NCT03501810

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 32 (estimated)
• Sponsor: OrtoWay AB · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Conditions

• Spinal Surgery

Interventions

Type	Name	Description
DEVICE	Distractor 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

Timeline

• Start date: 2018-04-05
• Primary completion: 2018-07-31
• Completion: 2018-09-30
• First posted: 2018-04-18
• Last updated: 2018-04-18

Locations

1 site across 1 country: Germany

Regulatory

• FDA-regulated device study