Sponsor-initiated, prospective, mono center observational trial for evaluation of the Favo® S-TLIF cage used in spine surgery according to the intended purpose
- Conditions
- M99.79M48.06M51.1M43.06M43.16M53.26M42.16M99.69Lumbar and other intervertebral disc disorders with radiculopathy
- Registration Number
- DRKS00027163
- Lead Sponsor
- Silony Medical GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 40
The ability to read, understand and speak the local language fluently to ensure understanding of informed consent and protocol-specific assessments.
The surgical indication must be one or a combination of the following
+ Degenerative disc diseases
+ Spondylolisthesis (up to grade 1)
+ Segmental instabilities
+ Spinal canal stenosis
+ Neuroforaminal stenosis
+ Intraforal herniated disc
+ 1-2 Level OPs (L1-S1)
+ Age: = 18 years
Absolute contraindications
+ Expected or documented allergy or intolerance to the materials (e.B. titanium)
+ Any case in which the chosen implants would be too large or too small, to achieve a successful result
+ Any patient in whom the use of the implant would conflict with anatomical structures
+ Lack of bony structures that make a good anchoring of the implants impossible (e.g. in fractures, tumors, osteoporosis or Infections).
Relative contraindications
+ patient's overweight (BMI > 35)
+ Fever or leukocytosis
+ Systemic diseases and metabolic disorders
+ One-sided diet, drug abuse, nicotine, alcohol or drug use
+ Physical activities associated with severe vibrations in which the implant is subjected to blows and/or excessive stress (e.B. heavy physical work, competitive sports, marathons, alpine skiing, jumping and team sports)
+ Patients who are mentally unable to understand and follow the doctor's instructions
+ Operations on pregnant women should be avoided as far as possible or require special care or procedures. This is at the discretion of the surgeon.
+ Any condition that could rule out the potential benefit of spinal implantation shall be clarified by the responsible physician. These can be: Tumors
+ A significant shift in the total blood count or other parameters.
+ The subject has anatomical or comorbid conditions or other medical, social or psychological conditions which, in the opinion of the investigator, increase the ability of the subject to participate in the clinical trial or to meet the follow-up requirements or affect the scientific soundness of the results of the clinical trial.
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Patient centered measurement of the functional status and the impairment of life quality measured by the Oswestry Disability Index (ODI) questionnaire preoperative compared to 12 months postoperative
- Secondary Outcome Measures
Name Time Method Assessment of the following clinical performance measurements: <br>-Global and segmental lordosis at the index segment <br>-Disc height/subsidence at the index segment<br><br>Optional: Segmental fusion after 12 months <br>Safety assessments: complications<br>Efficacy assessments: Pain reduction measured via VAS / pain scale (back- and leg/hip pain)