Degenerative Disc Disease
Conditions
Brief 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.
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
Interventions
DEVICECALIBER
Expandable interbody spacer
Sponsors
Mt. Sinai Medical Center, Miami
Carolina Neurosurgery & Spine Associates
Globus Medical Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Lumbar interbody cages
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fusion and Disc Height Maintenance | 24 months | Inter-vertebral disc height in millimetres at 24 month follow up. |
| Fusion Assessment | 24 months | An assessment of the fusion status of surgically treated spinal levels. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Self Assessment | 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. |
| Visual Analog Scale for Back Pain | 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. |
Countries
United States
Participant flow
Pre-assignment details
The protocol was approved to enroll 60 patients but only 58 patients were enrolled.
Participants by arm
| Arm | Count |
|---|---|
| CALIBER 1 or 2 levels of DDD between L2 and S1, treated with transforaminal interbody fusion
CALIBER: Expandable interbody spacer | 43 |
| Total | 43 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 7 |
| Overall Study | Physician Decision | 3 |
| Overall Study | Withdrawal by Subject | 5 |
Baseline characteristics
| Characteristic | CALIBER |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 12 Participants |
| Age, Categorical Between 18 and 65 years | 31 Participants |
| Age, Continuous | 54 years |
| Region of Enrollment United States | 43 participants |
| Sex: Female, Male Female | 31 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 43 |
| other Total, other adverse events | 0 / 43 |
| serious Total, serious adverse events | 0 / 43 |
Outcome results
Primary
Fusion and Disc Height Maintenance
Inter-vertebral disc height in millimetres at 24 month follow up.
Time frame: 24 months
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| CALIBER | Fusion and Disc Height Maintenance | 11.60 millimetres |
Primary
Fusion Assessment
An assessment of the fusion status of surgically treated spinal levels.
Time frame: 24 months
Population: Only 29 patients were available for fusion assessment at 24 months, for a total of 33 surgical levels.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| CALIBER | Fusion Assessment | 33 Surgical Levels |
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.
Time frame: Upto 24 mo
Population: Not all patients completed the Oswestry Disability Index questionnaire at 24 month follow up, leaving 38 responses.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| CALIBER | Patient Self Assessment | 18.79 scores on a scale |
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.
Time frame: 24 months
Population: 38 patients completed the question at 24 month follow up
| Arm | Measure | Value (MEAN) |
|---|---|---|
| CALIBER | Visual Analog Scale for Back Pain | 10.71 score on a scale out of 100 |