Minimax study; open reduction and internal fixation with volar fixed-angle plating vs percutaneous reduction and external fixation for displaced intra-articular fractures of the distal radius in the eldery

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON22659

Enrollment

148

Registered

2008-06-18

Start date

2008-03-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Displaced intra-articular distal radius fractures in the eldery (gedisloceerde intra-articulare distale radius fracturen bij de oudere patienten)

Interventions

This study will randomise between: 1. Open reduction and internal fixation via a volar approach using volar fixed-angle locking plates and 2. Closed reduction, percutaneous pinnen and fixation, an

Eligibility

Inclusion criteria

Inclusion criteria: 1. All patients with a displaced intra-articular fracture of the distal radius. 2. More than 50 years old. 3. Compos Mentis. 4. Living in the Netherlands. 5. Informed Consent. 6. Closed fractures or open fractures Gustillo 1-2.

Exclusion criteria

Exclusion criteria: 1. a fracture older than 14 days. 2. Grade III open fractures. 3. ASA IV-V. 4. Participation in other studys. 5. Severe Wrist artrose or limited wrist motion before fracture. 6. Fractures on both sides (left and right). 7. Chronic substance abusus.

Design outcomes

Primary

Measure	Time frame
The primairy outcome measures are: - wrist function (DASH, Mayo Wrist Score) - patient satisfaction (SF-36) - pain sensation (VAS).	—

Secondary

Measure	Time frame
Secondary outcomes are: - radiographic parameters - the number of complications	—

Contacts

Public ContactJ. Keizer

Medical Center Haaglanden Lijnbaan 32

j.keizer@lumc.nl+31 (0)70 3302000

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)