Trial Outcomes & Findings for Study of an Expandable Interbody Device for the Lumbar Spine (NCT NCT02075554)

NCT ID: NCT02075554

Last Updated: 2021-02-03

Results Overview

Inter-vertebral disc height in millimetres at 24 month follow up.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 58 participants
• Primary outcome timeframe: 24 months
• Results posted on: 2021-02-03

Participant Flow

The protocol was approved to enroll 60 patients but only 58 patients were enrolled.

Participant milestones

Measure	CALIBER 1 or 2 levels of Degenerative Disc Disease between L2 and S1, treated with transforaminal interbody fusion CALIBER: Expandable interbody spacer
Overall Study STARTED	58
Overall Study COMPLETED	43
Overall Study NOT COMPLETED	15

Reasons for withdrawal

Measure	CALIBER 1 or 2 levels of Degenerative Disc Disease between L2 and S1, treated with transforaminal interbody fusion CALIBER: Expandable interbody spacer
Overall Study Lost to Follow-up	7
Overall Study Withdrawal by Subject	5
Overall Study Physician Decision	3

Baseline Characteristics

Study of an Expandable Interbody Device for the Lumbar Spine

Baseline characteristics by cohort

Measure	CALIBER n=43 Participants 1 or 2 levels of DDD between L2 and S1, treated with transforaminal interbody fusion CALIBER: Expandable interbody spacer
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	31 Participants n=5 Participants
Age, Categorical >=65 years	12 Participants n=5 Participants
Age, Continuous	54 years n=5 Participants
Sex: Female, Male Female	31 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Region of Enrollment United States	43 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 months

Population: Not all patients had x ray images to measure at 24 month follow up. A total of 33 surgical levels were measured from 29 patients.

Inter-vertebral disc height in millimetres at 24 month follow up.

Outcome measures

Measure	CALIBER n=33 Surgical Levels 1 or 2 levels of DDD between L2 and S1, treated with transforaminal interbody fusion CALIBER: Expandable interbody spacer
Fusion and Disc Height Maintenance	11.60 millimetres Interval 8.62 to 15.6

PRIMARY outcome

Timeframe: 24 months

Population: Only 29 patients were available for fusion assessment at 24 months, for a total of 33 surgical levels.

An assessment of the fusion status of surgically treated spinal levels.

Outcome measures

Measure	CALIBER n=33 Surgical Levels 1 or 2 levels of DDD between L2 and S1, treated with transforaminal interbody fusion CALIBER: Expandable interbody spacer
Fusion Assessment	33 Surgical Levels

SECONDARY outcome

Timeframe: Upto 24 mo

Population: Not all patients completed the Oswestry Disability Index questionnaire at 24 month follow up, leaving 38 responses.

Oswestry Disability Index. A 10 item questionnaire with responses scored 0 to 5 and then presented as a percentage score from 0 to 100, with higher scores denoting more disability.

Outcome measures

Measure	CALIBER n=38 Participants 1 or 2 levels of DDD between L2 and S1, treated with transforaminal interbody fusion CALIBER: Expandable interbody spacer
Patient Self Assessment	18.79 scores on a scale Interval 0.0 to 66.0

SECONDARY outcome

Timeframe: 24 months

Population: 38 patients completed the question at 24 month follow up

A visual scale from 0 to 100 in which the patient responds with their pain level by marking on the line, higher as more severe pain.

Outcome measures

Measure	CALIBER n=38 Participants 1 or 2 levels of DDD between L2 and S1, treated with transforaminal interbody fusion CALIBER: Expandable interbody spacer
Visual Analog Scale for Back Pain	10.71 score on a scale out of 100 Interval 0.0 to 78.0

Adverse Events

CALIBER

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

Brandon Bucklen

Globus Medical Inc.

Phone: 610-930-1800

Email: bbucklen@globusmedical.com

Results disclosure agreements

• Principal investigator is a sponsor employee PI may release for publication with Sponsor's prior approval.
• Publication restrictions are in place

Restriction type: OTHER