Degenerative Disc DiseaseCALIBERNCT02075554

Study of an Expandable Interbody Device for the Lumbar Spine

A study testing CALIBER in people with Degenerative Disc Disease, run by Globus Medical Inc at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Degenerative Disc Disease
What is being tested?: CALIBER
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 58 participants
Where: 2 sitesUnited States
Study dates: Jul 2012to Feb 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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 locations and contacts

2 sites in 1 country.

United States2 sites

Carolina NeuroSurgery and Spine Associates
Charlotte, North Carolina, 28204
South Florida Spine Institute at Mt Sinai Medical Center
Miami Beach, Florida, 33140

Other trials in United States

About this study

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

Read the 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

Conditions: Degenerative Disc Disease
Being tested: CALIBER
Medical subject headings: Intervertebral Disc Degeneration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CALIBERDevice
Expandable interbody spacer

Study groups in NCT02075554
Study group	Role	What they receive
CALIBER	Other	1 or 2 levels of DDD between L2 and S1, treated with transforaminal interbody fusion Receives: Device: CALIBER

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (2)

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.
Measured: Upto 24 mo
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.
Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2012Feb 2017

First posted3 Mar 2014 (estimated)
Study startJul 2012
Primary completionNov 2016
Study completionFeb 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Degenerative Disc DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: Lumbar interbody cages
Masking: None (open label)
Enrolment: 58 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02075554
Sponsor's protocol ID: RGC10-009-001-PL_H_2
Acronym: CALIBER
Status last verified: Feb 2021
First submitted: 4 Feb 2014
Last updated: 3 Feb 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
CANLINK: Evaluation of the Intralink Intradiscal Device for Low Back Pain Due to Degenerative Disc Disease
Degenerative Disc Disease(DDD)
Active, not recruiting
Post Marketing Study of MagnetOs Easypack Putty Standalone Compared to Demineralized Bone Matrix or Fibers Mixed With Autograft in Patients Undergoing Posterolateral Lumbar Fusion
Degenerative Disc Disease, Spine Fusion
Not yet recruitingObservational study
Relationship Between Disability, Flexibility, Back Muscles, and Thoracolumbar Fascia in Patients With Lumbar Disc Degeneration
Intervertebral Disc Degeneration
Active, not recruiting
ASCEND: A Clinical Trial to Evaluate the Safety and Effectiveness of VIA Disc NP, a Supplement for Degenerated Intervertebral Discs
Degenerative Disc Disease, Disc Degeneration
Active, not recruiting
The Synergy Disc for the Treatment of 2 Level Cervical Degenerative Disc Disease Compared With Cervical Fusion Surgery
Cervical Degenerative Disc Disease

All Degenerative Disc Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02075554
Acronym / sponsor ID: CALIBER / RGC10-009-001-PL_H_2
Conditions: Degenerative Disc Disease
Study type: Interventional
Recruitment status: Completed
Enrolment: 58 participants (actual)
Lead sponsor: Globus Medical IncIndustry (pharma, biotech, devices)
Collaborators: Mt. Sinai Medical Center, Miami, Carolina Neurosurgery & Spine Associates
Study start: Jul 2012
Primary completion: Nov 2016 (actual)
Study completion: Feb 2017 (actual)
First posted: 3 Mar 2014 (estimated)
Results: Posted 3 Feb 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Lumbar interbody cages

Arm	Type	Receives
CALIBER	Other	Device: CALIBER1 or 2 levels of DDD between L2 and S1, treated with transforaminal interbody fusion

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CALIBERExpandable interbody spacer	Device	CALIBER

Primary outcome

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

2 secondary outcomes

Patient Self Assessment
Time frame: Upto 24 mo
Visual Analog Scale for Back Pain
Time frame: 24 months

Results and safety

Results posted to the registry on 3 Feb 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CALIBER	58	43

Primary outcome: Fusion and Disc Height Maintenance

Time frame: 24 months. Mean (Full Range). Unit: millimetres

Measure	CALIBER n = 29
Value	11.60 (8.62 to 15.60)

Population analysed: Not all patients had x ray images to measure at 24 month follow up. A total of 33 surgical levels were measured from 29 patients.

Primary outcome: Fusion Assessment

Time frame: 24 months. Count of units. Unit: Surgical Levels

Measure	CALIBER n = 29
Value	33

Population analysed: Only 29 patients were available for fusion assessment at 24 months, for a total of 33 surgical levels.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Subjects were assessed for adverse events by their physician over 24 months postoperative time period at each follow up point (Intraoperatively, 6 weeks, 3 months, 6 months, 12 months and 24 months postoperatively).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CALIBER	0 of 43 (0%)	0 of 43 (0%)	0 of 43

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Degenerative Disc Disease

Not yet recruiting
CANLINK: Evaluation of the Intralink Intradiscal Device for Low Back Pain Due to Degenerative Disc Disease
Degenerative Disc Disease(DDD)
Active, not recruiting
Post Marketing Study of MagnetOs Easypack Putty Standalone Compared to Demineralized Bone Matrix or Fibers Mixed With Autograft in Patients Undergoing Posterolateral Lumbar Fusion
Degenerative Disc Disease, Spine Fusion
Not yet recruitingObservational study
Relationship Between Disability, Flexibility, Back Muscles, and Thoracolumbar Fascia in Patients With Lumbar Disc Degeneration
Intervertebral Disc Degeneration
Active, not recruiting
ASCEND: A Clinical Trial to Evaluate the Safety and Effectiveness of VIA Disc NP, a Supplement for Degenerated Intervertebral Discs
Degenerative Disc Disease, Disc Degeneration
Active, not recruiting
The Synergy Disc for the Treatment of 2 Level Cervical Degenerative Disc Disease Compared With Cervical Fusion Surgery
Cervical Degenerative Disc Disease

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Dan Cohen, MD principal investigator

Icahn School of Medicine at Mount Sinai

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing CALIBER in people with Degenerative Disc Disease, run by Globus Medical Inc at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fusion and Disc Height Maintenance (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02075554.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2021.