A multicenter clinical trial pilot study of Radial head prosthesis fabricated by 3D printing technique
Phase 1
Recruiting
- Conditions
- Radial head fracture3d printingradial head prosthesis
- Registration Number
- TCTR20181008003
- Lead Sponsor
- Meticuly Company Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 10
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
Osteoarthritis of elbow
Patients with infection
Unconscious patient or Mental illness patients
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Complication 1st, 6th, 12th, 24th, 36th, and 48th weeks after surgery Elbow subluxation/dislocation, Stem loosening, Implant fracture, Infection, Hyp
- Secondary Outcome Measures
Name Time Method 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