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

• Sponsor: University of Mississippi Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT01581021
• Collaborator: (none)
• Enrollment: 58
• Location: 1
• Arms: 2
• Duration (Months): 72
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Adolescent Idiopathic Scoliosis	Device: Pedicle screws; Device: Laminar Hooks	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 58 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Pedicle Screw Usage in Conventional Fixation Pattern Constructs Compared to Thoracic Hook Constructs in Adolescent Idiopathic Scoliosis Patients and Neuromuscular Ambulators
• Study Start Date: Aug 1, 2005
• Actual Primary Completion Date: Aug 1, 2011
• Actual Study Completion Date: Aug 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Thoracic Pedicle Screws Group treated with pedicle screws in the thoracic spine	Device: Pedicle screws; Screws that are placed into the pedicle of vertebral body.
Active Comparator: Laminar Hooks Group treated with hooks in the thoracic spine	Device: Laminar Hooks; Hooks are placed over the lamina of the vertebral body

Outcome Measures

Primary Outcome Measures

1. Main Thoracic Cobb [24 months post-operative]

   X-rays measures the degree of curve in the thoracic spine.

2. Rotation [24 months post-operative]

   The degree to which the spinal column is rotated from its normal position will be assessed.

3. Scoliosis Research Society-30 Survey [24 months post-operative]

   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.

Secondary Outcome Measures

1. Mobilization and Pain Survey [24 months post-operative]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 7 Years to 21 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Mississippi Medical Center	Jackson	Mississippi	United States	39202

Sponsors and Collaborators

• University of Mississippi Medical Center

Investigators

• Principal Investigator: Lawrence L Haber, MD, University of Mississippi Medical Center
• Study Director: Erika D Womack, BS MS, University of Mississippi Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lawrence Haber, Chief Pediatric Orthopaedics/Associate Professor, University of Mississippi Medical Center
• ClinicalTrials.gov Identifier: NCT01581021
• Other Study ID Numbers: 2005-0110
• First Posted: Apr 19, 2012
• Last Update Posted: Feb 3, 2014
• Last Verified: Dec 1, 2013

• Keywords provided by Lawrence Haber, Chief Pediatric Orthopaedics/Associate Professor, University of Mississippi Medical Center: randomized; controlled; hooks; screws
• Additional relevant MeSH terms: Scoliosis

Study Results

Participant Flow

Recruitment Details	Patients with adolescent idiopathic scoliosis were recruited at a University Mississippi Medical center clinic from Nov. 2005 to Dec. 2008.
Pre-assignment Detail	After consent, the patient was given an identification number with the computer-generated randomized construct assignment. Enrolled participants might have been excluded from the study due to not being randomized.

Arm/Group Title	Thoracic Pedicle Screws	Laminar Hooks
Arm/Group Description	Group treated with pedicle screws in the thoracic spine	Group treated with hooks in the thoracic spine
Period Title: Overall Study
STARTED	29	29
COMPLETED	19	18
NOT COMPLETED	10	11

Baseline Characteristics

Arm/Group Title	Thoracic Pedicle Screws	Laminar Hooks	Total
Arm/Group Description	Group treated with pedicle screws in the thoracic spine	Group treated with hooks in the thoracic spine	Total of all reporting groups
Overall Participants	29	29	58
Age (Count of Participants)
<=18 years	28 96.6%	27 93.1%	55 94.8%
Between 18 and 65 years	1 3.4%	2 6.9%	3 5.2%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	13.62 (2.21)	14.17 (2.21)	13.90 (2.21)
Sex: Female, Male (Count of Participants)
Female	25 86.2%	22 75.9%	47 81%
Male	4 13.8%	7 24.1%	11 19%
Region of Enrollment (participants) [Number]
United States	29 100%	29 100%	58 100%

Outcome Measures

1. Primary Outcome

Title	Main Thoracic Cobb
Description	X-rays measures the degree of curve in the thoracic spine.
Time Frame	24 months post-operative

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Thoracic Pedicle Screws	Laminar Hooks
Arm/Group Description	Group treated with pedicle screws in the thoracic spine	Group treated with hooks in the thoracic spine
Measure Participants	19	18
Preoperative	55 (6)	58 (8)
4 weeks post-operative	15 (7)	18 (8)
24 months at final follow-up	14 (6)	23 (8)

2. Primary Outcome

Title	Rotation
Description	The degree to which the spinal column is rotated from its normal position will be assessed.
Time Frame	24 months post-operative

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Thoracic Pedicle Screws	Laminar Hooks
Arm/Group Description	Group treated with pedicle screws in the thoracic spine	Group treated with hooks in the thoracic spine
Measure Participants	19	18
Preoperative	15 (4)	14 (4)
24 month post-operative	7 (3)	11 (5)

3. Primary Outcome

Title	Scoliosis Research Society-30 Survey
Description	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.
Time Frame	24 months post-operative

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Thoracic Pedicle Screws	Laminar Hooks
Arm/Group Description	Group treated with pedicle screws in the thoracic spine	Group treated with hooks in the thoracic spine
Measure Participants	19	18
Preoperative	3.9 (0.2)	3.9 (0.2)
24 months post operative	4.0 (0.2)	4.1 (0.3)

4. Secondary Outcome

Title	Mobilization and Pain Survey
Description	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.
Time Frame	24 months post-operative

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Thoracic Pedicle Screws	Laminar Hooks
Arm/Group Description	Group treated with pedicle screws in the thoracic spine	Group treated with hooks in the thoracic spine
Measure Participants	19	18
Resting Pain Scale Preoperative	2 (2.31)	1.96 (2.49)
Resting Pain Scale 24 mo Post-operative	1.25 (1.86)	1.0 (1.41)
Mobilization Preoperative Pain Scale	2.433 (2.74)	2.16 (2.34)
Mobilization 24 mo Postoperative Pain Scale	1.25 (2.17)	1.6 (1.55)

Adverse Events

Time Frame	No adverse events occurred.
Arm/Group Title	Thoracic Pedicle Screws		Laminar Hooks
Arm/Group Description	Group treated with pedicle screws in the thoracic spine		Group treated with hooks in the thoracic spine
All Cause Mortality
	Thoracic Pedicle Screws		Laminar Hooks
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Thoracic Pedicle Screws		Laminar Hooks
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/29 (0%)		0/29 (0%)
Other (Not Including Serious) Adverse Events
	Thoracic Pedicle Screws		Laminar Hooks
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/29 (0%)		0/29 (0%)

Limitations/Caveats

The design of this study is a computer-generated randomized trial. Initially, the first 3 participants were not computer-randomized and therefore, these subjects had to be removed from the study.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.