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Post-operative clinical outcome data on the devices used to treat spinal diseases are collected and evaluated in order to analyze the safety and performance of the implants used.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FORTOS-C | Patients treated with FORTOS-C |
| |
| STALIF C FLX | Patients treated with STALIF C FLX |
| |
| STALIF M FLX | Patients treated with STALIF M FLX |
| |
| STALIF L FLX | Patients treated with STALIF L FLX |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anterior Cervical Interbody Fusion | Device | Standard Anterior Cervical Interbody Fusion with Stand-alone Cervical Cages |
|
| Measure | Description | Time Frame |
|---|---|---|
| Neck Disability Index | The Neck Disability Index (NDI) has 10 items that cover various aspects of daily functioning, such as pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation. Scoring: Each question contains six answer choices, scored from 0 (no disability) to 5 (complete disability). All section scores are then totaled. Scoring is reported on a 0-50 scale, 0 being the best possible score and 50 being the worst. Alternately, the score can be reported from 0-100. The score is often reported as a percentage (0-100%). | Baseline, 3 months postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative |
| Oswestry Disability Index | The Oswestry Disability Index (ODI) is used to measure the extent of pain-related functional limitations in people with low back pain. The questionnaire provides the user with information about the general functional ability of a patient with low back pain in everyday life. Six response options are available for the following items: pain intensity, self-care (washing, dressing), lifting, locomotion, sitting or standing, sleeping, sex life, social life and travel/transportation. The first answer option (score 0) means that there are no pain-related restrictions, while the sixth answer option (score 5) indicates the greatest perceived restriction of an activity due to pain. | Baseline, 3 months postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogue Scale | The Visual Analogue Scale (VAS) is usually quantified from 0 to 10, where 0 means 'no pain' and 10 means 'strongest pain imaginable'. | Baseline, 3 months postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative |
| Radiological assessment |
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Inclusion Criteria:
- Indications according to IFU
Surgical implantation of STALIF® C or M FLX device for 1 or 2 levels between:
Surgical implantation of FORTOS-C® for the fusion of up to 3 levels between:
Exclusion Criteria:
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Patient population is defined by Inclusion and exclusion criteria.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Golden State Orthopedics and Spine | San Ramon | California | 94583 | United States |
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| Anterior lumbar Interbody Fusion | Device | Standard Anterior Lumbar Interbody Fusion with Stand-Alone Lumbar Cages |
|
| Lateral Lumbar Interbody Fusion | Device | Standard Lateral Lumbar Interbody Fusion with Stand-alone Lumbar cage |
|
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| Baseline, 3 months postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative |
| Complications | Intraoperative and postoperative complications, revisions, and (serious) adverse events | Baseline, 3 months postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative |