Pediatric Orthopedic Surgery & Sports Medicine Research

Knee Injury Prevention Program (KIPP) for High School Girls

Principal Investigator: LaBella, Cynthia R., MD

Female athletes are 4-6 times more likely to tear their ACL than male athletes participating in the same sports. Research has demonstrated that there are neuromuscular differences between males and females that explain this disparity in ACL injury rates. This study is being done to determine whether a specially designed exercise program (KIPP) can lower a female teenager’s chances of having a knee injury or knee pain while playing sports. The study is also being done to see if the exercise program can improve a teenager’s fitness or athletic performance.

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Registry of Prospective ACL Reconstruction Outcomes in Young Patients

Principle Investigator: Neeraj Patel, MD

Anterior cruciate ligament (ACL) rupture is an increasingly common diagnosis in the pediatric and adolescent population due to an increased participation in sports and improved physician awareness and ability to diagnose. Historically, non-operative management with physical therapy, bracing, and activity modification was used to manage ACL rupture in very young patients to allow time for growth before surgery. More recently, improved ACL reconstruction techniques and technology have made ACL reconstruction with autograft the gold standard for treating ACL rupture in young patients. The purpose of this study is to investigate the outcomes of autograft in adolescent patients by creating a database of prospectively identified patients who undergo ACL repair or ACL reconstruction. This research study will help us better understand graft survival rate, complication rates, and other factors associated with patient outcomes. 

The Pediatric ALL Evaluation and Trial (PALLET): A Randomized, Controlled Trial

Principle Investigator: Neeraj Patel, MD

PALLET is a multicenter clinical trial that investigates whether adding anterolateral ligament (ALL) reconstruction to ACL reconstruction (ACLR) will result in a lower rate of graft failure than isolated ACLR in adolescent patients. Participants will be randomized to undergo either (a) isolated ACL reconstruction or (b) ACL and ALL reconstruction, and followed for at least 5 years. The goal of this study is to determine whether concomitant ALL reconstruction affects the risk of ACL graft failure or patient reported outcomes.

Electronic Cigarette Vaping Impact on Bone Metabolism:

Principle Investigator: Romie F. Gibly, MD

Electronic Cigarette (ECig) vaping has become epidemic in youth populations, but research on its effects is in its infancy. Although most agree ECigs are less toxic than traditional cigarette smoking, the risks of vaping are not well understood, and robust scientific research in the field has only recently begun. Through vaping, nicotine and numerous other potentially toxic products are inhaled. There is growing evidence that these products produce adverse effects on a huge variety of organ systems. However, barely any research has been published on the effects of vaping on the musculoskeletal system. Our research aims to explore the impact of electronic cigarette (ECig) vaping on the developing child’s musculoskeletal system, bone healing, and bone metabolism.

Fractures in Childhood and Adolescence: a Risk Factor for Decreased Peak Bone Mass?

Principle Investigator: Joseph Janicki, MD

This study will examine whether fractures during childhood are related to low bone mass, or bone strength, and if children with a lower bone mass are at risk for lower peak bone mass. Bones are strongest, or reach peak bone strength, between the ages of 16 and 25 years. People with weaker bones have a higher risk of fractures. This becomes clearest during later adulthood when people develop a thinning and weakening of bones called osteoporosis. After people reach peak bone strength, their bones get weaker over time. New research is showing that children who do not achieve normal peak bone strength may be at risk for fractures at a younger adult age. If we identify children with lower bone mass or strength now, we may be able to improve their bone strength during adulthood and decrease their fracture risk.

Vitamin D & Fracture Risk in the Pediatric Population

Principle Investigator: Joseph Janicki, MD

This study compares vitamin D levels in patients with a metaphyseal fracture (broken bone in the area of the bone’s growth plate) to patients with a non-metaphyseal fracture (broken bone in the non-growth plate area) by collecting blood samples from all study participants to measure vitamin D, calcium and parathyroid hormone (PTH) levels. This study will help researchers determine if there is a correlation (connection) between low vitamin D and broken bone location.

Efficacy of a Peri-Operative Surgical-Site, Multimodal Drug Injection in Pediatric Patients with Cerebral Palsy Undergoing Hip Surgery: A Randomized Controlled Trial

Principal Investigator: Vineeta Swaroop, MD

The goal of this prospective study is to assess the efficacy of pre-operative surgical site drug injection in pediatric patients with cerebral palsy undergoing hip surgery. Patients will be randomly assigned to the 2 treatment groups: surgical-site injection with ropivacaine, ketorolac, and epinephrine, or surgical-site injection with normal saline. The primary outcome measure will be total narcotic consumption in the first 48 hours after surgery. Pain scores during inpatient hospitalization following the surgical procedure, total narcotic consumption following hospital discharge, length of stay, parent satisfaction scores, and complications will also be analyzed.

How Mild is it? A Multicenter Retrospective Analysis of Outcomes and Recurrence for Clubfeet Treated by Ponseti Technique without Achilles Tenotomy

Principle Investigator: Romie F. Gibly, MD

Ponseti cast correction followed by Achilles tenotomy is the international gold standard for modern clubfoot treatment, but some patients achieve correction without tenotomy, and differences in their prognosis are not understood despite their different response to cast treatment. Without understanding if this patient population is inherently different, it is difficult to provide families with clear guidance on their potential for recurrence and the need for long term brace treatment. To address this gap in knowledge, we are performing a multicenter retrospective study of idiopathic clubfeet that did not require tenotomy to achieve full correction. Since a minority of clubfeet are correctable without tenotomy, this study will leverage multiple sites to generate a cohort sufficient to characterize the population characteristics, recurrence rates, risk factors for recurrence and subsequent treatments and complications. The results of this study will elucidate the specific prognoses for these clubfeet, and potentially set the groundwork for studying alternative treatment plans if recurrence rates are found to differ from the clubfeet requiring tenotomy.

Organized Sports Participation among patients who have undergone Ponseti treatment for Idiopathic Clubfoot

Principle Investigator: Rebecca Carl, MD

Because the early treatment of Talipes Equinovarus (TEV or clubfoot) with casting and full-time bracing prevents movement of the knee and ankle joints, affected infants do not have the same early opportunities to work on gross motor developmental skills as their peers. The purpose of this study is to attain gross motor skills in children with TEV from age 6 months to 17 years and parent report of lower extremity function in children 5 years and older. Participants that are under 5 years old would undergo a brief physical therapy evaluation every 6 months and participants that are 5 years old and older would complete brief surveys every 6 months for 3 years.

Auditory processing in children recovering from a concussion: biological insights

Principal Investigators: Cynthia LaBella, MD and Nina Kraus, PhD

The purpose of this study is to learn how the brain processes sounds while recovering from a concussion. The goal of this study is to collect sound processing (how the body hears and processes sounds) and brain functioning data from children and adolescents (8-17 years old) who have had a concussion. A sub-aim of this study is to investigate the effects of concussion on rhythmic skills in children. The study includes a battery of tests to assess auditory processing, cognitive abilities, vestibular disturbances, rhythm, and disruptions to visual tracking/processing. The battery is administered at multiple time points during a patient’s recovery to attempt to characterize auditory processing in a diverse group of children diagnosed with a concussion and to accurately map stepwise improvement in auditory processing skills as children recover from their concussions. This study can identify a new domain of concussion sequelae that merits clinical consideration.

Longitudinal study of children with concussions: 3-year follow-up of cognitive and emotional function, return to sports, and risk of re-injury

Principal Investigator: LaBella, Cynthia R., MD

In recent years, concern has increased regarding the prolonged effects of concussions in children and adolescents. Prior research shows that while most youth athletes with concussion recover within 2 weeks, about one-quarter of patients exhibit signs and symptoms lasting greater than 4 weeks. Families frequently ask about the effects of concussion on neuropsychological function, school performance, and risk for subsequent injuries, especially when a patient has had prolonged recovery. This study aims to longitudinally monitor these outcomes in children and adolescents to better inform clinicians, patients, and families about the long-term effects of concussions.

Referral of subjects to Effectiveness of an mHealth psychosocial intervention (SurgeryPal) to prevent transition from acute to chronic postsurgical pain in adolescents 

Author: Diane Sheehan, APRN

SurgeryPal is a randomized controlled effectiveness trial of the SurgeryPal intervention vs. education control to improve health and functioning in youth undergoing major musculoskeletal surgery. SurgeryPal is an app/web program that teaches coping and pain management skills to reduce distress, anxiety, and pain in youth having surgery and their families. Youth will be randomized on an individual level using a factorial design to SurgeryPal or Education during 2 phases of intervention: 1) pre-operative phase (4 week duration delivered over the 4 weeks leading up to surgery), and 2) post-operative phase (4 week duration following surgery). Thus there will be 4 treatment arms. Participants will undergo 4 online survey assessments, independent of their treatment assignment: T1: Baseline (pre-randomization); T2: acute post-surgery outcomes (daily assessment of acute outcomes beginning day 1 through day 14 after hospital discharge from surgery); T3: Post-surgery follow-up (assessment of outcomes at 3-months post-surgery); T4: Final post-surgery follow-up (assessment of outcomes at 6-months post-surgery).

CORTICES Study Group

Principal Investigator: Joseph Janicki, MD

Dr. Janicki is a member of the CORTICES study group which is a collaboration of pediatric orthopedic surgeons dedicated to improving the Quality, Safety and Value in the management of emergent orthopedic conditions through education, research and development of optimal care guidelines.

Evaluation the Necessity of Operative Irrigation and Debridement: Pediatric Randomized trial of type One Open Fractures (PROOF)

Principle Investigator: Joseph Janicki, MD

ClinicalTrial.gov ID: NCT00870064

Fractures in which bone has been exposed to the outside world through an associated skin injury, known as open fractures, are frequently encountered in orthopaedics. An open fracture usually calls for a formal, operative treatment in which the bone is exposed, foreign tissue is removed and the wound is washed out. While surgery is the current standard of care for all open fractures, not all open fractures are equal in severity and therefore may not all require surgery.

The “PROOF” trial is necessary to compare operative and non-operative treatments for type one open fractures. The advantages of non-operative (emergency room only) treatment include shorter hospital stays, avoiding the risk of general anesthesia, lower costs and lack of a larger incision. Results from this clinical trial may support the hypothesis that minor open fractures in children can be safely treated non-operatively without an increased risk of infection or an increased time to healing.

Slide Alone: Fracture Prevention in Toddlers and Youth (S.A.F.E.T.Y.)

Principle Investigator: Joseph Janicki, MD

This study will examine children diagnosed with a fracture that occurred while using a playground slide in order to understand the causes of these injuries. In our orthopaedic clinics we have observed a high volume of fractures occurring on slides and have noted that many occur while the child is going down the slide with the parent. Previous studies have observed that parent supervision has decreased incidence of playground injuries but in the case of slide injuries the presence of the parent on the slide with the child may increase the risk of fracture. Results from this study may improve the understanding of fracture risks involving slides. It may help us understand whether fractures are more common when children are accompanied down the slide by an adult or when they go down the slide on their own.

Cast or Operation for Medial Epicondyle fracture Treatment in children (COMET)

Principle Investigator: Joseph Janicki, MD

Fractures of the medial epicondyle are a common pediatric injury, with an estimated annual incidence of 40-60/100,000 per year. Some doctors advise to rest the elbow in a cast or splint and allow it to heal by itself, whilst others advise surgery to fix the bone. Despite the number of these injuries, doctors are not sure whether one way of treating them is better than the other because it has never been researched. The COMET Study is a multicenter, prospective randomized trial that is being led by the Division of Orthopaedic Surgery at Ann & Robert H. Lurie Children’s Hospital of Chicago along with the Infrastructure for Musculoskeletal Pediatric Acute Care Trials (IMPACCT) consortium.

Distal Radius Interventions for Fracture Treatment (DRIFT)

Principle Investigator: Joseph Janicki, MD

Distal radius fractures (DRFs) make up 20-25% of all pediatric fractures and are the most common fractures seen in the emergency department in children in the United States. There are different ways to treat DRFS but doctors do not know which treatment is better. This research study is being done to compare two common treatments that used by orthopaedic surgeons today to see which one is more effective. Distal Radius Interventions for Fracture Treatment (DRIFT) is a multicenter, prospective randomized trial that is being led by the Division of Orthopaedic Surgery at Ann & Robert H. Lurie Children’s Hospital of Chicago along with the Infrastructure for Musculoskeletal Pediatric Acute Care Trials (IMPACCT) consortium.

Multicenter Prospective Cohort Study on Current Treatments of Legg-Calvé-Perthes Disease

Principle Investigator: Joseph Janicki, MD 

ClinicalTrials.gov ID: NCT02040714

Legg-Calvé-Perthes disease is a childhood hip disorder which is common enough to be a significant public health problem (affects 1 in 740 boys between ages 0—14), but uncommon enough to have a sufficient number of patients from a single institution to perform a definitive prospective study comparing the results of current treatments. The present study will establish a database of prospectively identified patients with Legg-Calvé-Perthes (LCP) Disease and collect information regarding their presentation, treatment, and outcomes in the course of receiving currently available treatments. This study seeks to compare the outcomes of current treatments in the management of three age groups (ages 6—8, 8—11, >11) of patients with Perthes disease at two- and five-year followup. For each age group, two to three common treatment regimens currently used by practicing pediatric orthopaedic surgeons will be compared. The intervention a patient receives is determined through physician preference. Physicians pick an intervention for each age group and treat each patient with the same intervention.

Risk Factors for Late Presentation of Developmental Hip Dislocation and Risk Factors for Failure of Pavlik Harness Use

Principle Investigator: Joseph Janicki, MD

Developmental dysplasia of the hip (DDH) consists of a spectrum of conditions where there is abnormal development of the hip joint. The American Academy of Pediatrics (AAP) recommends physical examination screening for DDH for all newborns at birth and again periodically at well baby visits every 2 months for the first 6 months of life. Despite these recommendations, dislocated hips still go undiagnosed past 6 months of age at which time treatment becomes more complex and challenging with additional operative procedures.

We recognized that children from predominantly Spanish speaking families or children on public insurance were not getting diagnosed in infancy. We will be examining patient and family factors such as primary language and insurance status to determine if there is increased risk for late presentation associated with certain social and economic groups. This study may provide support for DDH screening to be considered a public health issue similar to asthma management and lead exposure detection, improve adherence to AAP guidelines, and support education and policy initiatives to address this health disparity.

SLIP (SCFE Longitudinal International Prospective) Registry

Principal Investigator: Joseph Janicki, MD

Slipped Capital Femoral Epiphysis (or SCFE) is the most common hip problem in teenagers, and it is one of the most commonly missed diagnoses in children. The rare nature of this condition and the broad number of surgical options available has made it difficult to decide what form of treatment might be best. Treatment outcome for a patient has been linked to how severe their initial slip is, making early diagnosis and treatment important. However, there are multiple different surgical treatment options, and there are wide variations across surgeons and hospitals in the methods and reasoning behind those methods used for management of SCFE. There remains a demand for insight regarding preferable surgical treatments and ongoing care of children affected by SCFE. This research study will help us better understand SCFE and effectiveness of treatments, which we hope will lead to a better standard of treatment for future children with the condition.

Elucidating the Discoid Meniscus with Proposed New Classification System

Principal Investigator: Craig Finlayson, MD

Discoid meniscus is an abnormal meniscal variant where the meniscus is thickened and abnormally shaped. Historically, discoid meniscus has been categorized using several proposed classification systems, but that described by Watanabe et al. remains most widely accepted. There are cases however, in which type I, type II, and type III (Wrisberg type) cannot be definitively assigned. This prospective study will aim to serve as a comprehensive classification system to eliminate uncertainty in diagnosis of discoid meniscal types. Additionally, we plan to correlate discoid type to chance of re-tear, re-operation, and/or overall outcome. 

Pediatric Tibial Spine Fractures Prospective Cohort

Principle Investigator: Neeraj Patel, MD

Tibial spine fractures are rare yet significant injuries that most commonly occur in children and adolescents. Treatment for this injury is controversial among physicians because there is no consensus on optimal treatment. The aim of this study is to prospectively examine numerous aspects of tibial spine fractures, including current treatment practices and short- and long-term outcomes. Additionally, this study will investigate if there is a genetic component involved in tibial spine injuries.

Comparison of Three Treatments for Lower Extremity Apophysitis

Principal Investigator: Carl, Rebecca L., MD

ClinicalTrial.gov ID: NCT01826071

The purpose of this study is to compare three different treatments for these types of lower extremity apophysitis- Osgood-Schlatter syndrome (OSS), Sinding-Larsen and Johansson syndrome (SLJ), or Sever's disease. The investigators hypothesize that adolescents who perform a home exercise program (HEP) consisting of active elongation exercises will have decreased pain and earlier return to sports and activities as compared to those who perform a HEP that consists of static stretching exercises or those who use symptomatic treatment with ice, acetaminophen or NSAIDs and activity modification.

Less is MOIRE: (MRI for Orthopaedic Infection Rapid Evaluation)
A rapid unsedated, noncontrast MRI protocol for pediatric musculoskeletal infection diagnosis (QSVI) 

Author: Romie F. Gibly, MD

“Acute pediatric musculoskeletal infection is a frequent reason for emergency department evaluation, hospital admission and surgical intervention. Magnetic resonance imaging (MRI) has become the standard of care for identifying osteomyelitis, pyomyositis, and septic arthritis in patients with clinical and laboratory signs of infection. In collaboration with the departments of radiology and emergency medicine, we are developing a clinical algorithm, workflow and MRI sequence design to enable rapid imaging of acute musculoskeletal infection with a goal of decreasing the number of patients that require general anesthesia or contrast and dramatically increasing the speed of imaging, enabling more rapid treatment decision-making. This is a prospective study with comparison to a retrospectively reviewed cohort. The proposed study will prospectively collect 6 months of data on patients imaged by this new protocol to evaluate for clinical effectiveness (need for repeat MRI, conversion to traditional MRI or misdiagnosis), time to imaging and treatment initiation, hospital length of stay, and cost savings. We will compare these patients and variables to a retrospective cohort of pediatric patients who underwent MRI for diagnosis of acute musculoskeletal infection.”

Simple Bone Cysts in Kids (SBoCK)

Principle Investigator: Joseph Janicki, MD 

ClinicalTrials.gov ID: NCT02193841 

Simple bone cysts (SBCs) are cysts filled with fluid that occur most frequently in the long bones (arms or legs) of children. There are many ways to treat SBCs but it is unclear if one is better than another. The purpose of this research trial is to compare the effectiveness of two common treatments that are used by surgeons today

Natural History and Muskuloskeltal Burden of Spinal Muscular Atrophy

Principal Investigator: Jill Larson, MD

Many SMA patients demonstrate concomitant hip and spine deformity. Hip instability progressing to dislocation is common in patients with SMA due to the asymmetric weakness of hip gluteal muscles. Traditionally the treatment of SMA has been supportive, focusing on maximizing pulmonary and musculoskeletal function.  Recently however, the US FDA approved Nusinersin, the first disease modifying drug treatment for SMA.  This study compares hip instability in patients being administered Nusinersin to patients who have not received Nusinersin by measuring neck/shaft angle, migration index, acetabular index, Shenton’s arc, pelvic obliquity, and Cobb angle. This study will help researchers determine if there is a correlation between Nusinersin administration and improvement of hip instability.

Bracing vs Casting in the Treatment of Idiopathic Early-Onset Scoliosis

Principal Investigator: John F. Sarwark, MD

Idiopathic early onset scoliosis (IEOS) is a rare spinal deformity affecting approximately 40 of 100,000 children. Serial casting has been the most favored treatment, but casts are usually applied with the child under general anesthesia or sedation in the operating room. Although casting is effective at resolving curvature or delaying surgical intervention, it involves risks from anesthesia. Bracing does not require anesthesia, but there are few studies reporting the outcomes and effectiveness of bracing. Therefore, the purpose of this project is to establish the relative short-term effectiveness of casting and bracing in the treatment of IEOS.

The AISE (Adolescent Idiopathic Scoliosis Etiology) Project

Principal Investigator: John F. Sarwark, MD

Adolescent Idiopathic Scoliosis (AIS) is a common spinal condition, estimated to affect approximately 1.4 million individuals between the ages of 10-17 years old in the United States. Both males and females are affected by the disease but the classic case is an adolescent female during puberty, who is healthy with normal development--until the induction of scoliosis. There has been a great deal of research done on the etiology of AIS, yet the underlying cause of the disease is unknown. Some believe it to be genetic in nature and while there may be a genetic component many recent studies have shifted focus to understanding the biomechanics of the spine and how that relates to the pathomechanism of the disease. In this ongoing discussion the one idea that has consensus is that the etiology of AIS is multifactorial in nature.

The purpose of the AISE Project has been to further our knowledge of the etiology of AIS. By understanding the elements at play during scoliosis progression, we hope to determine the underlying cause and create innovative, non-invasive, patient-friendly treatment options, such as 3D model guided physical therapy or pharmacotherapy. What we knew then to what we know now about scoliosis has changed significantly, so with the AISE project we hope the more we can learn about the etiology, the better quality of life we can provide for our patients.