Study of an Expandable Interbody Device for the Lumbar Spine (CALIBER)

Globus Medical

Status: Completed

Conditions: Degenerative Disc Disease

Treatments: Device: CALIBER

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02075554

RGC10-009-001-PL_H_2

Details and patient eligibility

About

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.

Full 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

Enrollment: 58 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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58 participants in 1 patient group

CALIBER

Other group

Description:

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

Treatment:

Device: CALIBER