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Performance of Inductigraft in Spinal Fusion

NCT01452022 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2017-04-05

No results posted yet for this study

Summary

This is an open-label non-randomised, prospective, post market study to evaluate the performance of Inductigraft (osteoinductive synthetic bone graft) in patients receiving posterolateral lumbar spine fusion through assessment of successful fusion at 12 months post operation using x-rays and CT scans. Quality of life questionnaires also used to assess clinical outcome measures such as pain and quality of life. Patients followed up for 24 months after surgery.

Conditions

  • Degenerative Disk Disease
  • Spinal Stenosis of Lumbar Region

Interventions

DEVICE

Inductigraft

Synthetic bone graft

Sponsors & Collaborators

  • Apatech, Inc.

    collaborator INDUSTRY

  • Baxter Healthcare Corporation

    lead INDUSTRY

Principal Investigators

  • Ciaran Bolger · Beaumont Hospital, Dublin

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2015-08-31
Completion
2015-08-31

Countries

  • Germany
  • Hungary
  • Ireland
  • Spain
  • United Kingdom

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 NCT01452022 on ClinicalTrials.gov