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Study Assessing Safety and Performance of OrtoWell Distractor in Patients Undergoing Spinal Surgery

Spinal Surgery Clinical Trial

Official title:
Prospective, Single-Arm, Post-Market Clinical Follow-up (PMCF) Study to Further Assess the Safety and Performance of the OrtoWell® Distractor in Patients Undergoing Spinal Surgery

Clinical Trial Summary

Study to Assess the Safety and Performance of the OrtoWell® Distractor in Patients Undergoing Spinal Surgery

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03501810
Study type Observational
Source OrtoWay AB
Contact Stan Mikulowski
Phone 46 8 558 093 69
Email stan.mikulowski@ortoway.com
Status Recruiting
Phase
Start date April 5, 2018
Completion date September 30, 2018
View Details
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