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A multicenter clinical trial pilot study of Radial head prosthesis fabricated by 3D printing technique

A multicenter clinical trial pilot study of Radial head prosthesis fabricated by 3D printing technique

Status
Recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20181008003
Enrollment
10
Registered
2018-10-08
Start date
2018-10-06
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Radial head fracture Radial head fracture 3d printing radial head prosthesis

Interventions

Radial head prosthesis fabricated by 3D printing technique design by the normal radial head from contralateral side made by Rematitan® CL&#44
Ti90 Al6 V4&#44
using Selective Laser Melting technique and Autoclave
Experimental Procedure/Surgery
Radial head prosthesis fabricated by 3D printing technique

Sponsors

Meticuly Company Limited
Lead Sponsor
Meticuly Company Limited
Collaborator

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Age 18-80 years old Radial head fracture Mason type III-IV Radial head tumor not beyond 8 cm from radial head Normal opposite radial head with no history of surgery or fracture Willing to join the research

Exclusion criteria

Exclusion criteria: Osteoarthritis of elbow Patients with infection Unconscious patient or Mental illness patients

Design outcomes

Primary

MeasureTime frame
Complication 1st, 6th, 12th, 24th, 36th, and 48th weeks after surgery Elbow subluxation/dislocation, Stem loosening, Implant fracture, Infection, Hyp

Secondary

MeasureTime frame
Function 1st, 6th, 12th, 24th, 36th, and 48th weeks after surgery DASH score, Mayo Elbow Performance Score, Pain Visual Analog Scale, Range of Motion, Congruity of th

Countries

Thailand

Contacts

Public ContactChris Charoenlap

Faculty of Medicine, Chulalongkorn University

chris.cha@chula.ac.th081-4819209

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026