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Volar Locked Plating vs Bridging External Fixation in Distal Radius Fracture

H

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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