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

Degenerative Disc Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02104141
• Other study ID #: ROIA100
• Status: Completed
• Start date: November 2013
• Est. completion date: December 2016

Study information

• Verified date: April 2019
• Source: LDR Spine USA
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: December 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Degenerative Disc Disease
• Intervertebral Disc Degeneration

Intervention

Device:
• ROIA Interbody Cage with VerteBRIDGE plating

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
LDR Spine USA

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Fusion	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	12 months after device implantation
Secondary	Mean Oswestry Disability Index	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	12 months after device implantation