Spinal Surgery
Conditions
Brief summary
Study to Assess the Safety and Performance of the OrtoWell® Distractor in Patients Undergoing Spinal Surgery
Detailed description
This is a Prospective, single-arm, multi-center, observational, post-market clinical follow-up study The OrtoWell® Distractor System (CE marked) is a device intended for separating and holding apart vertebral bodies in the spinal column, to facilitate removal of damaged discs, and implantation of disc prostheses or spinal cage prostheses, as well as for repositioning the vertebral bodies following implantation of disc or cage prostheses The OrtoWell® Distractor System will be used in patients undergoing anterior or lateral spinal surgery, where separation of vertebrae is required, including corpectomy, insertion of disc prosthesis, insertion of an anterior lumbar interbody fusion (ALIF) cage, and tumor surgery The study will enroll up to 32 patients in Germany that require one of the above listed intervention except the patients with a known osteoporosis Study subjects are expected to participate for approximately 30 days following the surgery. Participation will involve a screening period, surgery and scheduled follow-up assessment at 30 days post implant
Interventions
DEVICEDistractor use for vertebrae separation
Distractor use where separation of vertebrae is required, including corpectomy, insertion of disc prosthesis, insertion of an anterior lumbar interbody fusion (ALIF) cage, and tumor surgery
Sponsors
MedPass International
OrtoWay AB
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients undergoing spinal surgery, where use of the OrtoWell® Distractor System is indicated * Signed written informed consent
Exclusion criteria
* Pregnant patients at the time of spinal surgery * Known osteoporosis * BMI ≥ 30 * Obstacles to performing radioscopy (primarily lateral), such as obesity
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Device Reliability | During the procedure | Assessed by positioning accuracy,holding capability and ease of use |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major complications | Intra and peri operative periods | Evaluation of the major complications (cardiopulmonary, stroke, wound complications) |
| Hospital stay | Assessed at Discharge, approximately 3 days | Total duration of hospital stay assessed at Discharge |
| Minor complications | 1 month | Minor complications at 1 month |
| All cause mortality | 1 month | All cause mortality at 1 month |
| Length of Procedure (hours) | During the procedure | Length of Procedure |
| Re hospitalization | 1 month | Re hospitalization at 1 month |
| Device related SAE | 1 month | Device related SAE at 1 month |
| All AEs | 1 month | All AEs at 1 month |
| Re operation | 1 month | Re operation at 1 month |
Countries
Germany
Contacts
Primary ContactStan Mikulowski
Outcome results
None listed