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Spinal system multicenter RCT study for Idiopathic Scoliosis

Spinal system multicenter RCT study for Idiopathic Scoliosis - Deformity study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000008838
Enrollment
80
Registered
2012-09-07
Start date
2012-07-24
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Idiopathic Scoliosis

Interventions

Titanium Alloy group Vitallium group

Sponsors

Stryker Japan
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Patient who have an Idiopathic Scoliosis. 2. Patient whose pre-operative Cobb angle is greater than 45 degrees. 3. Lenke type 1, 2 and 3. 4. Patient whose age is between 10 and 19 years age. 5. Female. 6. Ability to read and understand Japanese. 7. Patient and legally authorized representative can provide voluntary informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients who have abnormal bone remodeling. 2. Patients who had previous spine surgery and second surgery. 3. Patients who are pregnant or potential pregnancy. 4. Patients who have Infection related disease. 5. Patients who have non healing open wounds. 6. Patients who have serious metal allergy related diseases. 7. Patients who has a diagnosed neuromuscular deficit.

Design outcomes

Primary

MeasureTime frame
The correction rate of Cobb angle after surgery

Countries

Japan

Contacts

Public Contactyuko.komori

Stryker Japan Clinical affairs

yuko.komori@stryker.com03-6894-8322

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026