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A prospective patient registry for bonegraft substitutes in spinal fusion

A prospective patient registry for bonegraft substitutes in spinal fusion - APPROACH-001-EU

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON36368
Enrollment
25
Registered
2011-06-21
Start date
2011-07-06
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients undergoing a spinal fusion surgery spinal surgery

Interventions

None listed

Sponsors

ApaTech Limited
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: requiring spinal fusion surgery failed conservative treatment >18 year

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
A patient profile for Actifuse and for other grafting products used to achieve bone fusion.

Secondary

MeasureTime frame
Overall successrate of the individual effectiveness endpoints, including improvement in outcomescales, neurologic improvement and radiographic fusion success.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)