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

NCT ID: NCT06668155

Last Updated: 2025-11-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2028-01-31
• Study Completion Date: 2031-06-30

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.

Conditions

ACL Deficient Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Assignment 0

Group Type: ACTIVE_COMPARATOR

Autograft Group

Intervention Type: 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.

Assignment 1

Group Type: ACTIVE_COMPARATOR

Allograft with LET Group

Intervention Type: PROCEDURE

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

Interventions

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.

Intervention Type: PROCEDURE

Allograft 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Amit Momaya

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amit Momaya, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Central Contacts

Amit Momaya, MD

Role: CONTACT

momaya@uab.edu

205-930-8339

Other Identifiers

UAB

Identifier Type: OTHER

Identifier Source: secondary_id

300012655

Identifier Type: -

Identifier Source: org_study_id