Trial Outcomes & Findings for OsseoFix™ Spinal Fracture Reduction System in Treating Spinal Compression Fracture (NCT NCT00961714)

NCT ID: NCT00961714

Last Updated: 2022-04-28

Results Overview

Back pain improvement is defined as a reduction in VAS score of ≥ 20mm at 12 months from baseline

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 15 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2022-04-28

Participant Flow

Participant milestones

Measure	OsseoFix OsseoFix Spinal Fracture Reduction System: All enrolled into the study will be receiving the OsseoFix if meet inclusion / exclusion criteria.
Overall Study STARTED	15
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

OsseoFix™ Spinal Fracture Reduction System in Treating Spinal Compression Fracture

Baseline characteristics by cohort

Measure	OsseoFix n=15 Participants OsseoFix Spinal Fracture Reduction System: All enrolled into the study will be receiving the OsseoFix if meet inclusion / exclusion criteria.
Age, Continuous	80.5 years STANDARD_DEVIATION 8.0 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants
BMI	23.7 lb/in^2 STANDARD_DEVIATION 4.6 • n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Back pain improvement is defined as a reduction in VAS score of ≥ 20mm at 12 months from baseline

Outcome measures

Measure	OsseoFix n=13 Participants OsseoFix Spinal Fracture Reduction System: All enrolled into the study will be receiving the OsseoFix if meet inclusion / exclusion criteria.
Percentage of Participants With Back Pain Improvement at 12 Months	85 Percentage of available participants

PRIMARY outcome

Timeframe: 12 months

Functional disability improvement is defined as a reduction in ODI score by ≥ 15 points at 12 months from baseline.

Outcome measures

Measure	OsseoFix n=13 Participants OsseoFix Spinal Fracture Reduction System: All enrolled into the study will be receiving the OsseoFix if meet inclusion / exclusion criteria.
Percentage of Participants With Functional Disability Improvement at 12 Months	84.6 Percentage of available participants

PRIMARY outcome

Timeframe: 12 months

Outcome measures

Measure	OsseoFix n=13 Participants OsseoFix Spinal Fracture Reduction System: All enrolled into the study will be receiving the OsseoFix if meet inclusion / exclusion criteria.
Absence of Device Related Subsequent Interventions or Re-treatment at the Study Treated Levels	84.6 Percentage of participants

SECONDARY outcome

Timeframe: 12 months

Pain measurements determined by Visual Analog Scale (VAS) on a 100mm scale with, 0=no pain at all, to 100=worse possible pain.

Outcome measures

Measure	OsseoFix n=13 Participants OsseoFix Spinal Fracture Reduction System: All enrolled into the study will be receiving the OsseoFix if meet inclusion / exclusion criteria.
Change in Pain at 12 Months as Presented by VAS, When Compared to Baseline	-50.7 units on a scale Standard Deviation 27.2

SECONDARY outcome

Timeframe: 12 months

Improvement in functional disability as determined by ODI on a scale of 0-50, with 0=no disability at all to 50=complete disability

Outcome measures

Measure	OsseoFix n=13 Participants OsseoFix Spinal Fracture Reduction System: All enrolled into the study will be receiving the OsseoFix if meet inclusion / exclusion criteria.
Functional Disability Change at 12months From Baseline as Determined by ODI	-39.9 units on a scale Standard Deviation 16.8

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Measure	OsseoFix n=15 Participants OsseoFix Spinal Fracture Reduction System: All enrolled into the study will be receiving the OsseoFix if meet inclusion / exclusion criteria.
Any Cement Extravasation Before Discharge	1 participants

Adverse Events

OsseoFix

Serious events: 3 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Measure	OsseoFix n=15 participants at risk OsseoFix Spinal Fracture Reduction System: All enrolled into the study will be receiving the OsseoFix if meet inclusion / exclusion criteria.
Nervous system disorders Obstructive Hydrocephalus	6.7% 1/15
Renal and urinary disorders Pyelonephritis	6.7% 1/15
Musculoskeletal and connective tissue disorders Weakness	6.7% 1/15

Other adverse events

Measure	OsseoFix n=15 participants at risk OsseoFix Spinal Fracture Reduction System: All enrolled into the study will be receiving the OsseoFix if meet inclusion / exclusion criteria.
Cardiac disorders Cardiac Arrest	6.7% 1/15
Musculoskeletal and connective tissue disorders Compression Fracture	6.7% 1/15
Musculoskeletal and connective tissue disorders Elbow Abrasion	6.7% 1/15
General disorders Fall	6.7% 1/15
Musculoskeletal and connective tissue disorders Left Trochanter Bursitis	6.7% 1/15
Metabolism and nutrition disorders Nausea	6.7% 1/15
Nervous system disorders Pain	13.3% 2/15
Musculoskeletal and connective tissue disorders Rib Fracture	13.3% 2/15
Musculoskeletal and connective tissue disorders Sacroiliitis	6.7% 1/15
Cardiac disorders Thoracis Abscess	6.7% 1/15
Infections and infestations Urinary Tract Infection	6.7% 1/15

Additional Information

Glen Seidner, Clinical Affairs

Alphatec Spine, Inc.

Phone: 760-494-6789

Email: gseidner@alphatecspine.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place