Pediatric Orthopedic Surgery Research

The Division of Orthopaedic Surgery and Sports Medicine is engaged in many research studies to improve the bone health of children, prevent injuries and the need for unnecessary surgeries, and address health disparities in children's orthopaedic care. 


Clinical Studies

“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.

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“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.

"Timing of Pavlik Harness: Can We Wait?"

Principal Investigator: Joseph Janicki, MD

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

Principle Investigator: Joseph Janicki, MD 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.

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“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.

"A Study of INFUSE Bone Graft (recombinant human Bone Morphogenetic Protein-2/absorbable collagen sponge) in the treatment of Tibial Pseudarthrosis in Neurofibromatosis 1 (NF1)"

Principle Investigator: Robert Listernick, MD

Tibial pseudarthrosis in patients with neurofibromatosis type 1 (NF1) is a serious problem of the lower leg. Tibial pseudarthrosis is seen in about 3% of people with NF1 and it occurs when abnormal bone of the tibia (lower leg bone) develops a fracture (break) that does not heal. The purpose of this study is to evaluate the use of Infuse Bone Graft (a product containing bone morphogenetic proteins (BMPs), which are naturally occurring substances that are involved in bone formation) to treat tibial pseudarthrosis in patients with NF1 to determine if it works and whether or not it is safe for this use. Information learned from this study may help future patients with NF1 and tibial pseudarthrosis. The potential benefit of the treatment with Infuse Bone Graft is that it may improve the healing of the tibia. It may lessen the risk for future fracture of the tibia, and thus lessen the need for future surgeries, including the need for amputation.

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

Principle Investigator: Joseph Janicki, MD 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.

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"Simple Bone Cysts in Kids (SBoCK)"

Principle Investigator: Joseph Janicki, MD 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

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"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.

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.

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.

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.