ACL InjuryPALLETNCT04825587
The Pediatric ALL Evaluation and Trial
A study testing Patients will be randomized into one of two study arms: (1) concomitant ACL and ALL reconstruction or (2) ACL reconstruction alone. in people with ACL Injury and ACL Tear, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.
Trial summary
The overall aim of this multicenter RCT is to determine whether concomitant ALL reconstruction in children undergoing and ACL reconstruction will longitudinally result in a lower rate of graft failure than ACL reconstruction alone. Read more about this study
- Who is it for?
- Ages Up to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- ACL Injury, ACL Tear
- What is being tested?
- Patients will be randomized into one of two study arms: (1) concomitant ACL and ALL reconstruction or (2) ACL reconstruction alone.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Apr 2021to 1 Apr 2030
- 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 Up to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age 18 and under
- Surgery within 6 months of injury
- Undergoing primary ACL reconstruction without previous injury or surgery
- Quadriceps tendon autograft ACL reconstruction
- Closing or closed physes
Who cannot join
- Over 18 years old
- Previous ipsilateral knee injury or surgery
- Neuromuscular or developmental disorders affecting knee anatomy, cognition, or neuromuscular control
- Other concomitant ligament reconstruction aside from the ALL (i.e., MCL, PCL, PLC)
- Revision ACL reconstruction
- ACL reconstruction with graft other than quadriceps tendon
Show all 9Show fewer
- IT band (modified MacIntosh) ACL reconstruction
- A cartilage lesion requiring anything more than debridement
- Open physes requiring both femoral and tibial physeal-sparing technique
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, 1 recruiting
- Recruiting
Lurie Children's Hospital
Chicago, Illinois, 60611
Amanda Kass, (312) 227-1267, akass@luriechildrens.org
Neeraj Patel, MD
About this study
Official title: The Pediatric ALL Evaluation and Trial: A Randomized, Controlled Trial
The overall aim of this multicenter RCT is to determine whether concomitant ALL reconstruction in children undergoing and ACL reconstruction will longitudinally result in a lower rate of graft failure than ACL reconstruction alone.
Read the detailed description
Studies have reported a rising incidence of anterior cruciate ligament (ACL) injuries in children and adolescents. Beck et al reported a 2.3% annual increase between 1994 and 2013. In New York State, the rate of pediatric ACL reconstruction climbed from 17.6/100,000 in 1990 to 50.9/100,000 by 2009. Other reports echo these findings. After ACL reconstruction, children are known to be at a higher risk for complications than adults. For example, while the rate of postoperative graft failure in adults was 3% to 4% in large national registries, as many as 12% to 19% of pediatric patients may sustain graft rupture. This can have substantial medical, financial, and psychosocial implications on the patient and family. Additionally, the results of revision ACL reconstruction are, on average, worse than after index surgery. Exploration of treatments that may lower the rate of re-injury is paramount in this population that is at highest risk.
In the adult population, a growing number of studies have suggested that concomitant reconstruction of the anterolateral ligament (ALL) with the ACL may help lower this risk. The ALL was likely first characterized in 1879 by the French surgeon Segond, who commented on the presence of a "pearly, resistant, fibrous band" in the lateral aspect of the knee. However, only in 2012 was the structure given the name "anterolateral ligament" after it was consistently identified in cadaveric specimens. Some studies suggest that the ALL is damaged during anterior cruciate ligament (ACL) injury, implying that it may supplement the ACL in providing rotational and translational stability. Biomechanical studies have confirmed that it likely plays a role in rotational stability.
A number of ALL reconstruction techniques have been developed with the hope of lowering the rate of re-injury after ACL reconstruction. Early literature in the adult population suggests that this may indeed be the case. Early case series suggested that concomitant ALL reconstruction resulted in high rates of return to sport and a low ACL graft failure rate (2.6%). Comparative retrospective studies in adults suggest better patient reported outcome scores, meniscal repair healing, and rates of return to sports when the ALL is reconstructed with the ACL compared to isolated ACL reconstruction. Finally, a prospective cohort study of adults reported that hamstring autograft ACL reconstruction with concomitant ALL reconstruction resulted in 3.1 times lower odds of graft failure than isolated hamstring ACL reconstruction and 2.5 times lower odds of failure than isolated patellar tendon ACL reconstruction.
The hypotheses to be tested in this study have never been evaluated in the pediatric population. Furthermore, the proposed investigation is a randomized controlled trial, which will allow it to provide novel results with high-level evidence. The results of such a study have the potential to change practice in a meaningful, tangible way and affect the outcomes of thousands of children annually. In addition to the medical and functional impact, there could also be important financial and psychosocial implications.
- Conditions
- ACL Injury, ACL Tear
- Being tested
- Patients will be randomized into one of two study arms: (1) concomitant ACL and ALL reconstruction or (2) ACL reconstruction alone.
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients will be randomized into one of two study arms: (1) concomitant ACL and ALL reconstruction or (2) ACL reconstruction alone.Procedure or surgery
By randomizing patients into one of two study arms: (1) concomitant ACL and ALL reconstruction or (2) ACL reconstruction alone, following statistical analysis, we hope to determine whether concomitant ALL reconstruction in children undergoing and ACL reconstruction will longitudinally result in a lower rate of graft failure than ACL reconstruction alone.
| Study group | Role | What they receive |
|---|---|---|
| Concomitant ACL and ALL reconstruction | Experimental | The participant will undergo both the ACL and ALL reconstruction surgery. Receives: Procedure: Patients will be randomized into one of two study arms: (1) concomitant ACL and ALL reconstruction or (2) ACL reconstruction alone. |
| ACL reconstruction alone | Experimental | The participant will undergo only ACL reconstruction surgery. Receives: Procedure: Patients will be randomized into one of two study arms: (1) concomitant ACL and ALL reconstruction or (2) ACL reconstruction alone. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Graft failure
To determine whether concomitant ALL reconstruction in children undergoing and ACL reconstruction will longitudinally result in a lower rate of graft failure (confirmed graft re-tear or asymmetric, increased pivot shift) than ACL reconstruction alone.
Measured: Complete when all 780 participants have been recruited, received an intervention and have been followed for data collection for up to 5 years.
Secondary outcomes (2)
Complications of ALL reconstruction
To determine the rate and severity of complications related specifically to ALL reconstruction in children.
Measured: Complete when all 780 participants have been recruited, received an intervention and have been followed for data collection for up to 5 years.
Patient reported outcome measures
To collect and compare patient reported outcome (PRO) scores (as measured by the Pedi-IKDC, Lysholm, HSS Pedi-FABS, and PROMIS surveys) in children undergoing ACL reconstruction alone, and children undergoing combined ACL and ALL reconstruction.
Measured: Complete when all 780 participants have been recruited, received an intervention and have been followed for data collection for up to 5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start28 Apr 2021
- Primary completion1 Apr 2030 (estimated)
- Study completion1 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ACL InjuryStudies of the same condition, open and under way.
- 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
- Model description
- The overall aim of this multicenter RCT is to determine whether concomitant ALL reconstruction in children undergoing and ACL reconstruction will result in a lower rate of graft failure than ACL reconstruction alone.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital of Philadelphia, Baylor College of Medicine, UCSF Benioff Children's Hospital - San Francisco
- Responsible party
- Principal investigator, Neeraj Patel, MD, Ann & Robert H Lurie Children's Hospital of Chicago
- Investigators
- Neeraj Patel, MD, Principal investigator, Ann & Robert H Lurie Children's Hospital of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04825587
- Sponsor's protocol ID
- 2020-3610
- Acronym
- PALLET
- Status last verified
- Mar 2026
- First submitted
- 29 Mar 2021
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Collected Participant info that may be collected and shared :Personal and health information, Past/present medical records, Records from study visits/phone calls. Behavioral or mental health info about the participants will be collected and may be shared.The study staff, employees, and Medical Staff of Lurie Children's may use participant's info for this study and share it with study sponsor, POSNA and those working with the sponsor, IRB, Participant's other providers and their staff directly involved in their care, if their provider is a part of the Lurie Children's electronic health information exchange: The Office of Human Research Protections (OHRP), the Food and Drug Administration (FDA), or other government offices. We cannot guarantee that those listed above will not share it with others without participant's permission. Participant's names will not be included in any written or verbal reports of study results.
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Pediatric ALL Evaluation and Trial: A Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT04825587
- Acronym / sponsor ID
- PALLET / 2020-3610
- Conditions
- ACL Injury, ACL Tear
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of ChicagoUniversity, hospital or other
- Collaborators
- Children's Hospital of Philadelphia, Baylor College of Medicine, UCSF Benioff Children's Hospital - San Francisco
- Study start
- 28 Apr 2021 (actual)
- Primary completion
- 1 Apr 2030 (estimated)
- Study completion
- 1 Apr 2030 (estimated)
- First posted
- 1 Apr 2021 (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 overall aim of this multicenter RCT is to determine whether concomitant ALL reconstruction in children undergoing and ACL reconstruction will longitudinally result in a lower rate of graft failure than ACL reconstruction alone.
Detailed description
Studies have reported a rising incidence of anterior cruciate ligament (ACL) injuries in children and adolescents. Beck et al reported a 2.3% annual increase between 1994 and 2013. In New York State, the rate of pediatric ACL reconstruction climbed from 17.6/100,000 in 1990 to 50.9/100,000 by 2009. Other reports echo these findings. After ACL reconstruction, children are known to be at a higher risk for complications than adults. For example, while the rate of postoperative graft failure in adults was 3% to 4% in large national registries, as many as 12% to 19% of pediatric patients may sustain graft rupture. This can have substantial medical, financial, and psychosocial implications on the patient and family. Additionally, the results of revision ACL reconstruction are, on average, worse than after index surgery. Exploration of treatments that may lower the rate of re-injury is paramount in this population that is at highest risk.
In the adult population, a growing number of studies have suggested that concomitant reconstruction of the anterolateral ligament (ALL) with the ACL may help lower this risk. The ALL was likely first characterized in 1879 by the French surgeon Segond, who commented on the presence of a "pearly, resistant, fibrous band" in the lateral aspect of the knee. However, only in 2012 was the structure given the name "anterolateral ligament" after it was consistently identified in cadaveric specimens. Some studies suggest that the ALL is damaged during anterior cruciate ligament (ACL) injury, implying that it may supplement the ACL in providing rotational and translational stability. Biomechanical studies have confirmed that it likely plays a role in rotational stability.
A number of ALL reconstruction techniques have been developed with the hope of lowering the rate of re-injury after ACL reconstruction. Early literature in the adult population suggests that this may indeed be the case. Early case series suggested that concomitant ALL reconstruction resulted in high rates of return to sport and a low ACL graft failure rate (2.6%). Comparative retrospective studies in adults suggest better patient reported outcome scores, meniscal repair healing, and rates of return to sports when the ALL is reconstructed with the ACL compared to isolated ACL reconstruction. Finally, a prospective cohort study of adults reported that hamstring autograft ACL reconstruction with concomitant ALL reconstruction resulted in 3.1 times lower odds of graft failure than isolated hamstring ACL reconstruction and 2.5 times lower odds of failure than isolated patellar tendon ACL reconstruction.
The hypotheses to be tested in this study have never been evaluated in the pediatric population. Furthermore, the proposed investigation is a randomized controlled trial, which will allow it to provide novel results with high-level evidence. The results of such a study have the potential to change practice in a meaningful, tangible way and affect the outcomes of thousands of children annually. In addition to the medical and functional impact, there could also be important financial and psychosocial implications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The overall aim of this multicenter RCT is to determine whether concomitant ALL reconstruction in children undergoing and ACL reconstruction will result in a lower rate of graft failure than ACL reconstruction alone.
| Arm | Type | Receives |
|---|---|---|
| Concomitant ACL and ALL reconstruction | Experimental | Procedure: Patients will be randomized into one of two study arms: (1) concomitant ACL and ALL reconstruction or (2) ACL reconstruction alone.The participant will undergo both the ACL and ALL reconstruction surgery. |
| ACL reconstruction alone | Experimental | Procedure: Patients will be randomized into one of two study arms: (1) concomitant ACL and ALL reconstruction or (2) ACL reconstruction alone.The participant will undergo only ACL reconstruction surgery. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Age 18 and under
- Surgery within 6 months of injury
- Undergoing primary ACL reconstruction without previous injury or surgery
- Quadriceps tendon autograft ACL reconstruction
- Closing or closed physes
Key exclusion criteria (9 listed)
- Over 18 years old
- Previous ipsilateral knee injury or surgery
- Neuromuscular or developmental disorders affecting knee anatomy, cognition, or neuromuscular control
- Other concomitant ligament reconstruction aside from the ALL (i.e., MCL, PCL, PLC)
- Revision ACL reconstruction
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 |
|---|---|---|
| Patients will be randomized into one of two study arms: (1) concomitant ACL and ALL reconstruction or (2) ACL reconstruction alone.By randomizing patients into one of two study arms: (1) concomitant ACL and ALL reconstruction or (2) ACL reconstruction alone, following statistical analysis, we hope to determine whether concomitant ALL reconstruction in children undergoing and ACL reconstruction will longitudinally result in a lower rate of graft failure than ACL reconstruction alone. | Procedure or surgery | ACL reconstruction alone, Concomitant ACL and ALL reconstruction |
Primary outcome
Graft failure
Time frame: Complete when all 780 participants have been recruited, received an intervention and have been followed for data collection for up to 5 years.
To determine whether concomitant ALL reconstruction in children undergoing and ACL reconstruction will longitudinally result in a lower rate of graft failure (confirmed graft re-tear or asymmetric, increased pivot shift) than ACL reconstruction alone.
2 secondary outcomes
Complications of ALL reconstruction
Time frame: Complete when all 780 participants have been recruited, received an intervention and have been followed for data collection for up to 5 years.
Patient reported outcome measures
Time frame: Complete when all 780 participants have been recruited, received an intervention and have been followed for data collection for up to 5 years.
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 29 May 2026.
- Individual participant dataSharing planned: Yes. Collected Participant info that may be collected and shared :Personal and health information, Past/present medical records, Records from study visits/phone calls. Behavioral or mental health info about the participants will be collected and may be shared.The study staff, employees, and Medical Staff of Lurie Children's may use participant's info for this study and share it with study sponsor, POSNA and those working with the sponsor, IRB, Participant's other providers and their staff directly involved in their care, if their provider is a part of the Lurie Children's electronic health information exchange: The Office of Human Research Protections (OHRP), the Food and Drug Administration (FDA), or other government offices. We cannot guarantee that those listed above will not share it with others without participant's permission. Participant's names will not be included in any written or verbal reports of study results.
Related trials for ACL Injury
Not yet recruitingPhase 3
Extended Post-Operative Oral Tranexamic Acid Dosing After ACL Reconstruction
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
RecruitingObservational study
BioBrace® Augmentation in Anterior Cruciate Ligament Reconstruction Procedures
ACL Tears
RecruitingPhase 2
Preventing Injured Knees From osteoArthritis: Severity Outcomes
Osteoarthritis, Knee, Post-traumatic Osteoarthritis
Not yet recruiting
Supporting Athletes' Return to Sports After ACL Reconstruction: A Study of a Psychological Readiness Program
Anterior Cruciate Ligament Reconstruction, Anterior Cruciate Ligament Injuries
RecruitingObservational study
Evaluation of the Correlation Between Bone Tunnel Projection Placement and Clinical Outcomes in Anterior Cruciate Ligament Reconstruction Surgery
Anterior Cruciate Ligament Injury, Tunneling Technique
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.
Neeraj Patel, MD principal investigator
Ann & Robert H Lurie Children's Hospital of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patients will be randomized into one of two study arms: (1) concomitant ACL and ALL reconstruction or (2) ACL reconstruction alone. in people with ACL Injury and ACL Tear, run by Ann & Robert H Lurie Children's Hospital of Chicago 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 5 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 29 May 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 Amanda Kass (312-227-1267, akass@luriechildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Graft failure (time frame: Complete when all 780 participants have been recruited, received an intervention and have been followed for data collection for up to 5 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 May 2026.