Lateral Extra-Articular Tenodesis for ACL Reconstruction Recovery

AM
Overseen ByAmit Momaya, MD
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: University of Alabama at Birmingham
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

AM

Amit Moma, MD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

This trial is for adults up to age 60 with a recent ACL injury (within 6 weeks) who are scheduled for their first bone-patellar tendon-bone ACL reconstruction, with or without an added LET procedure. People with nerve/muscle disorders, previous ACL surgeries, injuries in the other knee, or those pregnant/nursing cannot join.

Inclusion Criteria

My injury happened within the last 6 weeks.
I am 60 or younger, fully grown, and scheduled for my first BTB ACL reconstruction.
I have a recent ACL injury.

Exclusion Criteria

I have a neuromuscular disorder.
I am having a repeat ACL reconstruction surgery.
I have had an ACL injury in my other knee.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Initial Recovery

Participants undergo Anterior Cruciate Ligament Reconstruction (ACLR) with or without Lateral Extra-Articular Tenodesis (LET)

1-2 weeks

Postoperative Rehabilitation

Participants engage in rehabilitation to recover lower-extremity lean mass following surgery

9 months

Follow-up

Participants are monitored for lower-extremity lean mass recovery and safety post-treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Bone-patellar Tendon-bone (BTB) Anterior Cruciate Ligament Reconstruction
  • Lateral Extra-Articular Tenodesis (LET)

Trial Overview

The study compares two surgical approaches: standard bone-patellar tendon-bone (BTB) ACL reconstruction versus BTB plus Lateral Extra-Articular Tenodesis (LET), to see which helps leg muscle mass recover better after surgery.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: ACLR BTB with LETExperimental Treatment2 Interventions
Group II: ACLR BTBActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials
1,677
Recruited
2,458,000+