Pediatric ACL: Understanding Treatment Options (PLUTO)

What is PLUTO?

PLUTO stands for “Pediatric ACL: Understanding Treatment Options”. PLUTO is a multicenter prospective cohort trial, lead by Boston’s Children’s Hospital. The goals of the study are to evaluate the safety and comparative effectiveness of non-operative treatment vs operative treatments of anterior cruciate ligament (ACL) injuries in prepubescent and pubescent patients.

How are individuals selected for this study?

If an individual has a complete anterior cruciate ligament (ACL) tear and is not done growing, they are eligible for this study.

Why is this research being conducted?  

We want to learn more about the safest and most effective treatment for ACL injuries in pre and early pubescent children. There has been an increase in ACL injuries in children in the recent years and there is still a debate regarding the best treatment option. This study will allow us to compare the most commonly used surgical methods for ACL reconstructions in children. By comparing these treatments, we will be able to compare functional and health-related outcomes.

Who is conducting this research and where is it being conducted?

This study is conducted by Dr. Kevin Shea, MD, Department of Orthopaedic Surgery at Stanford Children’s Health Hospital. This is a multi-center cohort study that will be conducted at 10 hospital across the US. The research will continue through 2026 or longer.

I am interested in learning more, participating in, or have questions about this study. Who can I reach out to?

Please contact Dr. Shea’s research coordinator, Matt Rohde at rohdem@stanford.edu with any and all study questions. If you would like to read more about the PLUTO prospective study, please visit https://www.smartpatients.com/trials/NCT02772770 or https://clinicaltrials.gov/ct2/show/NCT02772770 .

Has recruitment started? Recruitment for this study is now complete.

Research In OsteoChondritis Dissecans of the Knee (ROCK) Study

What is the ROCK Group?

The Research in Osteochondritis Dissecans of the Knee (ROCK) Group is a group of physicians, athletic trainers, and various other medical professionals dedicated to studying osteochondritis dissecans (aka OCD) and to finding the optimal treatment of OCD through clinical research. The ROCK Group website (https://kneeocd.org/) states, “OCD is a condition in which the bone that supports the cartilage inside a joint undergoes softening. This softening is caused by an interruption in the blood flow to that portion of the bone. Over time, if left untreated, this can lead to damage to the overlying cartilage of the joint. Loose pieces of bone and cartilage can even break off into the joint. Long term ramifications may even include arthritis.”

What is the “OCD of the Knee Prospective Cohort” study?  

The OCD of the Knee study is a multicenter prospective cohort study aimed at determining the optimal treatment of OCD, with an emphasis on preventing the progression to osteoarthritis and minimizing variation in treatment for this condition.

How are individuals selected for this study?

Patients, both pediatric and adult, who have confirmed OCD or a focal articular cartilage defect of the knee are eligible to participate.

Why is this research being conducted?

The purpose of this study is to obtain long-term follow-up information in order to learn about how people do over time after undergoing surgical or non-surgical treatment for OCD, including the return to activities, pain, and additionally treatment or surgery.

Who is conducting this research and where is it being conducted?

This research is being conducted by ~30 sites, including both those in the US and Canada.

I am interested in learning more, participating in, or have questions about this study. Who can I reach out to?

Please contact Dr. Shea’s research coordinator,  Matt Rohde at rohdem@stanford.edu with any and all study questions. If you would like to read more about the ROCK OCD prospective study, please visit the ROCK Group website, https://kneeocd.org/patient-education/.

Has recruitment started? Yes.

Research In OsteoChondritis Dissecans of the Elbow (ROCKET) Study

What is the ROCKET Group?

The Research in Osteochondritis Dissecans of the Elbow (ROCKET) Group is a group of physicians, athletic trainers, and various other medical professionals dedicated to studying osteochondritis dissecans (aka OCD) and to finding the optimal treatment of OCD through clinical research. The ROCKET Group website (https://elbowocd.org/) states, “OCD is a condition in which the bone that supports the cartilage inside a joint undergoes softening. This softening is caused by an interruption in the blood flow to that portion of the bone. Over time, if left untreated, this can lead to damage to the overlying cartilage of the joint. Loose pieces of bone and cartilage can even break off into the joint. Long term ramifications may even include arthritis.”

This research at Stanford University is led by Dr. Charles Chan. For any questions, feel free to reach out to cchan5@stanford.edu.

What is the “OCD of the Elbow Prospective Cohort” study?

The OCD of the Elbow study is a multicenter prospective cohort study aimed at determining the optimal treatment of OCD, with an emphasis on preventing the progression to osteoarthritis and minimizing variation in treatment for this condition.

How are individuals selected for this study?

Patients, both pediatric and adult, who have confirmed OCD or a focal articular cartilage defect of the elbow are eligible to participate.

Why is this research being conducted?

The purpose of this study is to obtain long-term follow-up information in order to learn about how people do over time after undergoing surgical or non-surgical treatment for OCD, including the return to activities, pain, and additionally treatment or surgery. According to the ROCKET Group website (https://elbowocd.org/), "no one knows exactly what causes OCD, but it has been associated with acute injuries as well as long term repetitive impact to the joint (overuse injuries).  It may also be related to problems with blood supply."

I am interested in learning more, participating in, or have questions about this study. Who can I reach out to?

Please contact Dr. Shea’s research coordinator,  Matt Rohde at rohdem@stanford.edu with any and all study questions. If you would like to read more about the ROCKET OCD prospective study, please visit the ROCKET Group website, https://elbowocd.org/.

Has recruitment started? No, but recruitment will begin in 2022.

Tibial Spine Fractures (TSF) Prospective Cohort

What is the “TSF” study?  

Tibial spine fractures are rare but occur most commonly in skeletally immature children ages 8-14 years old. The management of these injuries is controversial and the short- and long-term outcomes after treatment is not well-established in the literature. This study aims to leverage the relatively high volume of tibial spine fracture patients seen at the included sites to develop a prospective cohort that will enable the examination of numerous aspects of tibial spine fractures, including current treatment approaches and short- and long-term clinical outcomes.

How are individuals selected for this study?

Any individual who meets the following criteria may be selected:

1) Males or females ages 5 to 25 years at time of initial diagnosis.

2) Diagnosed with a tibial spine fracture.

3) Diagnosis confirmed with appropriate radiographic imaging.

Why is this research being conducted?  

A recent survey of members of the Pediatric Orthopaedic Society of North America (POSNA) conducted by the PI of this study, identified significant variation in treatment decisions even among surgeons who commonly treat this injury as part of their practice. Currently there is a paucity of high-level evidence and prospective studies in the literature available to guide practitioners on the optimal treatment approach and minimize current treatment variation. This study seeks to address this research gap and ultimately enable clinicians who treat tibial spine fractures to provide more evidence-based care that results in fewer complications and improved long-term outcomes.

I am interested in learning more, participating in, or have questions about this study. Who can I reach out to?

Please contact Dr. Shea’s research coordinator,  Matt Rohde at rohdem@stanford.edu with any and all study questions.

Sports Cohort Outcomes REgistry (SCORE)

What is SCORE?

The Sports Cohort Outcomes REgistry (SCORE) is a multicenter pediatric knee arthroscopy complication quality improvement registry initiated by the Pediatric Research in Sports Medicine (PRiSM) Group (https://www.prismsports.org/).

Why is this research being conducted?

Complication registries have recently been popularized for purposes of performance and quality improvement. Although pediatric knee arthroscopy is generally a low risk surgery, the increase of arthroscopic procedures performed in the pediatric and adolescent age group has increased the need for understanding the overall, large-scale complication. SCORE focuses on gathering data from 4 main pediatric knee arthroscopic surgeries: anterior cruciate ligament (ACL) reconstruction, tibial spine fixation, meniscus repair, and discoid meniscus surgery.

Who is conducting this research and where is it being conducted?

There are ~10 institutions currently involved in this multicenter registry, lead by the Texas Scottish Rite Hospital for Children and the PRiSM Group.

Will participation in this registry affect how I am treated in the doctor’s office?

No, participation in this registry will not affect how you are treated at the clinic. Your treatment will be no different than someone not participating in the study.

Learn about our initial findings here:

Photo source: Vericel

MACI/Vericel Randomized-Controlled Trial

What is MACI?  

MACI(R) is a biologic implant composed of autologous cultured chondrocytes on porcine collagen membrane (aka an implant made from your own cells that have been grown on a collagen membrane from a pig). This implant has already been approved by the FDA (2016) for use in adults and is indicated for the repair of single or multiple symptomatic cartilage defects of the knee. It is now being investigated for use in pediatric patients (aged 20-17) with symptomatic OCD of the knee.

How are individuals selected for this study?

Patients who are between 10 and 17 and have had at least 1 symptomatic OCD or articular cartilage defect on the knee could be eligible for this study.

Why is this research being conducted?  

This research is being conducted to determine the efficacy of the use of the MACI implant in an adolescent patient. The implant has already been approved by the FDA for use in adults and as children typically heal more quickly than adults, it is reasonable that this implant work just as well, if not better, in children.

Who is conducting this research and where is it being conducted?

There are ~10 study centers involved in this multicenter study. This study is being funded by Vericel.

Will participation in this study effect how I am treated in the doctor’s office?

Yes. Participation in this study entails a randomized sorting (2:1 ratio) into either the MACI implant study group or the microfracture study group.

I am interested in learning more, participating in, or have questions about this study. Who can I reach out to?

Please contact Dr. Shea’s research coordinator, Matt Rohde at rohdem@stanford.edu with any and all study questions. If you would like to read more about the Vericel-MACI prospective study, please visit https://www.maci.com/patients/ or https://vcel.com/research-and-development/ .  

Has recruitment started? Yes.

Behaviors and Outlooks in Multi-Sport Highschool Competitive Swimmers

Principal Investigator: Dr. Charles Chan

Student Support: Shin Mei Chan, Eli Cahan

PatelloFemoral Instability in Syndromic Patients

In collaboration with Hospital for Special Surgery, we are performing a retrospective chart review studying patients with operative patellofemoral instability (PFI) and Down Syndrome. Down syndrome is one of the most common chromosomal abnormalities, and approximately 20% of patients with Down Syndrome present with patellar instability. Commonly presenting with generalized laxity, if left untreated PFI can eventually lead to pain, weakness, and deterioration of gait. Moreover, other chromosomal abnormalities such as Marfan Syndrome and other conditions such as nail-patella and Ehlers Danlos syndrome similarly present with high rates of patellar instability. Thus, the objective of this study is to determine the indications, surgical treatment, complications and outcomes, and 2nd surgery rate in this relatively small patient population to help guide potential future prospective studies. 

Cadaveric Research Lab

Each summer, the ROCK Group (https://kneeocd.org/) led by Dr. Kevin Shea conducts a pediatric cadaveric dissections’ lab at AlloSource (Centennial, CO), a tissue manufacturing and distributing company (https://www.allosource.org/about-allosource/). During the lab, orthopaedic surgeons, medical students, and premedical-students explore human anatomy and gather data vital to answering some of the field’s most pressing developmental and anatomic questions. The purpose of this lab is to gather data to learn more about pediatric knee anatomy for the improvement of safe ligament reconstruction techniques and the understanding of the development and growth patterns of pediatric knees and more.

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Recently some of the work produced by the cadaver lab received the John J. Joyce Award (First Place) at the 12th ISAKOS Biennial Congress in Cancun, Mexico on May 15, 2019.

Iseki TI, Rothrauff BB, Kihara S, Shea KG, Alexander PG, Fu FH, Musahl V. “Absence of Ligament Progenitor Cells in the Pediatric Knee Anterolateral Complex”

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If you have interest in participating in the cadaveric lab, please reach out to Matt Rohde, Clinical Research Coordinator, at rohdem@stanford.edu.

Maternal and Children’s Research Institute Grant for Meniscus Research in Pediatric Knee Cadavers

With funding from the Maternal and Children’s Health Institute, we are investigating the structure and composition of meniscus tissue in rare pediatric cadavers. Our goal is to analyze the quantitative magnetic resonance parameters, mechanical properties, and biochemical composition to define the relationship between age and the measured properties to reveal changes in structure-function relationships during the development of pediatric menisci. The findings of this study will provide a foundational understanding of meniscus structure that will help guide future clinical investigations into treatment options for pediatric meniscal injuries.

Recent Studies

Epidemiologic Study of Pediatric Discoid Menisci

Discoid menisci are one of the most common variants of pediatric menisci, yet there are only a few studies that have examined the histology. In our study, we performed histological assessment on two cadaveric knees from 4-year-old and 11-year-old donors. We found that the discoid menisci have a statically significant decrease in cellularity and increase in proteoglycan content compared to normal menisci. These histological differences offer an explanation for the biomechanical differences and the increase in pathologies related to the discoid meniscus previously reported in literature

Randhawa SS, Tran EP, Segovia NA, Ganley TJ, Tompkins M, Ellis H, Shea KG. (July 14, 2021) Epidemiologic Study of the Discoid Meniscus: Investigating Demographic-Based Predictors in Large-Scale Claims Database. Orthopaedic Journal of Sports Medicine. doi:10.1177/2325967121S00086.

Biomechanical Simulation of Radial Head Subluxation in Cadaveric Pediatric Elbows

Radial head subluxation, known as pulled elbow or Nursemaid’s elbow, is a common pediatric condition that occurs when a longitudinal traction force is applied to an elbow that is pronated and extended. The purpose of this study was to demonstrate and quantify the axial traction force required to produce a nursemaid’s elbow in pediatric cadaver specimens. Using two cadaveric elbows from a single 3-year-old male donor, specimens were dissected by a fellowship-trained orthopedic surgeon and tested on an Instron machine via axial loading. The study shows that the force to subluxate the radial through the annual ligament, and after a first subluxation requires reduced forces. This may explain why this can become a recurrent injury in some patients.  

Meadows M, Vuong B, Storaci H, Tam K, Shea K. (July 14, 2021) Biomechanical Simulation of Radial Head Subluxation in Cadaveric Pediatric Elbows. Orthopaedic Journal of Sports Medicine. doi:10.1177/2325967121S00158.

Highlighted Work of Cadaver Lab

Schmidt EC, Chin M, Aoyama JT, Ganley TJ, Shea KG, Hast MW. Mechanical and Microstructural Properties of Native Pediatric Posterior Cruciate and Collateral Ligaments. Orthopaedic journal of sports medicine. 2019 Jan 30;7(2):2325967118824400.

Schmidt EC, Chin M, Aoyama JT, Ganley TJ, Shea KG, Hast MW. Mechanical and microstructural properties of pediatric anterior cruciate ligaments and autograft tendons used for reconstruction. Orthopaedic journal of sports medicine. 2019 Jan 23;7(1):2325967118821667.

Shea KG, Milewski MD, Cannamela PC, Ganley TJ, Fabricant PD, Terhune EB, Styhl AC, Anderson AF, Polousky JD. Anterolateral ligament of the knee shows variable anatomy in pediatric specimens. Clinical Orthopaedics and Related Research. 2017 Jun 1;475(6):1583-91.

Shea KG, Cannamela PC, Fabricant PD, Terhune EB, Polousky JD, Milewski MD, Ganley TJ, Anderson AF. Lateral radiographic landmarks for ACL and LCL footprint origins during all-epiphyseal femoral drilling in skeletally immature knees. JBJS. 2017 Mar 15;99(6):506-11.

Richmond CG, Cannamela PC, Fabricant PD, Ganley TJ, Beckmann JT, Anderson AF, Shea KG. It is feasible to perform an all-epiphyseal double-bundle posterior cruciate ligament reconstruction in skeletally immature patients? A computer-aided modelling study. Journal of ISAKOS: Joint Disorders & Orthopaedic Sports Medicine. 2018 Jan 1;3(1):17-20.

Shea KG, Cannamela PC, Fabricant PD, Terhune EB, Polousky JD, Milewski MD, Anderson AF, Ganley TJ. All-epiphyseal anterior cruciate ligament femoral tunnel drilling: avoiding injury to the physis, lateral collateral ligament, anterolateral ligament, and popliteus—a 3-dimensional computed tomography study. Arthroscopy: The Journal of Arthroscopic & Related Surgery. 2018 May 1;34(5):1570-8.

Troyer S, Anchustegui NG, Richmond CG, Cannamela PC, Dingel A, Stavinoha TJ, Ganley TJ, Anderson AF, Shea KG. Avoiding tibia physeal injury during double-bundle posterior cruciate ligament reconstruction. Journal of ISAKOS: Joint Disorders & Orthopaedic Sports Medicine. 2018 Jan 1;3(1):21-5.

Olstad K, Shea KG, Cannamela PC, Polousky JD, Ekman S, Ytrehus B, Carlson CS. Juvenile osteochondritis dissecans of the knee is a result of failure of the blood supply to growth cartilage and osteochondrosis. Osteoarthritis and cartilage. 2018 Dec 1;26(12):1691-8.