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

L

LDR Medical

Status

Completed

Conditions

Degenerative Disc Disease

Treatments

Device: ROIA Interbody Cage with VerteBRIDGE plating

Study type

Observational

Funder types

Industry

Identifiers

NCT02104141
ROIA100

Details and patient eligibility

About

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.

Enrollment

51 patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

51 participants in 1 patient group

Operated Subjects
Description:
ROIA Interbody Cage with VerteBRIDGE plating
Treatment:
Device: ROIA Interbody Cage with VerteBRIDGE plating

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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