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RCT of AttraX® Putty vs. Autograft in Instrumented Posterolateral Spinal Fusion

NCT01982045 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2019-02-05

No results posted yet for this study

Summary

The purpose of this study is to demonstrate the non-inferiority of AttraX® Putty as a bone graft substitute for autograft in instrumented posterolateral fusion of the thoracolumbar spine, in terms of efficacy and safety.

Conditions

  • Spinal Deformity
  • Spinal Instability
  • Instrumented Spinal Fusion

Interventions

DEVICE

AttraX® Putty

Synthetic bone graft comprised of calcium phosphate granules and hydroxyapatite with an advanced biodissolvable polymer carrier that allows for better handling of the granules in putty form.

OTHER

Autologous bone graft

Corticocancellous bone harvested from the iliac crest, with our without local bone obtained from decompression and/or preparation for fusion (facetectomy and denudement).

Sponsors & Collaborators

  • NuVasive

    collaborator INDUSTRY

  • UMC Utrecht

    lead OTHER

Principal Investigators

  • Moyo Kruyt, MD, PhD · UMC Utrecht

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2017-07-31
Completion
2018-08-31

Countries

  • Netherlands

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 NCT01982045 on ClinicalTrials.gov