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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16-60
SponsorUniversity of Alabama at Birmingham

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

undergoing multi ligamentous reconstruction (PCL, MCL, or PLC)

revision ACL reconstruction

neuromuscular disorders

contralateral ACL injury

Trial design

Design model

Parallel

Treatments tested in this trial

  • Bone-patellar Tendon-bone (BTB)

    Procedure/Surgery

    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/Surgery

    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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: ACLR BTBActive comparator 1 intervention
Group B: ACLR BTB with LETExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Change in operative-leg lean mass (LM)

Time frame
Baseline to 9 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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