Study of an Expandable Interbody Device for the Lumbar Spine

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2017-02-28

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Degenerative Disc Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Lumbar interbody cages

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CALIBER

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

Group Type OTHER

CALIBER

Intervention Type DEVICE

Expandable interbody spacer

Interventions

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CALIBER

Expandable interbody spacer

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No