INDEPENDENCE Spacer for Lumbar Fusion

Degenerative Disc Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02299323
• Other study ID #: RGC11-010-001-PL_C
• Status: Completed
• Phase: N/A
• First received: November 18, 2014
• Last updated: August 9, 2016
• Start date: January 2012
• Est. completion date: August 2016

Study information

• Verified date: August 2016
• Source: Globus Medical Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Degenerative Disc Disease
• Intervertebral Disc Degeneration

Intervention

Device:
• INDEPENDENCE
Lumbar Integrated plate and spacer, with percutaneous screws and rods.

Locations

Country	Name	City	State
United States	Scott & White Healthcare	Temple	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Globus Medical Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Patient Self- Assessment for pain scores	VAS questionnaires to be completed at every follow-up timepoint	2 years	No
Secondary	Patient Satisfaction	Questionnaire to be completed at every follow-up timepoint	2 years	No