Trial Outcomes & Findings for Pedicle Screw Usage in Conventional Fixation Pattern Constructs Compared to Thoracic Hook Constructs in Scoliosis (NCT NCT01581021)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

58 participants

Primary outcome timeframe

24 months post-operative

Results posted on

2014-02-03

Participant Flow

Patients with adolescent idiopathic scoliosis were recruited at a University Mississippi Medical center clinic from Nov. 2005 to Dec. 2008.

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.

Participant milestones

Participant milestones
Measure	Thoracic Pedicle Screws Group treated with pedicle screws in the thoracic spine	Laminar Hooks Group treated with hooks in the thoracic spine
Overall Study STARTED	29	29
Overall Study COMPLETED	19	18
Overall Study NOT COMPLETED	10	11

Reasons for withdrawal

Reasons for withdrawal
Measure	Thoracic Pedicle Screws Group treated with pedicle screws in the thoracic spine	Laminar Hooks Group treated with hooks in the thoracic spine
Overall Study Lost to Follow-up	4	6
Overall Study More than 2 hooks in thoracic	3	0
Overall Study Neuromuscular	2	1
Overall Study Not Randomized	1	2
Overall Study Lenke 6 Classification	0	1
Overall Study Lack of Efficacy	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Thoracic Pedicle Screws n=29 Participants Group treated with pedicle screws in the thoracic spine	Laminar Hooks n=29 Participants Group treated with hooks in the thoracic spine	Total n=58 Participants Total of all reporting groups
Age, Categorical <=18 years	28 Participants n=5 Participants	27 Participants n=7 Participants	55 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	13.62 years STANDARD_DEVIATION 2.21 • n=5 Participants	14.17 years STANDARD_DEVIATION 2.21 • n=7 Participants	13.90 years STANDARD_DEVIATION 2.21 • n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	22 Participants n=7 Participants	47 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	7 Participants n=7 Participants	11 Participants n=5 Participants
Region of Enrollment United States	29 participants n=5 Participants	29 participants n=7 Participants	58 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 months post-operative

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

Outcome measures

Outcome measures
Measure	Thoracic Pedicle Screws n=19 Participants Group treated with pedicle screws in the thoracic spine	Laminar Hooks n=18 Participants Group treated with hooks in the thoracic spine
Main Thoracic Cobb Preoperative	55 Degree Standard Deviation 6	58 Degree Standard Deviation 8
Main Thoracic Cobb 4 weeks post-operative	15 Degree Standard Deviation 7	18 Degree Standard Deviation 8
Main Thoracic Cobb 24 months at final follow-up	14 Degree Standard Deviation 6	23 Degree Standard Deviation 8

PRIMARY outcome

Timeframe: 24 months post-operative

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

Outcome measures

Outcome measures
Measure	Thoracic Pedicle Screws n=19 Participants Group treated with pedicle screws in the thoracic spine	Laminar Hooks n=18 Participants Group treated with hooks in the thoracic spine
Rotation Preoperative	15 degree Standard Deviation 4	14 degree Standard Deviation 4
Rotation 24 month post-operative	7 degree Standard Deviation 3	11 degree Standard Deviation 5

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Thoracic Pedicle Screws n=19 Participants Group treated with pedicle screws in the thoracic spine	Laminar Hooks n=18 Participants Group treated with hooks in the thoracic spine
Scoliosis Research Society-30 Survey Preoperative	3.9 units on a scale Standard Deviation 0.2	3.9 units on a scale Standard Deviation 0.2
Scoliosis Research Society-30 Survey 24 months post operative	4.0 units on a scale Standard Deviation 0.2	4.1 units on a scale Standard Deviation 0.3

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Thoracic Pedicle Screws n=19 Participants Group treated with pedicle screws in the thoracic spine	Laminar Hooks n=18 Participants Group treated with hooks in the thoracic spine
Mobilization and Pain Survey Resting Pain Scale Preoperative	2 units on a scale Standard Deviation 2.31	1.96 units on a scale Standard Deviation 2.49
Mobilization and Pain Survey Resting Pain Scale 24 mo Post-operative	1.25 units on a scale Standard Deviation 1.86	1.0 units on a scale Standard Deviation 1.41
Mobilization and Pain Survey Mobilization Preoperative Pain Scale	2.433 units on a scale Standard Deviation 2.74	2.16 units on a scale Standard Deviation 2.34
Mobilization and Pain Survey Mobilization 24 mo Postoperative Pain Scale	1.25 units on a scale Standard Deviation 2.17	1.6 units on a scale Standard Deviation 1.55

Adverse Events

Thoracic Pedicle Screws

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Laminar Hooks

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Lawrence Haber

University of Mississippi Medical Center

Phone: 601-984-6525

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place