Clinical results of cement-augmented pedicle screw fixation in patients with osteoporosis

Analysis of clinical stability and efficacy of cement-augmented pedicle screw fixation in patients with osteoporosis

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0005997

Enrollment

Registered

2021-03-12

Start date

2021-03-19

Completion date

Unknown

Last updated

2021-08-30

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

Conditions

None listed

Interventions

Medical Device : This study is to exploratively identify the efficacy of a distal one-hole fenestrated screw compared to the conventional fenestrated screw. A total of 70 patients will be recruited, e

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients over 20 years of age who are scheduled to perform posterior spinal instrumentation due to a thoracolumbar fracture or degenerative disease. 2) Patients with osteoporosis (T score = -2.5) on the bone mineral density test. 3) Patients judged by a surgeon that cement augmentation is necessary to obtain sufficient fixation of pedicle screws during surgery. 4) Patients who voluntarily agree to participate in this clinical trial

Exclusion criteria

Exclusion criteria: 1) Patients undergoing spinal surgery for infection or spinal cord tumor. 2) Patients who undergoing interbody fusion 3) Patients judged unsuitable for participation in clinical trials by investigators

Design outcomes

Primary

Measure	Time frame
Postoperative complication;screw loosening;fusion rate	—

Secondary

Measure	Time frame
Distribution pattern of bone cement;Oswestry Disability Index (ODI) score	—

Countries

Korea, Republic of

Contacts

Public ContactJiwon Kwon

Yonsei University Health System, Gangnam Severance Hospital

kwonjjanng@yuhs.ac+82-31-900-3114

Outcome results