Volar Locked Plating vs Bridging External Fixation in Distal Radius Fracture

A Randomized, Prospective Comparison of Volar Locked Plating Versus Hoffman II Bridging External Fixation in Patients With Dislocated Distal Radius Fractures, AO/OTA Type A.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01904084

Enrollment

160

Registered

2013-07-22

Start date

2013-08-31

Completion date

2018-05-31

Last updated

2019-08-28

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

Conditions

Distal Radius Fracture

Keywords

Distal radius fracture

Brief summary

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

Detailed 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)

Interventions

DEVICEVolar locked plating

Operative treatment of distal radius fracture with volar locking plate

DEVICEHoffman external fixator

Patients with distal radius fracture operated with Hoffman external fixator

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame
Patient rated wrist evaluation (PRWE)score	3 months

Secondary

Measure	Time frame	Description
Quick-DASH score	6 weeks, 3 and 12 months	—
Pain VAS-score	6 weeks, 3 and 12 months	—
Complications	6 weeks, 3 and 12 months	Number of patients with per- and postoperative complications will be registrated. Types of expected complications: Tendon rupture, Tendon irritation, Carpal Tunnel Syndrome, Complex Regional Pain Syndrome, Screw displacement/screw loosening, Delayed fracture union
Radiographic evaluation	6 weeks and 12 months	Palmar tilt, Radial inclination, Ulnar variance, Fracture union

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026