INDEPENDENCE Spacer for Lumbar Fusion

NCT02299323 | Completed

• 1 other identifier: RGC11-010-001-PL_C
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to evaluate radiographic outcomes, intra-operative parameters, clinical outcomes, and patient satisfaction following circumferential fusion using the INDEPENDENCE® integrated plate and spacer with REVOLVE® Stabilization System for the treatment of severe low back pain due to lumbar disc degeneration unresponsive to 6 months of non-operative treatment.

Conditions

Degenerative Disc Disease

Outcome Measures

Primary Outcomes (1)

• Radiographic fusion evaluation

  Anterior Posterior / Lateral, Flexion-Extension X-rays at every timepoint will be evaluated for signs of fusion, pseudoarthrosis and implant subsidence or migration

  2 years

Secondary Outcomes (2)

• Patient Self- Assessment for pain scores

  2 years

• Patient Satisfaction

  2 years

Interventions

INDEPENDENCE DEVICE

Lumbar Integrated plate and spacer, with percutaneous screws and rods.

Eligibility Criteria

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

Study Population

Patients between ages 18 and 65 withsevere low back pain due to lumbar disc degeneration unresponsive to 6 months of non-operative treatm

You may qualify if:

• Objective evidence of degenerative disc disease at 1 or 2 level(s) between L2 and S1 with degeneration confirmed by patient history and radiographic examination
• Experience pain, functional deficit and/or neurological deficit for a minimum of six months
• Unresponsiveness to documented non-surgical treatment modalities for a minimum of six months and/or presentation with progressive symptoms of nerve root or spinal cord compression prior to enrollment
• At least 18 years of age and maximum 65 years of age
• Ability to provide Informed Consent for study participation and to return for all follow-up visits

You may not qualify if:

• Presence of systemic or localized infection at the site of surgery
• More than 2 levels to be instrumented
• Previous fusion attempt at the involved level(s)
• More than three previous open, posterior, lumbar spinal surgical procedures at the involved level(s)
• Trauma at the level(s) to be fused
• More than grade 1 spondylolisthesis
• Previous documentation of osteopenia, osteoporosis, or osteomalacia to a degree that spinal instrumentation would be contraindicated
• Diagnosis of a condition or requires postoperative medication(s), which may interfere with bony/soft tissue healing
• Presence of a disease entity or condition which totally precludes possibility of bony fusion (e.g. metastatic cancer, HIV, long term use of steroids, etc.)
• Immunosuppressive disorder
• Pregnant or interested in becoming pregnant during the duration of the study
• History of substance abuse (drugs or alcohol)
• Any known allergy to a metal alloy
• Mentally incompetent or prisoner
• Currently a participant in another study

Sponsors & Collaborators

• Globus Medical Inc: lead

Study Sites (1)

Scott & White Healthcare

Temple, Texas, 76508, United States

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Christopher Chaput, MD

  Scott & White Healthcare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2014
• First Posted: November 24, 2014
• Study Start: January 1, 2012
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: August 10, 2016

Record last verified: 2016-08

Locations

US (1)