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

Completed

• Conditions: Degenerative Disc Disease
• Interventions: Device: ROIA Interbody Cage with VerteBRIDGE plating

• Registration Number: NCT02104141
• Lead Sponsor: LDR Spine USA

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2014-04-01
• Study First Submitted QC: 2014-04-03
• Study First Posted: 2014-04-04
• Primary Completion: 2016-04
• Study Completion: 2016-12
• Results First Submitted: 2019-01-15
• Results First Submitted QC: 2019-01-15
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-12
• Results First Posted: 2019-04-16
• Last Update Posted: 2019-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Operated Subjects	ROIA Interbody Cage with VerteBRIDGE plating	ROIA Interbody Cage with VerteBRIDGE plating

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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