M51 M43
Conditions
Interventions
Group 1: Patients with damage or diseases of the musculoskeletal system requiring surgery for which a ROCCIA MultiLIF (as ALIF) or ROCCIA ALIF may be considered.
Sponsors
Silony Medical GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: ? The surgical indication must be one or a combination of the following o Indications according to IFU - Degenerative disc diseases - Deformities - Segmental dysfunctions of the lumbar or thoracolumbar spine - Spondylolistheses - Segmental instabilities - Stenoses ? Mono-, bi- und multisegmental instrumentation ? Age: = 18 years ? Surgical technique: ROCCIA MultiLIF® ALIF cage system or ROCCIA® ALIF cage system used with additional stabilization ? Patients for prospective part of the PMCF study must provide written informed consent prior to any action related to the PMCF study
Exclusion criteria
Exclusion criteria: Relative and absolute contraindications according to IFU Absolute contraindications - Expected or documented allergy or intolerance to the materials (e.g. 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 the anatomical structures. - Missing bony structures that make good anchorage of the implant impossible (e.g. fractures, tumours, osteoporosis or infections.) Relative contraindications - Overweight of the patient - Malformations - Fever or leukocytosis - Systemic diseases and metabolic disorders - Unbalanced diet, drug abuse, nicotine, alcohol, drug use - Physical activities involving severe shocks and/or excessive stress on the implant (e.g. heavy physical work, competitive sports, marathons, alpine skiing, jumping and team sports). - Patient who is mentally incapable of understanding and following the doctor's instructions. - Operations on pregnant women should be avoided if possible or require special care or procedure. This is at the discretion of the surgeon. Any condition that could preclude the potential benefit of spinal implantation must be clarified by the applying physician. These could be: tumours, local fractures in the area of the surgical site, unexplained elevation of the erythrocyte sedimentation rate due to other diseases, elevation of leukocytes or a significant shift in the differential blood count or other parameters.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of clinical benefit: Comparison of Oswestry Disability Index (ODI) pre-OP with 4-months and 12-months FU | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of clinical safety and performance: ? Radiology assessment o Implant migration o Restoration of intervertebral height/physiological lordosis o Fusion ? Neurological assessment ? Complications/risks (intraoperative and postoperative complications, revisions, (serious) incidents and (serious) adverse events) Evaluation of clinical benefit: ? Comparison of VAS leg and VAS back pre-OP with 4 months and 12-months FU | — |
Countries
Germany
Contacts
Public ContactRoland Rusz
Wirbelsäulenzentrum Schön Klinik Bad Aibling SE & Co. KG
Outcome results
None listed