The Harms Study Group is extremely grateful to our industry partners for their ongoing support of our research. This section highlights our active multi-center research studies that are currently funded.
Special thanks to our supporters:
Scoliosis Outcomes Database Registry
The purpose of this study is to analyze the outcomes of surgical treatment of idiopathic scoliosis of all curve patterns treated by either anterior or posterior procedures.
The patients enrolled in this multi-center prospective registry are between the ages of 10 and 21 years and have the diagnosis of idiopathic scoliosis for which surgery has been recommended to prevent progression of their curvature. There are currently over 5,500 patients enrolled from 14 participating research sites.
The potential patient population the results of this study will help are patients with idiopathic scoliosis, during both adolescence and into adulthood.
The global impact of this study is profound as this is the largest prospective database for Idiopathic Scoliosis. Over 45 abstracts are presented and over 15 peer-reviewed publications are produced on annual basis.
The annual funding needed to carry out this research effort is >$1,000,000.
Prospective Database Registry Study of Scoliosis in Children with Cerebral Palsy
The purpose of this study is to analyze the outcomes of surgical treatment and non-operative treatment of Children with Cerebral Palsy. The patients enrolled in this multi-center prospective registry are between the ages of 8 and 21 years and have the diagnosis of Cerebral Palsy with total body involvement and of any functional level. Their coronal curve must be >50 degrees or their kyphotic curve must be > 70 degrees. A cohort of spinal fusion patients and a cohort of non-operative patients are being followed.
There are currently over 500 operative patients and over 150 non-operative patients enrolled from 12 participating research sites.
The potential patient population the results of this study will help are patients with Cerebral Palsy and Scoliosis as well as Scoliosis patients with other neuromuscular diseases.
The global impact of this study is significant as it is producing answers to important clinical questions in this medically fragile patient population.
The annual funding needed to carry out this research effort is >$350,000.
Return to Function following Fusion of the Spine in Adolescent Idiopathic Scoliosis
The aim of this pilot study is to assess the timing of return to baseline function in patients in the early post-operative period following spinal deformity correction and fusion for adolescent idiopathic scoliosis (AIS).
The patients enrolled in this multi-center prospective pilot study are patients with the diagnosis of Adolescent Idiopathic Scoliosis and are undergoing surgical correction of their spinal deformity with a posterior spinal fusion. Patients enrolled in this study are co-enrolled in the Scoliosis Outcomes
The potential patient population the results of this study will help are patients with idiopathic scoliosis. The information gained will assist surgeons and clinicians caring for these patients.
The global impact of this study is the identification of the factors which delay a return to baseline function may help patients better prepare for their surgery.
The annual funding needed to carry out this research effort is >$40,000.
The Long-Term Follow Up of Operative Outcomes in Patients with Idiopathic Scoliosis
Currently, there is limited funding for the data collection efforts associated with the longer term follow-up visits (10, 15 and 20 years) of post-operative patients with Adolescent Idiopathic Scoliosis. The aim of this research effort is to determine the long term surgical outcomes of patients with AIS. Longer term (>10 years) follow-up data is sparse in surgically treated patients with AIS. To our knowledge, there are no published series that prospectively compare changes in curve correction, Health Related Quality of Life (HRQOL) scores and major complications in AIS patients from the early and midterm (5 year post-op) follow-up to the longer term (10 years or greater post-op) follow-up. Understanding which patients are at risk of a less than ideal outcome is the critical knowledge waiting to be understood from this valuable long term follow-up data, along with so many other important clinical questions that can be answered.
The annual funding needed to carry out this research effort is $100,000.
Current Un-funded Studies
Development of a Shared Decision Making Tool for AIS
The shared-decision model (SDM) blends the traditional model of care, with the physician making decision, with the informed-decision making model. This model allows physicians to educate the patient, while patients express their preferences and treatment goals. Decision-making aids allow for improved communication between patients and caregivers. When patients are engaged in their care, confidence, satisfaction, and adherence to treatment increase. Our long-term goal is to improve patient-reported outcomes for moderate, skeletally mature AIS patients through a SDM model. The objective here, which is the first step in this goal, is to develop a decision-making aid to improve communication between patients, parents, and caregivers. This effort currently is not funded.
Without thorough information on the natural history of AIS, treatment decisions are restricted. The knowledge of outcomes of non-surgically treated patients has been based on literature with many shortcomings. In order to advance the care of AIS patients, study of non-operative patients must be held to the same standards as operative outcomes: prospective and longitudinal. Through this research effort to collect Non-operative, prospective Idiopathic Scoliosis Patient data, we can begin to understand the implications of operative treatment and how outcomes compare to non-operative patients. These findings will enhance understanding of AIS surgical indications by providing the necessary control group for operative studies. This important research initiative is currently unfunded.
PROMIS in AIS
Patient reported outcomes of treatment are crucial in advancing treatment and improvement in the ability to assess these outcomes is essential. This research effort will allow our research group to advance our efforts in directing research towards treatment solutions to improve quality of life in scoliosis patients. The Patient-Reported Outcomes Measurement Information System (PROMIS) is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. It utilizes computer-adaptive testing to implement item-response theory based hierarchy of domain question items. It is not disease specific. This research effort will access the utility, sensitivity and reliability of the PROMIS Domains for the ability to detect change after surgery for patients with AIS. It will also compare the current Health Related Quality of Life Tool used in our Idiopathic Scoliosis Outcomes registry: the SRS questionnaire (version 22r) and PROMIS instrument performance.
The Long-Term Follow-up of Outcomes in Patients with Cerebral Palsy & Scoliosis
Cerebral palsy (CP) affects 2 per 1000 births. More than 60% of children with total-body CP will develop a progressive spinal deformity. Surgical treatment of CP-related scoliosis remains controversial with few clearly defined indications, high complication rates, unclear benefits to the patient and/or caregiver, and high societal costs. There are many gaps in knowledge in the understanding of the outcomes of operative and non-operative treatment in patients with CP-related scoliosis, especially related to the long-term outcomes of these patients. Currently, there is limited funding for the data collection efforts associated with longer term follow-up visits (5 and 10 years) of operative and non-operative patients with Cerebral Palsy and Scoliosis.
AIS Blood Loss Best Practice Guidelines – Development & Distribution
Average Blood Loss for patients undergoing PSF for AIS are often reported at more the 1000 ml. Minimizing blood loss has obvious benefits in minimizing transfusion related risks, but is also important in protecting the valuable allogeneic blood bank resources. We believe we can provide surgeons a risk adjusted average blood loss that will allow them to compare themselves to their peers as a mechanism of self-assessment and improvement. Minimizing the physiologic effects of blood loss are known to have other positive effects on a patient’s post-operative course such as improved mobility, gastrointestinal function and strength, as well as reduced risk of infection. Developing a risk adjusted BL performance measure has the potential to significantly improve surgeon performance with reduced postoperative BL. We currently do not have funding for this effort.
CP Scoliosis Best Practice Guidelines – Development & Distribution
Our initial review of the use of dashboard reporting within the HSG surgeon membership for AIS surgical patient data has resulted in over 60% of surgeons improving their operative times and decreasing surgical Blood Loss in just one year! This dashboard reporting format enabled comparative analysis of individual’s surgeon’s outcomes and variability of practices which has aided in the development of a Best Practice Guideline for postoperative treatment in AIS. We would like to implement this practice with our CP Scoliosis patient data and begin to develop Best Practice Guidelines to improve care in this medically fragile patient population. We currently do not have funding for this quality and safety initiative.
The purpose of this research effort is to assess inter-vertebral coronal motion of the unfused distal segments of the spine in patients with adolescent idiopathic scoliosis (AIS) after instrumented fusion. As the spine functions as a unit, alterations to segments above or below can disturb the delicate balance that exists in the mobility of the spinal column. These motion alterations are poorly understood, and the short- and long-term effects of disrupted mechanics are also poorly understood. Further research on motion alterations and disc health is warranted. We plan to study patients at their 10 year or greater follow-up visit and collecting motion bending films along with MRI data to assess disc health status. This research is currently unfunded.
3D Research in AIS
Adolescent idiopathic scoliosis (AIS) is a complex three-dimensional (3D) deformation of the trunk: a complex 3D ‘’rotatory’’ or ‘’torsional’’ deformity of the spine and the surgical treatment of AIS should be done in 3D and according to 3D principles of correction. Fortunately, recent developments in digital radiography such as the EOS system allow the possibility to obtain fast, reliable, minimally-irradiating and cost-effective 3D reconstructions of the spine, rib cage and pelvis of subjects with AIS. We plan to develop our Idiopathic Scoliosis registry into the largest series of 3D data for scoliosis evaluation, treatment and outcomes evaluations. Our efforts to advance care using 3D evaluation techniques and 3D outcomes analyses are currently limited in funding.