Trial Outcomes & Findings for Retrospective/Prospective Data Collection on the LDR ROIA Interbody Fusion Device With VerteBRIDGE Plating (NCT NCT02104141)

Last Updated: 2019-04-24

Results Overview

Fusion was assessed utilizing both AP and flexion/extension radiographs. Fusion was noted when all three of the criteria were present: 1) presence of bridging bone as identified by radiography, 2)Less than 5 degrees of segmental motion on flexion/extension radiographs, and 3) Less than 3 mm of A/P translation on flexion/extension radiographs

Recruitment status

COMPLETED

Target enrollment

51 participants

Primary outcome timeframe

12 months after device implantation

Results posted on

2019-04-24

Participant Flow

Participant milestones

Participant milestones
Measure	Operated Subjects ROIA Interbody Cage with VerteBRIDGE plating
Overall Study STARTED	51
Overall Study COMPLETED	51
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Retrospective/Prospective Data Collection on the LDR ROIA Interbody Fusion Device With VerteBRIDGE Plating

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Operated Subjects n=51 Participants ROIA Interbody Cage with VerteBRIDGE plating
Age, Continuous	50.7 Years STANDARD_DEVIATION 11.9 • n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants
Race (NIH/OMB) White	47 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	51 Participants n=5 Participants
BMI (kg/mg^2)	28.4 kg/mg^2 STANDARD_DEVIATION 4.6 • n=5 Participants
Current smoker	9 Participants n=5 Participants
Previous Lumbar Spine Surgery	19 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months after device implantation

Outcome measures

Outcome measures
Measure	Operated Subjects n=51 Participants ROIA Interbody Cage with VerteBRIDGE plating
Number of Participants With Fusion	50 Participants

SECONDARY outcome

Timeframe: 12 months after device implantation

The Oswestry Disability Index (ODI) is and index to quantify disability for low back pain. There are 50 possible points which are multiplied by 2 to arrive at a percentage score. Zero is equated with no disability and 100 is the maximum disability possible

Outcome measures

Outcome measures
Measure	Operated Subjects n=51 Participants ROIA Interbody Cage with VerteBRIDGE plating
Mean Oswestry Disability Index	28.9 score on a scale Standard Deviation 22.3

Adverse Events

Operated Subjects

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Operated Subjects n=51 participants at risk ROIA Interbody Cage with VerteBRIDGE plating
Musculoskeletal and connective tissue disorders Lower extremity neuropathy	5.9% 3/51 • Number of events 3 • From enrollment through final follow up (12 month) visit An adverse event is defined as any change from baseline in a subject's condition during the clinical study. This includes events that are related to the device as well as events that are not related to the device.
Renal and urinary disorders Urinary Tract Infection	2.0% 1/51 • Number of events 1 • From enrollment through final follow up (12 month) visit An adverse event is defined as any change from baseline in a subject's condition during the clinical study. This includes events that are related to the device as well as events that are not related to the device.
Musculoskeletal and connective tissue disorders Lower back pain	3.9% 2/51 • Number of events 2 • From enrollment through final follow up (12 month) visit An adverse event is defined as any change from baseline in a subject's condition during the clinical study. This includes events that are related to the device as well as events that are not related to the device.

Additional Information

Clinical Affairs

Zimmer Biomet Spine

Phone: 303-501-8571

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place