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A prospective randomized controlled pivotal clinical trial to confirm the safety and efficacy of special coating of orthopedic fixation plate for patients with distal radius fracture

A prospective randomized controlled pivotal clinical trial to confirm the safety and efficacy of special coating of orthopedic fixation plate for patients with distal radius fracture

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CRIS
Registry ID
KCT0009252
Enrollment
58
Registered
2024-03-15
Start date
2024-07-01
Completion date
Unknown
Last updated
2024-07-23

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 : Produce 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 LOIS coated 3D-printed patient spe

Sponsors

Asan Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patient who visits Seoul Asan Medical Center orthopedic outpatient clinic or emergency room and is in need of open reduction and internal fixation 2) Patient who agrees to participate in this study and whose age is between 19 and 80

Exclusion criteria

Exclusion criteria: 1) Patient who had surgical treatment on the same side 2) Patient who is alcoholic or patient who has metabolic disease or physical condition that can delay the union of bones 3) Patient who is infected actively or latently 4) Patient who is sensitive to implants 5) Patient who is in a septic condition or has sepsis 6) Patient who is pregnant or is a lactating woman 7) Patient who is judged to be not adequate to participate in this study 8) Patient who refuses to participate in this study (patient who does not or cannot follow post-operation instructions) 9) Patient whose infection site is wide or has active chronic infection or is HIV host

Design outcomes

Primary

MeasureTime frame
RUSS (Radius Union Scoring System) score;Delayed fracture union ;Wrist range of motion;WBC, CRP, ESR;Duration of antibiotics usage;Incidence of breakage of the plate and screws;pain VAS (Visualized Analog Scale) score;DASH (Disability of the Arm, Shoulder and Hand) score;Patient-Rated Wrist Evaluation (PRWE) score

Secondary

MeasureTime frame
Demographical characteristics(ex. age, height, weight etc.);underlying diseases;dominant hand or not;Incidence of adverse event

Countries

Korea, Republic of

Contacts

Public ContactByung Hun Oh

Asan Medical Center

obhqkenr@naver.com+82-2-3010-4018

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026