Volar Locked Plating vs Bridging External Fixation in Distal Radius Fracture

Haukeland University Hospital

Status: Completed

Conditions: Distal Radius Fracture

Treatments: Device: Volar locked plating; Device: Hoffman external fixator

Study type: Interventional

Funder types: Other

Identifiers

NCT01904084

2013/555

Details and patient eligibility

About

The purpose of this study is to evaluate function, pain and radiographic evaluation in patients treated with volar locked plating versus Hoffman II bridging external fixation in patients with extraarticular distal radius fractures, AO/OTA type A

Full description

We have designed a randomized prospective study for comparison of volar locked plating versus Hoffman II bridging external fixation in patients with extraarticular dislocated distal radius fractures AO/OTA type A3. On the basis of power analysis a total of 160 patients are to be included in this project. The follow-up period is 1 year and evaluation is based on x-ray analysis, grip strength, range of motion, pain and satisfaction with the treatment ( PRWE, Quick-DASH)

Enrollment: 160 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with dislocated extraarticular distal radius fracture age 18-70 years

Exclusion criteria

• Cognitively impaired
• Drug abuse
• Congenital bone disease
• Earlier wrist injury
• Open fracture, Gustilo-Anderson type 3
• Pathological fractures( except osteoporotic fractures)
• Tourists

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

Volar locked plating

Active Comparator group

Description:

One group with distal radius fracture is operated with Locking plate

Treatment:

Device: Volar locked plating

Hoffman external fixator

Active Comparator group

Description:

One group with distal radius fracture is operated with Hoffman external fixator

Treatment:

Device: Hoffman external fixator