgery
- patients with cancer
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 |
|---|---|---|
| Autograft GroupIf assigned the autograft group, the surgeon will choose either bone patella tendon bone (BPTB) or all soft tissue quadriceps tendon for the graft. The graft choice will be based upon surgeon preference. | Procedure or surgery | Assignment 0 |
| Allograft with LET GroupThe allograft used will be a non-irradiated quadriceps tendon with bone plug allograft with a donor age less than 45 years. | Procedure or surgery | Assignment 1 |
Primary outcome
Anterior Tibial Translation
Time frame: 9 month post procedure
KT-1000 measurement
Quadricep and Hamstring Strength
Time frame: 5-8 months post procedure and 9-15 months post procedure
Isometric Biodex Testing
Magnetic Resonance Imaging
Time frame: 9-15 months post procedure
Graft signal interpretation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
- Individual participant dataSharing planned: Undecided
Related trials for ACL Deficient Knee
Not yet recruitingObservational study
AI-Based Video Assessment of Anterior Knee Laxity
ACL - Anterior Cruciate Ligament Deficiency
Not yet recruitingObservational study
Measuring Knee Laxity and Pivot Shift in ACL-Deficient Patients
Anterior Cruciate Ligament (ACL) Tear
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.
Amit Momaya, MD principal investigator
University of Alabama at Birmingham
Questions about this trial
What is this clinical trial studying?
A study testing Autograft Group and Allograft with LET Group in people with ACL Deficient Knee, run by University of Alabama at Birmingham.
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 1 inclusion and 6 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: opening soon, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amit Momaya, MD (205-930-8339, momaya@uab.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anterior Tibial Translation (time frame: 9 month post procedure). The study lists 3 primary outcomes in all. 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 26 Nov 2025.