Study of an Expandable Interbody Device for the Lumbar Spine

Not Applicable

Completed

• Conditions: Degenerative Disc Disease
• Interventions: Device: CALIBER

• Registration Number: NCT02075554
• Lead Sponsor: Globus Medical Inc

Brief 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.

Detailed 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

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2014-02-04
• Study First Submitted QC: 2014-02-27
• Study First Posted: 2014-03-03
• Primary Completion: 2016-11
• Study Completion: 2017-02
• Results First Submitted: 2020-08-25
• Status Verified: 2021-02
• Results First Submitted QC: 2021-02-02
• Last Update Submitted: 2021-02-02
• Results First Posted: 2021-02-03
• Last Update Posted: 2021-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CALIBER	CALIBER	1 or 2 levels of DDD between L2 and S1, treated with transforaminal interbody fusion

Primary Outcome Measures

Name	Time	Method
Fusion and Disc Height Maintenance	24 months	Inter-vertebral disc height in millimetres at 24 month follow up.
Fusion Assessment	24 months	An assessment of the fusion status of surgically treated spinal levels.

Secondary Outcome Measures

Name	Time	Method
Patient Self Assessment	Upto 24 mo	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.
Visual Analog Scale for Back Pain	24 months	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.

Trial Locations

Locations (2)

Carolina NeuroSurgery and Spine Associates; 🇺🇸 Charlotte, North Carolina, United States

South Florida Spine Institute at Mt Sinai Medical Center; 🇺🇸 Miami Beach, Florida, United States