MedPath

A prospective patient registry for bonegraft substitutes in spinal fusio

Phase 4
Recruiting
Conditions
Patients undergoing a spinal fusion surgery
spinal surgery
10010761
10005944
Registration Number
NL-OMON36368
Lead Sponsor
ApaTech Limited
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
25
Inclusion Criteria

requiring spinal fusion surgery
failed conservative treatment
>18 year

Exclusion Criteria

Systemic infection or infection op the surgical site
Poor general health
Substance abuse
Pregnancy
participation in another trial

Study & Design

Study Type
Observational invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>A patient profile for Actifuse and for other grafting products used to achieve<br /><br>bone fusion.</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>Overall successrate of the individual effectiveness endpoints, including<br /><br>improvement in outcomescales, neurologic improvement and radiographic fusion<br /><br>success.</p><br>
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