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

NCT03501810 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 32

Last updated 2018-04-18

No results posted yet for this study

Summary

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

Conditions

  • Spinal Surgery

Interventions

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

Sponsors & Collaborators

  • MedPass International

    collaborator INDUSTRY

  • OrtoWay AB

    lead INDUSTRY

Principal Investigators

  • Robert Pflugmacher, Prof · University Hospital, Bonn

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-05
Primary Completion
2018-07-31
Completion
2018-09-30
FDA Device
Yes

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03501810 on ClinicalTrials.gov