A prospective, randomised multicenter controlled trial on the treatment of intra-articular distal radius fractures; open reduction and internal fixation with volair angle stable plating versus percutaneous reduction and fixation in combination with an external fixator

A prospective, randomised multicenter controlled trial on the treatment of intra-articular distal radius fractures; open reduction and internal fixation with volair angle stable plating versus percutaneous reduction and fixation in combination with an external fixator - MiniMax Study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON31202

Enrollment

148

Registered

2007-09-06

Start date

2008-02-01

Completion date

Unknown

Last updated

2024-07-22

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

Conditions

wrist fracture

Interventions

Group A will get a treatment with ORIF (open reposition and internal fixation) and group B will get an external fixation

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: age > 50 informed consent dutch language intra-articular fractures type AO B/C and Frykmann III, IV, VII and VIII closed fractures and open fractures Gustillo gr 1/2

Exclusion criteria

Exclusion criteria: Fractures > 14 days old Gr 3 Gustillo classification Pre-existent arthritis of the wrist ASA IV-V No informed consent

Design outcomes

Primary

Measure	Time frame
Functional outcome scores (DASH, MAYO wrist score) and patient satisfaction score (SF 36), pain score (VAS)	—

Secondary

Measure	Time frame
Radiological findings, complications	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)