Anterior Cruciate Ligament Reconstruction (ACLR)NCT07777458
The Effect of Lateral Extra-Articular Tenodesis on Lower-Extremity Lean Mass Recovery Following Anterior Cruciate Ligament Reconstruction
A study testing Bone-patellar Tendon-bone (BTB) and Bone-patellar Tendon-bone (BTB) and Lateral Extra-Articular Tenodesis (LET) in people with Anterior Cruciate Ligament Reconstruction (ACLR), run by University of Alabama at Birmingham at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 16 to 60 years
- Conditions the study is for
- Anterior Cruciate Ligament Reconstruction (ACLR)
- What is being tested?
- Bone-patellar Tendon-bone (BTB) and Bone-patellar Tendon-bone (BTB) and Lateral Extra-Articular Tenodesis (LET)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2026to Aug 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Amit Momaya, MD, (205) 930-8339, amomaya@uabmc.edu
Amit Momaya, MD
About this study
Official title: The Effect of Lateral Extra-Articular Tenodesis on Lower-Extremity Lean Mass Recovery Following Anterior Cruciate Ligament Reconstruction: A Randomized Controlled 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.
- Being tested
- Bone-patellar Tendon-bone (BTB), Bone-patellar Tendon-bone (BTB) and Lateral Extra-Articular Tenodesis (LET)
- Keywords
- Lateral Extra-Articular Tenodesis (LET), Bone-Patellar Tendon-Bone (BTB), Anterior Cruciate Ligament Reconstruction (ACLR)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone-patellar Tendon-bone (BTB)Procedure or 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 or 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.
| Study group | Role | What they receive |
|---|---|---|
| ACLR BTB | Active comparator | Participants undergoing Anterior Cruciate Ligament Reconstruction (ACLR) will receive Bone-patellar Tendon-bone (BTB) Receives: Procedure: Bone-patellar Tendon-bone (BTB) |
| ACLR BTB with LET | Experimental | Participants undergoing Anterior Cruciate Ligament Reconstruction (ACLR) will receive both Bone-patellar Tendon-bone (BTB) and Lateral Extra-Articular Tenodesis (LET) Receives: Procedure: Bone-patellar Tendon-bone (BTB); Procedure: Bone-patellar Tendon-bone (BTB) and Lateral Extra-Articular Tenodesis (LET) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in operative-leg lean mass (LM)
Measured: Baseline to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study startNov 2026 (estimated)
- Primary completionAug 2031 (estimated)
- Study completionAug 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anterior Cruciate Ligament Reconstruction (ACLR)Studies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amit Momaya, University of Alabama at Birmingham
- Investigators
- Amit Moma, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07777458
- Sponsor's protocol ID
- IRB-300017229
- Other IDs
- Pending
- Status last verified
- Oct 2026
- First submitted
- 17 Aug 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Guarino A, Farinelli L, Iacono V, Screpis D, Piovan G, Rizzo M, Mariconda M, Zorzi C. Lateral extra-articular tenodesis and anterior cruciate ligament reconstruction in young patients: clinical results and return to sport. Orthop Rev (Pavia). 2022 Apr 25;14(2):33696. doi: 10.52965/001c.33696. eCollection 2022.
PubMed 35774923
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Lateral Extra-Articular Tenodesis on Lower-Extremity Lean Mass Recovery Following Anterior Cruciate Ligament Reconstruction: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07777458
- Acronym / sponsor ID
- IRB-300017229
- Keywords
- Lateral Extra-Articular Tenodesis (LET), Bone-Patellar Tendon-Bone (BTB), Anterior Cruciate Ligament Reconstruction (ACLR)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Aug 2031 (estimated)
- Study completion
- Aug 2031 (estimated)
- First posted
- 20 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACLR BTB | Active comparator | Procedure: Bone-patellar Tendon-bone (BTB)Participants undergoing Anterior Cruciate Ligament Reconstruction (ACLR) will receive Bone-patellar Tendon-bone (BTB) |
| ACLR BTB with LET | Experimental | Procedure: Bone-patellar Tendon-bone (BTB), Procedure: Bone-patellar Tendon-bone (BTB) and Lateral Extra-Articular Tenodesis (LET)Participants undergoing Anterior Cruciate Ligament Reconstruction (ACLR) will receive both Bone-patellar Tendon-bone (BTB) and Lateral Extra-Articular Tenodesis (LET) |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- undergoing multi ligamentous reconstruction (PCL, MCL, or PLC)
- revision ACL reconstruction
- neuromuscular disorders
- contralateral ACL injury
- pregnant or nursing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bone-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. | Procedure or surgery | ACLR BTB, ACLR BTB with LET |
| Bone-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. | Procedure or surgery | ACLR BTB with LET |
Primary outcome
Change in operative-leg lean mass (LM)
Time frame: Baseline to 9 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Background: PubMed 35774923Guarino A, Farinelli L, Iacono V, Screpis D, Piovan G, Rizzo M, Mariconda M, Zorzi C. Lateral extra-articular tenodesis and anterior cruciate ligament reconstruction in young patients: clinical results and return to sport. Orthop Rev (Pavia). 2022 Apr 25;14(2):33696. doi: 10.52965/001c.33696. eCollection 2022.
- Goddard, M., Salmon, L., Waller, A., Papapetros, E., \& Pinczewski, L. A. (2013). Incidence of graft rupture 15 years after bilateral anterior cruciate ligament reconstructions: a case-control study. The bone \& joint journal, 95-B(6), 798-802.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amit Moma, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bone-patellar Tendon-bone (BTB) and Bone-patellar Tendon-bone (BTB) and Lateral Extra-Articular Tenodesis (LET) in people with Anterior Cruciate Ligament Reconstruction (ACLR), run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amit Momaya, MD ((205) 930-8339, amomaya@uabmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in operative-leg lean mass (LM) (time frame: Baseline to 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07777458, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.