Thoracolumbar corpectomy and stabilization with the icotec KONG®_TL VBR E: A post-market non-interventional clinical investigation in trauma and tumor patients

Recruiting

Conditions: trauma or tumor damaged vertebral body in the thoracic or lumbar spine

Registration Number: DRKS00026213

Lead Sponsor: icotec ag

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 71

Inclusion Criteria

Patient has a fractured vertebral body due to trauma or a pathologic situation / fracture due to tumorous or metastatic diseases of the spine
- Vertebral body has to be resected for treatment.
- Resected level is between T1 and L5, both included.
- 1-2 levels (contiguous) to be resected
- Patient is eligible for stabilization with KONG®-TL VBR E in conjunction with supplemental spinal fixation with a posterior pedicle screw and rod system (as listed in the IFU)
- Patient is at least 18 years old
- Patient is willing to participate in the postoperative follow-up program and has provided written informed consent
- ASIA D or E (for trauma patients)

Exclusion Criteria

- Patient has a contraindication to surgery or to any implant systems used in the study (as listed in the IFU).
- Pre-existing spinal stabilizations in the adjacent segment to the vertebra to be replaced (exception: two-stage surgery)
- Any kind of psychiatric disorder or condition not allowing to consent for the study
- Known chronic drug/alcohol abuse
- Inability to follow the procedures of the study
- Vulnerable patients

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Stability of the motion segment (bisegmental kyphotic angle (BKA)) measured as radiographic parameter at 24 months compared to baseline (0-8 days postop). The assessment is done based on x-rays by the indepentent central data assessment.

Secondary Outcome Measures

Name	Time	Method
The following secondary performance outcomes will be analyzed (descriptive only):<br><br>- Responder rate: proportion of patients achieving a BKA change of <5° between 0-8d and 24m post-operative<br>- BKA at the perioperative and each postoperative visit<br>- PROST score (for trauma patients only)<br>- Karnofsky-Index (KPSS) (for tumor patients only)<br>- Post-operative COMI<br>- NRS pain<br>- Segmental height<br>- VBR collapse absolute values<br>- VBR collapse preservation of values over time<br>- Fusion rate based on 12 months CT<br><br>The following secondary safety outcomes will be analyzed:<br>- Device subsidence<br>- Device migration<br>- Description of Serious Adverse Device Effects (SADEs)