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| Name | Class |
|---|---|
| Mt. Sinai Medical Center, Miami | OTHER |
| Carolina Neurosurgery & Spine Associates | OTHER |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CALIBER | Other | 1 or 2 levels of DDD between L2 and S1, treated with transforaminal interbody fusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CALIBER | Device | Expandable interbody spacer |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fusion and Disc Height Maintenance | Inter-vertebral disc height in millimetres at 24 month follow up. | 24 months |
| Fusion Assessment | An assessment of the fusion status of surgically treated spinal levels. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Upto 24 mo |
| Visual Analog Scale for Back Pain |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dan Cohen, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| South Florida Spine Institute at Mt Sinai Medical Center | Miami Beach | Florida | 33140 | United States | ||
The protocol was approved to enroll 60 patients but only 58 patients were enrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | CALIBER | 1 or 2 levels of Degenerative Disc Disease between L2 and S1, treated with transforaminal interbody fusion CALIBER: Expandable interbody spacer |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
Includes only those patients who completed the study
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| ID | Title | Description |
|---|---|---|
| BG000 | CALIBER | 1 or 2 levels of DDD between L2 and S1, treated with transforaminal interbody fusion CALIBER: Expandable interbody spacer |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Fusion and Disc Height Maintenance | Inter-vertebral disc height in millimetres at 24 month follow up. | 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. | Posted | Mean | Full Range | millimetres | 24 months | Surgical Levels | Surgical Levels |
|
|
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).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CALIBER | 1 or 2 levels of DDD between L2 and S1, treated with transforaminal interbody fusion CALIBER: Expandable interbody spacer |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brandon Bucklen | Globus Medical Inc. | 610-930-1800 | 2517 | bbucklen@globusmedical.com |
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| ID | Term |
|---|---|
| D055959 | Intervertebral Disc Degeneration |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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Lumbar interbody cages
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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. |
| 24 months |
| Carolina NeuroSurgery and Spine Associates |
| Charlotte |
| North Carolina |
| 28204 |
| United States |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Surgical Levels |
|
|
| Primary | Fusion Assessment | An assessment of the fusion status of surgically treated spinal levels. | Only 29 patients were available for fusion assessment at 24 months, for a total of 33 surgical levels. | Posted | Count of Units | Surgical Levels | 24 months | Surgical Levels | Surgical Levels |
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|
|
| Secondary | 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. | Not all patients completed the Oswestry Disability Index questionnaire at 24 month follow up, leaving 38 responses. | Posted | Mean | Full Range | scores on a scale | Upto 24 mo |
|
|
|
| Secondary | 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. | 38 patients completed the question at 24 month follow up | Posted | Mean | Full Range | score on a scale out of 100 | 24 months |
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| 0 |
| 43 |
| 0 |
| 43 |
| 0 |
| 43 |
PI may release for publication with Sponsor's prior approval.