INDEPENDENCE Spacer for Lumbar Fusion

Circumferential Lumbar Spinal Fusion for Treatment of Degenerative Disc Disease: A Prospective, Non-Randomized Clinical Study

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.

Study Overview

• Status: Completed
• Conditions: Degenerative Disc Disease
• Intervention / Treatment: Device: INDEPENDENCE

Detailed Description

A total of thirty subjects will be enrolled at Scott & White Healthcare. The INDEPENDENCE spacer will be filled with autogenous bone graft material. The devices subject to this Agreement have received 510(k) clearance from the FDA for the indications specified in this Agreement.

Patients will be followed for 2 years with evaluations at the following time intervals: preoperatively (within 2 months of surgery) and postoperatively at 6 weeks, 3 months, 6 months, 12 months, and 24 months.

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• United States
  • Texas
    • Temple, Texas, United States, 76508
      • Scott & White Healthcare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

Inclusion Criteria:

• • 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

Exclusion Criteria:

• • 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Self- Assessment for pain scores	VAS questionnaires to be completed at every follow-up timepoint	2 years
Patient Satisfaction	Questionnaire to be completed at every follow-up timepoint	2 years

Collaborators and Investigators

• Sponsor: Globus Medical Inc
• Investigators: Principal Investigator: Christopher Chaput, MD, Scott & White Healthcare

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: November 18, 2014
• First Submitted That Met QC Criteria: November 20, 2014
• First Posted (Estimate): November 24, 2014

Study Record Updates

• Last Update Posted (Estimate): August 10, 2016
• Last Update Submitted That Met QC Criteria: August 9, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Intervertebral Disc Degeneration
• Other Study ID Numbers: RGC11-010-001-PL_C