Pedicle Screw Usage in Conventional Fixation Pattern Constructs Compared to Thoracic Hook Constructs in Scoliosis

Adolescent Idiopathic Scoliosis Clinical Trial

Official title:

Pedicle Screw Usage in Conventional Fixation Pattern Constructs Compared to Thoracic Hook Constructs in Adolescent Idiopathic Scoliosis Patients and Neuromuscular Ambulators

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01581021
• Other study ID #: 2005-0110
• Status: Completed
• Phase: N/A
• First received: April 13, 2012
• Last updated: December 13, 2013
• Start date: August 2005
• Est. completion date: August 2011

Study information

• Verified date: December 2013
• Source: University of Mississippi Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Scoliosis is a deformity in which there is an abnormal curvature of the spine. Surgery is the main method of correcting this deformity. Rods are attached to the spine to make it strait. There are two ways to fix these rods to the bone of the spine: laminar hooks or pedicle screws. Hooks are an older form of fixation and do not penetrate the bone, but are instead placed over a part of the vertebra called the lamina. Screws are newer and do penetrate the bone. Screws are placed into the part of the vertebra called the pedicle. Most surgeons think screws correct scoliosis better than hooks. The current literature agrees that screws are better for deformity correction in the lumbar spine and patients with severe deformity. There is disagreement in the literature regarding which works better in the thoracic spine in less severe deformity. There are no randomized, controlled trials in the literature that examine whether constructs that use hooks in the thoracic spine and screws in the lumbar spine (called hybrid constructs) work as well as all-screw constructs. This clinical study is a randomized controlled trial being conducted to evaluate treatment outcomes in patients with scoliosis undergoing surgical correction for their curves using either all-screw or hybrid constructs as fixation devices. The study population is limited to those with less severe deformity and the investigators' hypothesis is that hybrid constructs will be as acceptable as screws in terms of correction.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years to 21 Years

Eligibility

Inclusion Criteria:

• Primary diagnosis of adolescent idiopathic scoliosis or neuromuscular scoliosis

• Fusion to include six of more levels in thoracic, thoracolumbar, or lumbar region

• Less than 21 years of age

• Able to undergo surgery based on physical exam, medical history, and surgeon judgement

• Willing to comply with the follow-up clinical and radiographic evaluation schedules

• Informed consent signed by patient and parent or legal guardian

Exclusion Criteria:

• Scoliosis with curvature greater than 100 degrees or less than 40

• Smaller juvenile subjects weighing less than 30 kg

• Rigid curves

• Infection in the disc or spine, past or present

• Subject is pregnant

• Evidence of abuse of alcohol and/or illicit drugs

• Subject is prisoner

• Subject has evidence of tumor(s), malignant disease or other significant illness with decreased life expectancy

• Subject is immunocompromised or being treated with immunosuppressive agents

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adolescent Idiopathic Scoliosis
• Scoliosis

Intervention

Device:
• Pedicle screws
Screws that are placed into the pedicle of vertebral body.
• Laminar Hooks
Hooks are placed over the lamina of the vertebral body

Locations

Country	Name	City	State
United States	University of Mississippi Medical Center	Jackson	Mississippi

Sponsors (1)

Lead Sponsor	Collaborator
University of Mississippi Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Main Thoracic Cobb	X-rays measures the degree of curve in the thoracic spine.	24 months post-operative	No
Primary	Rotation	The degree to which the spinal column is rotated from its normal position will be assessed.	24 months post-operative	No
Primary	Scoliosis Research Society-30 Survey	Participants were administered a validated survey for evaluating patient quality of life and satisfaction with treatment. Total SRS-30 scores (max = 150) and the domains: function (max = 35), pain (max = 30), self-image (max = 45), mental health (max = 25), and satisfaction with management (max = 15) were analyzed on a scale from 1 (worst) to 5 (best). The mean was obtained by dividing maximum possible score by the number of questions answered.	24 months post-operative	No
Secondary	Mobilization and Pain Survey	Using a numeric rating scale (0 = no pain and 10 = unbearable pain), patients were asked to estimate their experienced pain while at rest and when mobile by specifying a number on the scale.	24 months post-operative	No