Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06668155

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

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).

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Age range

14 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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 can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 and study plan

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.

Primary outcomes

  1. Anterior Tibial Translation

    Time frame: 9 month post procedure

    KT-1000 measurement

  2. Quadricep and Hamstring Strength

    Time frame: 5-8 months post procedure and 9-15 months post procedure

    Isometric Biodex Testing

  3. Magnetic Resonance Imaging

    Time frame: 9-15 months post procedure

    Graft signal interpretation

Study contacts

Contact information is provided by the study sponsor or research team.

Amit Momaya, MD

CONTACT

[email protected]

205-930-8339

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study title

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

Important dates

Study start
2028
Primary completion
2030
Study completion
2031
First posted
Oct 31, 2024
Registry last updated
Nov 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.