ACLR: Isolated Autograft vs Allograft With Lateral Extra-articular Tenodesis
ACL Deficient Knee
What this study involves
The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.
- Study type
- Interventional
- Phase
- Not applicable
- Age range
- 14 years - 89 years
- Sex eligible
- All sexes
- Healthy volunteers
- Not accepted
- Participants
- 60 Estimated
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
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 full 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.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
Inclusion Criteria:
- ACL deficient knee that are indicated for autograft ACLR
Exclusion Criteria:
- 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
Treatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Random assignment
- Masking
- No masking
Assignment 0
Not reported in this registry record.
Procedure: Autograft Group
Assignment 1
Not reported in this registry record.
Procedure: Allograft with LET Group
Autograft Group PROCEDURE
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 Group PROCEDURE
The allograft used will be a non-irradiated quadriceps tendon with bone plug allograft with a donor age less than 45 years.
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
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
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (0)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
No locations are listed. Use the official study contact.
Study team and timeline
- Lead sponsor
- University of Alabama at Birmingham
- Study start
- 2028-01 Estimated
- Primary completion
- 2030-11 Estimated
- Study completion
- 2031-06 Estimated
- First posted
- Oct 31, 2024 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
Official study title
Isolated Autograft Anterior Cruciate Ligament Reconstruction Versus Allograft Anterior Cruciate Ligament Reconstruction With Lateral Extra-articular Tenodesis: A Randomized Controlled Trial
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026