The Effect of Lateral Extra-Articular Tenodesis on Lower-Extremity Lean Mass Recovery Following Anterior Cruciate Ligament Reconstruction

The Effect of Lateral Extra-Articular Tenodesis on Lower-Extremity Lean Mass Recovery Following Anterior Cruciate Ligament Reconstruction: A Randomized Controlled Trial

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07777458

Enrollment

Registered

2026-08-20

Start date

2026-10-01

Completion date

2031-08-01

Last updated

2026-08-20

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

Conditions

Anterior Cruciate Ligament Reconstruction (ACLR)

Keywords

Lateral Extra-Articular Tenodesis (LET), Bone-Patellar Tendon-Bone (BTB), Anterior Cruciate Ligament Reconstruction (ACLR)

Brief summary

The purpose of this study is to determine whether the addition of Lateral Extra-Articular Tenodesis (LET) influences postoperative lower-extremity LM recovery following bone-patellar tendon-bone (BTB) Anterior Cruciate Ligament Reconstruction (ACLR). We hypothesize that patients undergoing ACLR BTB with LET will demonstrate greater loss of operative-leg LM at 9 months postoperatively compared with patients undergoing isolated ACLR BTB.

Interventions

PROCEDUREBone-patellar Tendon-bone (BTB)

Harvested with bone on both ends of soft tissue. A portion of the patient's patellar tendon, along with bone plugs from the patella and tibial tubercle, is harvested and used to reconstruct the torn ACL through bone tunnels created in the tibia and femur.

PROCEDUREBone-patellar Tendon-bone (BTB) and Lateral Extra-Articular Tenodesis (LET)

A strip of the iliotibial band on the outside of the knee is used to provide additional stability and reduce abnormal rotational movement following ACL reconstruction.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

16 Years to 60 Years

Healthy volunteers

Inclusion criteria

* Skeletally mature patients less than or equal to 60 years of age with ACL insufficiency scheduled to undergo primary BTB ACL reconstruction with or without LET. * Patients presenting with acute ACL injuries. Patients presenting with acute ACL injuries will be eligible for enrollment. * Acute injuries will be defined as injuries occurring within 6 weeks of presentation.

Exclusion criteria

* undergoing multi ligamentous reconstruction (PCL, MCL, or PLC) * revision ACL reconstruction * neuromuscular disorders * contralateral ACL injury * pregnant or nursing * unable to read or write in English * possessing a high likelihood of remaining non-compliant * desire to return to sport prior to 6 months.

Design outcomes

Primary

Measure	Time frame
Change in operative-leg lean mass (LM)	Baseline to 9 months

Countries

United States

Contacts

CONTACTAmit Momaya, MD

amomaya@uabmc.edu(205) 930-8339

PRINCIPAL_INVESTIGATORAmit Moma, MD

University of Alabama at Birmingham

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 21, 2026