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

• Conditions: Spinal Surgery

• Registration Number: NCT03501810
• Lead Sponsor: OrtoWay AB

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

Study Timeline

• Study First Submitted: 2018-03-12
• Status Verified: 2018-04
• Study Start: 2018-04-05
• Study First Submitted QC: 2018-04-17
• Last Update Submitted: 2018-04-17
• Study First Posted: 2018-04-18
• Last Update Posted: 2018-04-18
• Primary Completion: 2018-07-31
• Study Completion: 2018-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Device Reliability	During the procedure	Assessed by positioning accuracy,holding capability and ease of use

Secondary Outcome Measures

Name	Time	Method
Length of Procedure (hours)	During the procedure	Length of Procedure
Major complications	1 month	Major complications at 1 month
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
Re operation	1 month	Re operation at 1 month
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

Trial Locations

Locations (1)

Universitätsklinikum Bonn; 🇩🇪 Bonn, Germany