Clinical trial NCT03501810: Study Assessing Safety and Performance of OrtoWell Distractor in Patients Undergoing Spinal Surgery
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Spinal Surgery
Lead sponsor: OrtoWay AB
Sponsor class: INDUSTRY
Collaborators: name: MedPass International
First posted: 2018-04-18
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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

Eligibility criteria: 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

Primary outcomes:
measure: Device Reliability
timeFrame: During the procedure
Secondary outcomes:
measure: Length of Procedure (hours)
timeFrame: During the procedure
measure: Major complications
timeFrame: Intra and peri operative periods
measure: Major complications
timeFrame: 1 month
measure: Hospital stay
timeFrame: Assessed at Discharge, approximately 3 days
measure: Minor complications
timeFrame: 1 month
measure: All cause mortality
timeFrame: 1 month
measure: Re operation
timeFrame: 1 month
measure: Re hospitalization
timeFrame: 1 month
measure: Device related SAE
timeFrame: 1 month
measure: All AEs
timeFrame: 1 month
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn
Study officials:
affiliation: University Hospital, Bonn
name: Robert Pflugmacher, Prof
role: PRINCIPAL_INVESTIGATOR
References: