A study for confirming the functional effects of 3D-printed patient specific orthopedic fixation plates for patients with distal radius fractures or patients in need of corrective osteotomy

A prospective pivotal investigator clinical trial to confirm the functional effects of 3D-printed patient specific orthopedic fixation plates for patients with distal radius fractures or patients in need of corrective osteotomy

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0005932

Enrollment

Registered

2021-02-23

Start date

2021-03-19

Completion date

Unknown

Last updated

2025-07-21

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, Procedure/Surgery : Product the specific plate by taking an 3D-CT scan on appropriate part for the patient. In a distal radius fractures patient case, it is able to use 3D-printed pati

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) From 02.04.2021 to 05.31.2022, patients who visit Seoul asan medical center outpatient clinic or emergency room and with distal radius fractures or patients in need of corrective osteotomy 2) Patients aged over 19 to 70 years of age who have heard and understood the explanation of this study and consented in writing.

Exclusion criteria

Exclusion criteria: 1) Patients who had operation on same part 2) Patients who are susceptible to delayed recoveries due to some conditions, such as alcoholism or metabolic diseases. 3) Patients who are pregnant or lactating women. 4) Patients who are considered having difficulties to involve in this study by principal investigator

Design outcomes

Primary

Measure	Time frame
1) Recovery period to bone union (X-ray, CT scan);2) DASH and PRWE questionnaires;3) Wrist range of motion;4) Grip strenth	—

Secondary

Measure	Time frame
Demographical characteristics(ex. age, height, weight etc.);underlying conditions;medical history;dominant hand or not;pre-op blood test	—

Countries

Korea, Republic of

Contacts

Public ContactYoungho Shin

Asan Medical Center

123sinyh@gmail.com+82-2-3010-1838

Outcome results