Clinical Trials for Kyphosis
Different clinical trials are being conducted to evaluate and treat kyphosis. Kyphosis can lead to spinal deformity in young children, adolescents, and adults. Adolescent kyphosis is sometimes called Scheuermann’s disease. The causes of kyphosis include muscular and neurological diseases, osteoporotic vertebral compression fractures, degenerative disc disease, injury, and habitual poor posture.
Clinical trials are human investigational studies that are regulated and follow specific guidelines. Research studies about kyphosis include more effective methods to measure kyphotic curves, prevent curve progression, treat deformity, and improve quality of life.
Who Conducts a Clinical Trial for Kyphosis?
A clinical trial investigator is responsible for overseeing and making sure the clinical trial is conducted according to approved guidelines. Depending on the size of the clinical trial—meaning the number of patient participants—the study may involve two or more investigators and many clinical trial coordinators, doctors, nurses, and patient advocates.
Qualifying to Participate
Each clinical trial, whether it is for kyphosis or a different back or neck disorder, is designed with guidelines for patient selection called inclusion and exclusion criteria. These criteria can be very specific. To give you an example, let’s say a clinical trial coordinator requires only female patients between the ages of 10 and 14 with an abnormal kyphosis of 25 degrees, and who plan to undergo spine surgery to stop curve progression.
Although many patients qualify to participate, a few are ineligible because the exclusion criteria may include active infection or previous spinal surgery.
When looking at a clinical trial for kyphosis, review the inclusion and exclusion criteria carefully; the above is simply an example, and every trial will have different criteria.
Why Are the Guidelines So Specific for Kyphosis Clinical Trials?
Safety is most important. The sponsor of a clinical trial (eg, a university) has performed due diligence well in advance of the study entering the actively recruiting phase. The guidelines for a clinical trial are so specific to ensure safety and to make sure that the trial results are the most useful to the medical community—and eventually to patients, since clinical trials for kyphosis are done to improve care.