Scoliosis

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Perioperative Outcomes of Multilevel Posterior Spinal Fusion In Adolescent Scoliosis With T. E.

Clinical Trial

Offered by: Nemours
Location: Delaware Valley

Trial Name

Perioperative Outcomes of Multilevel Posterior Spinal Fusion In Adolescent Scoliosis With T. E.

What is the trial about?

The purpose of this study is to compare the amount of blood loss during posterior spinal fusion surgery using 2 different surgical instruments: a traditional cutting device (during Phase I) and ultrasonic energy cutting device-OSTEOVUE™ Spine Soft Tissue Dissector (during Phase II).

Who can participate?

Patients between 10 and 21 years of age, diagnosed with neuromuscular scoliosis associated with cerebral palsy or with adolescent idiopathic scoliosis (AIS) indicated for primary Posterior Spinal Fusion (PSF).

What is involved?

Participants will be screened, consented, and enrolled any time between the scheduling of their PSF surgery and hospital admission. Last study observations/recordings will be made at hospital discharge; hence, overall duration of participation will be approximately 35-40 days per participant (from informed consent to hospital discharge). There are no follow-up visits required for this study.

No matter what group you are a part of, the levels of hemoglobin (a protein found in red blood cells that carries oxygen) will be tested before surgery.

During surgery and before discharge from the hospital, three additional blood tests (2 during your child’s surgery and one at the time of hospital discharge) will be done. These additional tests will not exceed 15 cc in total equivalent to about 1 tablespoon of blood from the vein of your child for each test.

Contact Nemours Clinical Trials

Trial Name:

Perioperative Outcomes of Multilevel Posterior Spinal Fusion In Adolescent Scoliosis With T. E.

IRB: 700339

Contact Information

(800) 354-5690
ClinicalTrials@nemours.org