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Completed

NCT Number: NCT02075554

Study of an Expandable Interbody Device for the Lumbar Spine

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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Key information

Conditions

Degenerative Disc Disease Bone Diseases Intervertebral Disc Degeneration Musculoskeletal Diseases Spinal Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CALIBER

Device

Expandable interbody spacer

Primary outcomes

  1. Fusion and Disc Height Maintenance

    Time frame: 24 months

    Inter-vertebral disc height in millimetres at 24 month follow up.

  2. Fusion Assessment

    Time frame: 24 months

    An assessment of the fusion status of surgically treated spinal levels.

Secondary outcomes

  1. Patient Self Assessment

    Time frame: 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.

  2. Visual Analog Scale for Back Pain

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Globus Medical Inc

Industry

Collaborators

  • Carolina Neurosurgery & Spine Associates
  • Mt. Sinai Medical Center, Miami

Registry information

Official study title

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

Acronym: CALIBER

Important dates

Study start
2012
Primary completion
2016
Study completion
2017
First posted
Mar 3, 2014
Registry last updated
Feb 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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