Clinical trial on the effect of difference in surgical procedure for treating adult spinal deformity

Clinical trial on the effect of difference in surgical procedure for treating adult spinal deformity - Clinical trial on the effect of difference in surgical procedure for treating adult spinal deformity

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000033082

Enrollment

Registered

2018-07-01

Start date

2017-05-01

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

Adult spinal deformity

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Subjects who are diagnosed as adult spinal deformity and are an applicable to lumber interbody fusion. 2. Subjects who fall under any of Cobb angle more than 20 degrees, PT 20 degree, SVA 50mm, or TPA 20 degrees on pre-operation. 3. Upper instrumented vertebra is above L2, and any one of S2AI screw, iliac screw or LSIT can be used on lower instrumented vertebra. 4. Subjects over 45 year of age. 5. Subjects capable of reading and understanding Japanese. 6. Subject who can provide voluntary informed consent.

Exclusion criteria

Exclusion criteria: 1. Subjects who have had spinal fixation. 2. Subjects who are pregnant or will be possibly pregnant. 3. Subjects who have an allergy to nickel, chromium, or Titanium alloy. 4. Subjects who have an actively spinal infection. 5. Subjects who are an inappropriate for participating in the study in the judgement of the investigator.

Design outcomes

Primary

Measure	Time frame
Radiographic outcomes and QOL improvement rate at the 24 months follow-up	—

Countries

Japan

Contacts

Public ContactYuko Komori

Stryker Japan K.K. Clinical Affairs

NSKclinicaltrial@stryker.com03-6894-8394

Outcome results