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

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

Study Overview

• Status: Unknown
• Conditions: Spinal Surgery
• Intervention / Treatment: Device: Distractor use for vertebrae separation

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 Type: Observational
• Enrollment (Anticipated): 32

Contacts and Locations

• Study Contact: Name: Stan Mikulowski; Phone Number: 46 8 558 093 69; Email: stan.mikulowski@ortoway.com

Study Locations

• Germany
  • Bonn, Germany, 53127
    • Recruiting
    • Universitätsklinikum Bonn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device Reliability	Assessed by positioning accuracy,holding capability and ease of use	During the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of Procedure (hours)	Length of Procedure	During the procedure
Major complications	Evaluation of the major complications (cardiopulmonary, stroke, wound complications)	Intra and peri operative periods
Major complications	Major complications at 1 month	1 month
Hospital stay	Total duration of hospital stay assessed at Discharge	Assessed at Discharge, approximately 3 days
Minor complications	Minor complications at 1 month	1 month
All cause mortality	All cause mortality at 1 month	1 month
Re operation	Re operation at 1 month	1 month
Re hospitalization	Re hospitalization at 1 month	1 month
Device related SAE	Device related SAE at 1 month	1 month
All AEs	All AEs at 1 month	1 month

Collaborators and Investigators

• Sponsor: OrtoWay AB
• Collaborators: MedPass International
• Investigators: Principal Investigator: Robert Pflugmacher, Prof, University Hospital, Bonn

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 5, 2018
• Primary Completion (ANTICIPATED): July 31, 2018
• Study Completion (ANTICIPATED): September 30, 2018

Study Registration Dates

• First Submitted: March 12, 2018
• First Submitted That Met QC Criteria: April 17, 2018
• First Posted (ACTUAL): April 18, 2018

Study Record Updates

• Last Update Posted (ACTUAL): April 18, 2018
• Last Update Submitted That Met QC Criteria: April 17, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 01-2017

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes