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Orthopaedic Surgery

Prospective Pediatric Kyphosis Study

Purpose

The main objective of this study is to assess outcome measures in patients with pediatric kyphosis being treated nonoperatively or operatively with current surgical techniques.

In order to do this, the study will focus on the use of physician-based and patient-based measures. Patient-based outcome measure is a short-hand term used to refer to a collection of questionnaires, interviews and other related ways of evaluating health from the patient's perspective. These instruments are completed by the patients themselves or sometimes when necessary, by their caregivers. As for the physician-based measures, they are the more traditional tools that every physician uses when treating their patients. The PPKS study hopes to compare the different treatment approaches for this condition, using both the patient-based outcome measures and the more traditional, physician-based assessments. From this comparison, we can explore the relative pros and cons of each of these valid therapeutical options in orthopaedic intervention in this unique population.

A secondary objective of this study is to obtain data on currently available surgical approaches to treat pediatric kyphosis in the thoracic spine. The investigation will attempt to answer many of the questions that the multiple approaches to the treatment of pediatric kyphosis pose to surgeons in general, such as from where should the approach be done, how do we overcome the different problems that these condition may show, or if any of these techniques is better than the others.

The last objective we have in this study is to determine if the actual patient-based outcome measurement instruments available are reliable or not.

All children and adolescents (ages 8-17.9 years) with a primary diagnosis of pediatric kyphosis will be eligible to participate in this study. Some conditions include, but are not limited to, Scheuermann's kyphosis, postlaminectomy kyphosis, postural kyphosis, postinfectious kyphosis, postradiation kyphosis, posttraumatic and other ambulatory individuals with segmental or global kyphosis. Congenital kyphosis is purposely excluded from this study. Patients who require surgery will need to have it done before 21 years of age to be elligible for this study.

Eligible patients and their caregivers will be asked if they are willing to participate in this study. After obtaining informed consent, they will be enrolled into the study at the point of contact by the consulting pediatric orthopaedic surgeon and/or a study coordinator. This initial visit with the surgeon will involve patient enrollment into the study and a Preop (surgical patients) or Initial (non-surgical) assessment both by the physician and the patient and his or her parents.

Patients who require surgery will be asked to come in for another four postoperative evaluations (6weeks, 1year, 2 years, and 5 years after surgery). These evaluations are also part of the normal treatment follow-up.

Patients who do not require surgery will be asked to come in after 1, 2 and 5 years, for follow-up and Post-initial evaluation.

Preop/Initial
Surgical: 3
Non-Surgical: 1
Total: 4

6 weeks
Surgical: 1
Non-Surgical: 0
Total: 1

1 Year
Surgical: 0
Non-Surgical: 0
Total: 0

2 Years
Surgical: 0
Non-Surgical: 0
Total: 0

5 Years
Surgical: 0
Non-Surgical: 0
Total: 0