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

• Sponsor: LDR Spine USA (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02104141
• Collaborator: (none)
• Enrollment: 51
• Duration (Months): 37

Study Details

Study Description

Brief Summary

The purpose of this combination retrospective and prospective post market study is to examine the short term safety and efficacy of the ROI-A® interbody fusion device with VerteBRIDGE® plates to treat single and two-level degenerative disc disease between L2 and S1, with a focus on fusion rates and patient outcomes.

Condition or Disease	Intervention/Treatment	Phase
Degenerative Disc Disease	Device: ROIA Interbody Cage with VerteBRIDGE plating

Study Design

• Study Type: Observational
• Actual Enrollment: 51 participants
• Observational Model: Cohort
• Time Perspective: Other
• Official Title: An Open Label, Multicenter, Clinical Study of the Safety and Efficacy of the LDR Spine ROI-A Interbody Fusion System Using the VerteBRIDGE™ Plating System
• Study Start Date: Nov 1, 2013
• Actual Primary Completion Date: Apr 1, 2016
• Actual Study Completion Date: Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Operated Subjects ROIA Interbody Cage with VerteBRIDGE plating	Device: ROIA Interbody Cage with VerteBRIDGE plating

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Fusion [12 months after device implantation]

   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

Secondary Outcome Measures

1. Mean Oswestry Disability Index [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Subjects must have degenerative disc disease (DDD) of the lumbar spine between L2 and S1

• Subjects may have up to a Grade 1 spondylolisthesis at the involved level(s)

• Subject must have the ROI-A® device at one level or at two contiguous levels between L2 and S1 only

• Subject should have had a minimum of 6 months non-surgical treatment prior to receiving the ROI-A® device

• Subject may have had NO MORE THAN two previous non-fusion surgeries to the lumbar spine at the same levels as the ROI-A®

• Subject must be at least 21 years of age at the time of surgery

• Subject must be willing to signed an informed consent document and return for a 12 month visit

Exclusion Criteria:

• Subject had more than Grade 1 spondylolisthesis at the operated level

• Subject is a prisoner.

• Subject was pregnant at the time of surgery.

• Subject had an active infection or sepsis at the time of surgery.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• LDR Spine USA

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: LDR Spine USA
• ClinicalTrials.gov Identifier: NCT02104141
• Other Study ID Numbers: ROIA100
• First Posted: Apr 4, 2014
• Last Update Posted: Apr 24, 2019
• Last Verified: Apr 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by LDR Spine USA: DDD; lumbar spine; fusion rate; degenerative disc disease
• Additional relevant MeSH terms: Intervertebral Disc Degeneration

Study Results

Participant Flow

Arm/Group Title	Operated Subjects
Arm/Group Description	ROIA Interbody Cage with VerteBRIDGE plating
Period Title: Overall Study
STARTED	51
COMPLETED	51
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Operated Subjects
Arm/Group Description	ROIA Interbody Cage with VerteBRIDGE plating
Overall Participants	51
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	50.7 (11.9)
Sex: Female, Male (Count of Participants)
Female	25 49%
Male	26 51%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	4 7.8%
White	47 92.2%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (Count of Participants)
United States	51 100%
BMI (kg/mg^2) (kg/mg^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/mg^2]	28.4 (4.6)
Current smoker (Count of Participants)
Count of Participants [Participants]	9 17.6%
Previous Lumbar Spine Surgery (Count of Participants)
Count of Participants [Participants]	19 37.3%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Fusion
Description	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
Time Frame	12 months after device implantation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Operated Subjects
Arm/Group Description	ROIA Interbody Cage with VerteBRIDGE plating
Measure Participants	51
Count of Participants [Participants]	50 98%

2. Secondary Outcome

Title	Mean Oswestry Disability Index
Description	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
Time Frame	12 months after device implantation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Operated Subjects
Arm/Group Description	ROIA Interbody Cage with VerteBRIDGE plating
Measure Participants	51
Mean (Standard Deviation) [score on a scale]	28.9 (22.3)

Adverse Events

Time Frame	From enrollment through final follow up (12 month) visit
Adverse Event Reporting Description	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.
Arm/Group Title	Operated Subjects
Arm/Group Description	ROIA Interbody Cage with VerteBRIDGE plating
All Cause Mortality
	Operated Subjects
	Affected / at Risk (%)	# Events
Total	0/51 (0%)
Serious Adverse Events
	Operated Subjects
	Affected / at Risk (%)	# Events
Total	0/51 (0%)
Other (Not Including Serious) Adverse Events
	Operated Subjects
	Affected / at Risk (%)	# Events
Total	5/51 (9.8%)
Musculoskeletal and connective tissue disorders
Lower extremity neuropathy	3/51 (5.9%)	3
Lower back pain	2/51 (3.9%)	2
Renal and urinary disorders
Urinary Tract Infection	1/51 (2%)	1

Limitations/Caveats

[Not Specified]

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.