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ACLR: Isolated Autograft vs Allograft With Lateral Extra-articular Tenodesis

Isolated Autograft Anterior Cruciate Ligament Reconstruction Versus Allograft Anterior Cruciate Ligament Reconstruction With Lateral Extra-articular Tenodesis: A Randomized Controlled Trial

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06668155
Enrollment
60
Registered
2024-10-31
Start date
2028-01-31
Completion date
2031-06-30
Last updated
2025-11-26

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

Conditions

ACL Deficient Knee

Brief 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).

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.

Interventions

PROCEDUREAutograft 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.

PROCEDUREAllograft with LET Group

The allograft used will be a non-irradiated quadriceps tendon with bone plug allograft with a donor age less than 45 years.

Sponsors

University of Alabama at Birmingham
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
14 Years to 89 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Anterior Tibial Translation9 month post procedureKT-1000 measurement
Quadricep and Hamstring Strength5-8 months post procedure and 9-15 months post procedureIsometric Biodex Testing
Magnetic Resonance Imaging9-15 months post procedureGraft signal interpretation

Contacts

Primary ContactAmit Momaya, MD
momaya@uab.edu205-930-8339

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026