Pilot study on effectiveness and safety of Shape Memory Scoliosis Correction Instrument

Pilot study on effectiveness and safety of Shape Memory Scoliosis Correction Instrument - Scoliosis Correction Instrument

Status

Active, not recruiting

Phases

Phase 2

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON36472

Enrollment

Registered

2011-03-16

Start date

2011-06-01

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

scoliosis

Interventions

None listed

Eligibility

Age

12 Years to 99 Years

Inclusion criteria

Inclusion criteria: Adolescents between 13 and 25 year suffering from idiopathic scolioses and listed for surgical intervention.4.2 Inclusion criteria • Cobb Angle > 40* • King I-V

Exclusion criteria

Exclusion criteria: Exclusion criteria • Severe scoliosis, very stiff spine (minimal correction on bending films) • Reduced bone quality (osteoporosis, decalcification) • Fractures • Tumors • Spondylolistheses • Active infection • Allergy to Titanium or it*s alloys

Design outcomes

Primary

Measure	Time frame
Study parameters/endpoints Main study parameter/endpoint • De-rotation measured at the middle two vertebra connected to the instrument should be > 50% during surgery. • Post-surgery Rib Hump reduction should be > 20%	—

Countries

Netherlands

Outcome results