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

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

Detailed Description
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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

Official Title
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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

Conditions
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Spinal Surgery

Intervention / Treatment
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* Device: Distractor use for vertebrae separation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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|

What is the study measuring?
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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 |