Anterior Cruciate Ligament ReconstructionPLUTONCT02772770
Pediatric ACL: Understanding Treatment Options
An observational study of Anterior Cruciate Ligament Reconstruction, run by Boston Children's Hospital at 10 sites in United States.
Trial summary
Pediatric ACL: Understanding Treatment Outcomes (PLUTO) is a multi-center, prospective cohort study. Specific aims of PLUTO are to evaluate the safety and comparative effectiveness of non-operative treatment, as well as four operative treatments including (1) transphyseal ACL reconstruction (2) partial transphyseal… Read more about this study
- Who is it for?
- Ages 5 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Anterior Cruciate Ligament Reconstruction
- What is being tested?
- Non-operative treatment group will undergo standardized treatment which will include rehabilitation, bracing and certain activity restrictions, Surgical technique: Transphyseal reconstruction and Surgical technique: Partial transphyseal reconstruction
- Type of treatment
- Surgery or procedure
- How many people
- 765 participants
- Where
- 10 sitesUnited States
- Study dates
- Sep 2016to Dec 2030
- Phase
- Observational
- 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 5 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: The pool of patients for this study will be patients seen in outpatient and sports medicine clinics at each clinical center. The minimum accrual target for this study is 360 surgical patients and 45 non-operative patients
Who may be able to join
- Diagnosis of complete intrasubstance ACL tear
- Skeletally Immature (by knee radiographs)
Who cannot join
- Prior ACL surgery on the ipsilateral knee
- Congenital ACL deficiency
- Multiple ligament reconstruction required
- Other significant comorbidities including syndromic conditions, neuromuscular disorders or developmental delay
- If scheduling of the ACL surgery is impacted by the skeletal maturity of the patient
- Simultaneous bilateral ACL tears
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Children's Healthcare of Atlanta
Atlanta, Georgia, 30342
Boston Children's Hospital
Boston, Massachusetts, 02115
Cincinnati Children's Medical Center
Cincinnati, Ohio, 45229
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Tennessee Orthopaedic Alliance
Nashville, Tennessee, 37205
Hospital for Special Surgery
New York, New York, 10021
Stanford University Medical Center
Palo Alto, California, 94304
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Rady Children's Hospital
San Diego, California, 92123
Washington University at St. Louis
St Louis, Missouri, 63130
About this study
Official title: Pediatric ACL: Understanding Treatment Options (PLUTO)
Pediatric ACL: Understanding Treatment Outcomes (PLUTO) is a multi-center, prospective cohort study. Specific aims of PLUTO are to evaluate the safety and comparative effectiveness of non-operative treatment, as well as four operative treatments including (1) transphyseal ACL reconstruction (2) partial transphyseal ACL reconstruction, (3) physeal-sparing epiphyseal ACL reconstruction using the Anderson technique, and (4) physeal-sparing ACL reconstruction using the Micheli/Kocher technique in prepubescent and pubescent skeletally immature patients.
Read the detailed description
Anterior Cruciate Ligament (ACL) injuries are being seen with increased frequency in pediatric and adolescent patients. The management of these injuries is controversial and includes nonoperative treatment and operative treatment with various surgical techniques. Pediatric ACL: Understanding Treatment Outcomes (PLUTO) is a multi-center, prospective cohort study. Specific aims of PLUTO are to evaluate the safety and comparative effectiveness of non-operative treatment, as well as four operative treatments including (1) transphyseal ACL reconstruction (2) partial transphyseal ACL reconstruction, (3) physeal-sparing epiphyseal ACL reconstruction using the Anderson technique, and (4) physeal-sparing ACL reconstruction using the Micheli/Kocher technique in prepubescent and pubescent skeletally immature patients. Accrual will take place over eight years at 9 pediatric sports medicine centers. Post-treatment outcome assessment will be performed at 6-9 months, 1 year, and 2, 5, and 10 years after treatment , including functional outcome, activity level, health-related quality of life, graft survivorship, knee stability, knee motion, and growth disturbance.
- Being tested
- Non-operative treatment group will undergo standardized treatment which will include rehabilitation, bracing and certain activity restrictions, Surgical technique: Transphyseal reconstruction, Surgical technique: Partial transphyseal reconstruction, Surgical technique: Physeal sparing reconstruction by the Anderson method, Surgical technique: Physeal sparing reconstruction by the Micheli/Kocher method
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-operative treatment group will undergo standardized treatment which will include rehabilitation, bracing and certain activity restrictionsOther
The non-operative treatment group will undergo standardized treatment which will include rehabilitation, bracing and certain activity restrictions.
Surgical technique: Transphyseal reconstructionProcedure or surgery
Study physicians will have the option to treat ACL injuries operatively or non-operatively, according to their standard of care. However, once the decision is made to manage the injury operatively or non-operatively, the physician must follow the appropriate standardized treatment protocol developed for the study. The operative treatment protocol will include standardized surgical techniques for transphyseal reconstruction with soft tissue graft and metaphyseal fixation.
Surgical technique: Partial transphyseal reconstructionProcedure or surgery
Study physicians will have the option to treat ACL injuries operatively or non-operatively, according to their standard of care. However, once the decision is made to manage the injury operatively or non-operatively, the physician must follow the appropriate standardized treatment protocol developed for the study. The operative treatment protocol will include partial transphyseal reconstruction (tibial transphyseal and femoral epiphyseal) with soft tissue graft.
Surgical technique: Physeal sparing reconstruction by the Anderson methodProcedure or surgery
Study physicians will have the option to treat ACL injuries operatively or non-operatively, according to their standard of care. However, once the decision is made to manage the injury operatively or non-operatively, the physician must follow the appropriate standardized treatment protocol developed for the study. The operative treatment protocol will include standardized surgical techniques for physeal sparing epiphyseal reconstruction with soft tissue graft (Anderson technique).
Surgical technique: Physeal sparing reconstruction by the Micheli/Kocher methodProcedure or surgery
Study physicians will have the option to treat ACL injuries operatively or non-operatively, according to their standard of care. However, once the decision is made to manage the injury operatively or non-operatively, the physician must follow the appropriate standardized treatment protocol developed for the study. The operative treatment protocol will include physeal-sparing with Iliotibial band combined extra-articular and intra-articular reconstructions (Micheli/Kocher Technique).
| Study group | Role | What they receive |
|---|---|---|
| Non Operative: Rehabilitation, Bracing, Activity Restriction | Not described Receives: Other: Non-operative treatment group will undergo standardized treatment which will include rehabilitation, bracing and certain activity restrictions | |
| Operative: Transphyseal | Not described Receives: Procedure: Surgical technique: Transphyseal reconstruction | |
| Operative: Partial Transphyseal | Not described Receives: Procedure: Surgical technique: Partial transphyseal reconstruction | |
| Operative: Physeal sparing by Anderson Technique | Not described Receives: Procedure: Surgical technique: Physeal sparing reconstruction by the Anderson method | |
| Operative: Physeal sparing by Micheli/Kocher Technique | Not described Receives: Procedure: Surgical technique: Physeal sparing reconstruction by the Micheli/Kocher method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee functional outcome at 2 years post-ACL reconstruction (Pedi-IKDC)
To compare outcomes associated with four surgical techniques performed to treat complete intrasubstance ACL tears in pre- and early pubescent children: (1) transphyseal ACL reconstruction (2) partial transphyseal ACL reconstruction, (3) physeal-sparing epiphyseal ACL reconstruction using the Anderson technique, and (4) physeal-sparing ACL reconstruction using the Micheli/Kocher technique.
Measured: 2 years
Secondary outcomes (4)
Health-related quality of life (Pediatric Quality of Life Inventory (PedsQL)
To compare outcomes associated with four surgical techniques performed to treat complete intrasubstance ACL tears in pre- and early pubescent children: (1) transphyseal ACL reconstruction (2) partial transphyseal ACL reconstruction, (3) physeal-sparing epiphyseal ACL reconstruction using the Anderson technique, and (4) physeal-sparing ACL reconstruction using the Micheli/Kocher technique.
Measured: 2 years
Graft failure (MRI, Lachman, Pivot-Shift)
To compare outcomes associated with four surgical techniques performed to treat complete intrasubstance ACL tears in pre- and early pubescent children: (1) transphyseal ACL reconstruction (2) partial transphyseal ACL reconstruction, (3) physeal-sparing epiphyseal ACL reconstruction using the Anderson technique, and (4) physeal-sparing ACL reconstruction using the Micheli/Kocher technique.
Measured: 2 years
Activity level (P-FABS and Physical Activity Questionnaire)
To compare outcomes associated with four surgical techniques performed to treat complete intrasubstance ACL tears in pre- and early pubescent children: (1) transphyseal ACL reconstruction (2) partial transphyseal ACL reconstruction, (3) physeal-sparing epiphyseal ACL reconstruction using the Anderson technique, and (4) physeal-sparing ACL reconstruction using the Micheli/Kocher technique.
Measured: 2 years
Growth disturbance (angular deformity, leg length discrepancy per clinical exam and radiographs)
To compare outcomes associated with four surgical techniques performed to treat complete intrasubstance ACL tears in pre- and early pubescent children: (1) transphyseal ACL reconstruction (2) partial transphyseal ACL reconstruction, (3) physeal-sparing epiphyseal ACL reconstruction using the Anderson technique, and (4) physeal-sparing ACL reconstruction using the Micheli/Kocher technique.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2016 (estimated)
- Study startSep 2016
- Primary completionMay 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament ReconstructionStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 765 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital of Philadelphia, Children's Hospital Medical Center, Cincinnati, Rady Children's Hospital, San Diego, Washington University School of Medicine, Children's Healthcare of Atlanta, The Cleveland Clinic, Tennessee Orthopedic Alliance, Hospital for Special Surgery, New York, Stanford University
- Responsible party
- Principal investigator, Mininder Kocher, Boston Children's Hospital
- Investigators
- Mininder S Kocher, MD, MPH, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02772770
- Sponsor's protocol ID
- IRB-P00017850
- Acronym
- PLUTO
- Status last verified
- May 2025
- First submitted
- 11 May 2016
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric ACL: Understanding Treatment Options (PLUTO)
- ClinicalTrials.gov ID
- NCT02772770
- Acronym / sponsor ID
- PLUTO / IRB-P00017850
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 765 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- Children's Hospital of Philadelphia, Children's Hospital Medical Center, Cincinnati, Rady Children's Hospital, San Diego, Washington University School of Medicine, Children's Healthcare of Atlanta, The Cleveland Clinic, Tennessee Orthopedic Alliance, Hospital for Special Surgery, New York, Stanford University
- Study start
- Sep 2016 (actual)
- Primary completion
- May 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 16 May 2016 (estimated)
- 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.
Pediatric ACL: Understanding Treatment Outcomes (PLUTO) is a multi-center, prospective cohort study. Specific aims of PLUTO are to evaluate the safety and comparative effectiveness of non-operative treatment, as well as four operative treatments including (1) transphyseal ACL reconstruction (2) partial transphyseal ACL reconstruction, (3) physeal-sparing epiphyseal ACL reconstruction using the Anderson technique, and (4) physeal-sparing ACL reconstruction using the Micheli/Kocher technique in prepubescent and pubescent skeletally immature patients.
Detailed description
Anterior Cruciate Ligament (ACL) injuries are being seen with increased frequency in pediatric and adolescent patients. The management of these injuries is controversial and includes nonoperative treatment and operative treatment with various surgical techniques. Pediatric ACL: Understanding Treatment Outcomes (PLUTO) is a multi-center, prospective cohort study. Specific aims of PLUTO are to evaluate the safety and comparative effectiveness of non-operative treatment, as well as four operative treatments including (1) transphyseal ACL reconstruction (2) partial transphyseal ACL reconstruction, (3) physeal-sparing epiphyseal ACL reconstruction using the Anderson technique, and (4) physeal-sparing ACL reconstruction using the Micheli/Kocher technique in prepubescent and pubescent skeletally immature patients. Accrual will take place over eight years at 9 pediatric sports medicine centers. Post-treatment outcome assessment will be performed at 6-9 months, 1 year, and 2, 5, and 10 years after treatment , including functional outcome, activity level, health-related quality of life, graft survivorship, knee stability, knee motion, and growth disturbance.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Non Operative: Rehabilitation, Bracing, Activity Restriction | – | Other: Non-operative treatment group will undergo standardized treatment which will include rehabilitation, bracing and certain activity restrictions |
| Operative: Transphyseal | – | Procedure: Surgical technique: Transphyseal reconstruction |
| Operative: Partial Transphyseal | – | Procedure: Surgical technique: Partial transphyseal reconstruction |
| Operative: Physeal sparing by Anderson Technique | – | Procedure: Surgical technique: Physeal sparing reconstruction by the Anderson method |
| Operative: Physeal sparing by Micheli/Kocher Technique | – | Procedure: Surgical technique: Physeal sparing reconstruction by the Micheli/Kocher method |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- The pool of patients for this study will be patients seen in outpatient and sports medicine clinics at each clinical center. The minimum accrual target for this study is 360 surgical patients and 45 non-operative patients
Key inclusion criteria (2 listed)
- Diagnosis of complete intrasubstance ACL tear
- Skeletally Immature (by knee radiographs)
Key exclusion criteria (6 listed)
- Prior ACL surgery on the ipsilateral knee
- Congenital ACL deficiency
- Multiple ligament reconstruction required
- Other significant comorbidities including syndromic conditions, neuromuscular disorders or developmental delay
- If scheduling of the ACL surgery is impacted by the skeletal maturity of the patient
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 |
|---|---|---|
| Non-operative treatment group will undergo standardized treatment which will include rehabilitation, bracing and certain activity restrictionsThe non-operative treatment group will undergo standardized treatment which will include rehabilitation, bracing and certain activity restrictions. | Other | Non Operative: Rehabilitation, Bracing, Activity Restriction |
| Surgical technique: Transphyseal reconstructionStudy physicians will have the option to treat ACL injuries operatively or non-operatively, according to their standard of care. However, once the decision is made to manage the injury operatively or non-operatively, the physician must follow the appropriate standardized treatment protocol developed for the study. The operative treatment protocol will include standardized surgical techniques for transphyseal reconstruction with soft tissue graft and metaphyseal fixation. | Procedure or surgery | Operative: Transphyseal |
| Surgical technique: Partial transphyseal reconstructionStudy physicians will have the option to treat ACL injuries operatively or non-operatively, according to their standard of care. However, once the decision is made to manage the injury operatively or non-operatively, the physician must follow the appropriate standardized treatment protocol developed for the study. The operative treatment protocol will include partial transphyseal reconstruction (tibial transphyseal and femoral epiphyseal) with soft tissue graft. | Procedure or surgery | Operative: Partial Transphyseal |
| Surgical technique: Physeal sparing reconstruction by the Anderson methodStudy physicians will have the option to treat ACL injuries operatively or non-operatively, according to their standard of care. However, once the decision is made to manage the injury operatively or non-operatively, the physician must follow the appropriate standardized treatment protocol developed for the study. The operative treatment protocol will include standardized surgical techniques for physeal sparing epiphyseal reconstruction with soft tissue graft (Anderson technique). | Procedure or surgery | Operative: Physeal sparing by Anderson Technique |
| Surgical technique: Physeal sparing reconstruction by the Micheli/Kocher methodStudy physicians will have the option to treat ACL injuries operatively or non-operatively, according to their standard of care. However, once the decision is made to manage the injury operatively or non-operatively, the physician must follow the appropriate standardized treatment protocol developed for the study. The operative treatment protocol will include physeal-sparing with Iliotibial band combined extra-articular and intra-articular reconstructions (Micheli/Kocher Technique). | Procedure or surgery | Operative: Physeal sparing by Micheli/Kocher Technique |
Primary outcome
Knee functional outcome at 2 years post-ACL reconstruction (Pedi-IKDC)
Time frame: 2 years
To compare outcomes associated with four surgical techniques performed to treat complete intrasubstance ACL tears in pre- and early pubescent children: (1) transphyseal ACL reconstruction (2) partial transphyseal ACL reconstruction, (3) physeal-sparing epiphyseal ACL reconstruction using the Anderson technique, and (4) physeal-sparing ACL reconstruction using the Micheli/Kocher technique.
4 secondary outcomes
Health-related quality of life (Pediatric Quality of Life Inventory (PedsQL)
Time frame: 2 years
Graft failure (MRI, Lachman, Pivot-Shift)
Time frame: 2 years
Activity level (P-FABS and Physical Activity Questionnaire)
Time frame: 2 years
Growth disturbance (angular deformity, leg length discrepancy per clinical exam and radiographs)
Time frame: 2 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 13 May 2025.
- Individual participant dataSharing planned: No
Related trials for Anterior Cruciate Ligament Reconstruction
Not yet recruiting
Dry Needling and Quad Strength After Anterior Cruciate Ligament Reconstruction
Anterior Cruciate Ligament Reconstruction Rehabilitation, Dry Needling
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
Recruiting
The Effect of Isokinetic Vs Plyometric Training in Post-ACLR Surgery
Anterior Cruciate Ligament Reconstruction (ACLR), Anterior Cruciate Ligament Reconstruction Rehabilitation
Recruiting
The Effect of Plyometric Training in Post-ACLR Surgery
Anterior Cruciate Ligament Reconstruction (ACLR), Anterior Cruciate Ligament Reconstruction Rehabilitation
RecruitingPhase 4
Anterior Femoral and Adductor Canal Nerve Blocks in Peds Knees
Anterior Cruciate Ligament Reconstruction, Medial Patellofemoral Ligament Reconstruction
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. This study is not recruiting at the moment.
Mininder S Kocher, MD, MPH principal investigator
Boston Children's Hospital
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anterior Cruciate Ligament Reconstruction, run by Boston Children's Hospital at 10 sites 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 2 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee functional outcome at 2 years post-ACL reconstruction (Pedi-IKDC) (time frame: 2 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 13 May 2025; AzTrials last refreshed its copy on 30 Oct 2026.