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

OrtoWay

Status: Unknown

Conditions: Spinal Surgery

Treatments: Device: Distractor use for vertebrae separation

Study type: Observational

Funder types: Industry

Identifiers

NCT03501810

01-2017

Details and patient eligibility

About

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

Full 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

Enrollment: 32 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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