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

NCT02104141 | Completed Results FDA Device

• 1 other identifier: ROIA100
• Study Type: observational
• Target: 51
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Degenerative Disc Disease

Keywords

DDD; lumbar spine; fusion rate; degenerative disc disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Mean Oswestry Disability Index

  12 months after device implantation

Study Arms (1)

Operated Subjects

ROIA Interbody Cage with VerteBRIDGE plating

Device: ROIA Interbody Cage with VerteBRIDGE plating

Interventions

ROIA Interbody Cage with VerteBRIDGE plating DEVICE

Operated Subjects

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects will be drawn from community surgeon practices in which the subjects have already received the device and who meet the Inclusion/Exclusion criteria.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• LDR Spine USA: lead

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Results Point of Contact

• Title: Clinical Affairs
• Organization: Zimmer Biomet Spine

tammy.stinson2@zimmerbiomet.com

303-501-8571

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2014
• First Posted: April 4, 2014
• Study Start: November 1, 2013
• Primary Completion: April 1, 2016
• Study Completion: December 1, 2016
• Last Updated: April 24, 2019
• Results First Posted: April 16, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share