Clinical Trials for Scoliosis
There are many clinical trials for scoliosis being conducted. Scoliosis is an abnormal sideward curve of the spine. It can affect youngsters, adolescents, and adults. Sometimes the cause is known, such as a neurologic or muscular problem. When the cause is not known, it is termed idiopathic scoliosis.
Scoliosis clinical trials study types of scoliosis such as adolescent idiopathic scoliosis and adult degenerative scoliosis. Research also studies curve size and shape, variables of onset (ie, age and gender), genetic predisposition of occurrence among family members, safety and effectiveness of non-operative (eg, bracing) and surgical treatment (eg, spinal fusion and instrumentation), quality of life issues, and many other associated topics.
Many research studies have improved the diagnosis, management and treatment of scoliosis. A huge advance involves genetics—inheritance markers can help predict the severity of a scoliosis and therefore, improve care earlier.
Am I a Candidate for a Scoliosis Clinical Trial?
The answer to that question depends on how you fit a particular clinical study’s protocol. The protocol is the study plan and includes strict guidelines that govern patient (the participant) selection. Factors often considered are the prospective candidate’s gender, age, number of curves, size, shape, and result of previous treatment (if any).
Who Monitors a Clinical Trial for Scoliosis?
Before a clinical trial for scoliosis can begin any activity, such as recruiting participants, it must be approved by an Institutional Review Board (IRB). IRBs follow regulations set forth by the United States Food and Drug Administration (FDA). Both entities are concerned with the safety and welfare of patients, including legal and moral issues.
The Principal Investigator is often a scoliosis specialist, such as a board-certified and fellowship-trained orthopaedic spine surgeon who may also be affiliated with an academic institution (eg, university medical center). One or several Clinical Trial Coordinators and other medical and research staff may be involved in monitoring and conducting the scoliosis clinical trial.