Study of an Expandable Interbody Device for the Lumbar Spine

Degenerative Disc Disease Clinical Trial

— CALIBER  

Official title:

Efficacy and Safety of Expandable Spacer in the Treatment of Degenerative Disc Disease Using the Minimally Invasive Transforaminal Lumbar Interbody Fusion Surgical Approach

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02075554
• Other study ID #: RGC10-009-001-PL_H_2
• Status: Completed
• Phase: N/A
• Start date: July 2012
• Est. completion date: February 2017

Study information

• Verified date: February 2021
• Source: Globus Medical Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to evaluate the safety and efficacy of CALIBER expandable spacer for the treatment of degenerative disc disease. Radiographic outcomes, intra-operative parameters, clinical outcomes, and patient satisfaction will be obtained from patients in this 2 year follow-up clinical study.

Description:

Patients will be followed-up at 3weeks, 6 weeks, 3 months, 6 months, 12 and 24 months with X-rays and questionnaires to determine their satisfaction, healing, fusion and return to work status

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: February 2017
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• DDD at 1 or 2 levels between L2 and S1

• Between 18 and 80 years of age

• Unresponsiveness to documented non-surgical treatment modalities for a minimum of six months

• Ability to provide a signed Informed Consent

Exclusion Criteria:

• Trauma at level(s) to be fused

• Previous documentation of osteopenia, osteoporosis, or osteomalacia to a degree that spinal instrumentation would be contraindicated

• Immunosuppressive disorder

• History of substance abuse

• Any known allergy to a metal alloy

Related Conditions & MeSH terms

• Degenerative Disc Disease
• Intervertebral Disc Degeneration

Intervention

Device:
• CALIBER
Expandable interbody spacer

Locations

Country	Name	City	State
United States	Carolina NeuroSurgery and Spine Associates	Charlotte	North Carolina
United States	South Florida Spine Institute at Mt Sinai Medical Center	Miami Beach	Florida

Sponsors (3)

Lead Sponsor	Collaborator
Globus Medical Inc	Carolina Neurosurgery & Spine Associates, Mt. Sinai Medical Center, Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fusion and Disc Height Maintenance	Inter-vertebral disc height in millimetres at 24 month follow up.	24 months
Primary	Fusion Assessment	An assessment of the fusion status of surgically treated spinal levels.	24 months
Secondary	Patient Self Assessment	Oswestry Disability Index. A 10 item questionnaire with responses scored 0 to 5 and then presented as a percentage score from 0 to 100, with higher scores denoting more disability.	Upto 24 mo
Secondary	Visual Analog Scale for Back Pain	A visual scale from 0 to 100 in which the patient responds with their pain level by marking on the line, higher as more severe pain.	24 months