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 Details — Status: Recruiting

Administrative data

• NCT number: NCT03501810
• Other study ID #: 01-2017
• Status: Recruiting
• First received: March 12, 2018
• Last updated: April 17, 2018
• Start date: April 5, 2018
• Est. completion date: September 30, 2018

Study information

• Verified date: April 2018
• Source: OrtoWay AB
• Contact: Stan Mikulowski
• Phone: 46 8 558 093 69
• Email: stan.mikulowski[@]ortoway.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: September 30, 2018
• Est. primary completion date: July 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Spinal Surgery

Intervention

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

Locations

Country	Name	City	State
Germany	Universitätsklinikum Bonn	Bonn

Sponsors (2)

Lead Sponsor	Collaborator
OrtoWay AB	MedPass International

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Device Reliability	Assessed by positioning accuracy,holding capability and ease of use	During the procedure
Secondary	Length of Procedure (hours)	Length of Procedure	During the procedure
Secondary	Major complications	Evaluation of the major complications (cardiopulmonary, stroke, wound complications)	Intra and peri operative periods
Secondary	Major complications	Major complications at 1 month	1 month
Secondary	Hospital stay	Total duration of hospital stay assessed at Discharge	Assessed at Discharge, approximately 3 days
Secondary	Minor complications	Minor complications at 1 month	1 month
Secondary	All cause mortality	All cause mortality at 1 month	1 month
Secondary	Re operation	Re operation at 1 month	1 month
Secondary	Re hospitalization	Re hospitalization at 1 month	1 month
Secondary	Device related SAE	Device related SAE at 1 month	1 month
Secondary	All AEs	All AEs at 1 month	1 month