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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

32 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-05

Study Completion Date

2018-09-30

Brief Summary

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

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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

Conditions

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Spinal Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No