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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT07777458
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Anterior Cruciate Ligament Reconstruction (ACLR)

Eligibility Criteria

Sex
ALL
Age
16 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Bone-patellar Tendon-bone (BTB) — PROCEDURE
    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.
  • Bone-patellar Tendon-bone (BTB) and Lateral Extra-Articular Tenodesis (LET) — PROCEDURE
    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 Details

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.

Key Dates

First listed
Aug 20, 2026
Start date
Oct 31, 2026
Status verified
Aug 2026
Primary completion
Aug 31, 2031
Completion
Aug 31, 2031

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: ACLR BTB
    Participants undergoing Anterior Cruciate Ligament Reconstruction (ACLR) will receive Bone-patellar Tendon-bone (BTB)
  • Experimental: ACLR BTB with LET
    Participants undergoing Anterior Cruciate Ligament Reconstruction (ACLR) will receive both Bone-patellar Tendon-bone (BTB) and Lateral Extra-Articular Tenodesis (LET)

Primary Outcome Measure

Change in operative-leg lean mass (LM) [ Time Frame: Baseline to 9 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35233
Amit Momaya, MD
[email protected]
(205) 930-8339
Amit Momaya, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Birmingham, AL

By research site
University of Alabama at Birmingham· Birmingham, AL