Degenerative Cervical Disc Disease, Degenerative Lumbar Diseases
Conditions
Brief summary
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.
Interventions
Standard Anterior Cervical Interbody Fusion with Stand-alone Cervical Cages
Standard Anterior Lumbar Interbody Fusion with Stand-Alone Lumbar Cages
Standard Lateral Lumbar Interbody Fusion with Stand-alone Lumbar cage
Sponsors
Silony Medical GmbH
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- Indications according to IFU Surgical implantation of STALIF® C or M FLX device for 1 or 2 levels between: * STALIF® C FLX: C2-T1 (cervical) * STALIF® M FLX: L2-S1 (lumbar) * STALIF® L FLX: L2-L5 (lumbar) Surgical implantation of FORTOS-C® for the fusion of up to 3 levels between: * FORTOS-C®: C2 - T1 (cervical) * Age: ≥ 21 years * For the evaluation of the questionnaires (NDI or ODI, VAS neck and VAS arm or VAS leg and VAS back), only patients with the questionnaire available at the time of admission (pre-op) and at least at 12-months FU will be included
Exclusion criteria
* Relative and absolute contraindications according to IFU
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neck Disability Index | Baseline, 3 months postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative | 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%). |
| Oswestry Disability Index | Baseline, 3 months postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Scale | Baseline, 3 months postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative | The Visual Analogue Scale (VAS) is usually quantified from 0 to 10, where 0 means 'no pain' and 10 means 'strongest pain imaginable'. |
| Radiological assessment | Baseline, 3 months postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative | * Implant migration/ Subsidence/ Screw Back-out * Bone Fusion at latest follow-up |
| Complications | Baseline, 3 months postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative | Intraoperative and postoperative complications, revisions, and (serious) adverse events |
Countries
United States
Outcome results
None listed