Volar Locked Plating vs Bridging External Fixation in Distal Radius Fracture

Not Applicable

Completed

• Conditions: Distal Radius Fracture
• Interventions: Device: Volar locked plating; Device: Hoffman external fixator

• Registration Number: NCT01904084
• Lead Sponsor: Haukeland University Hospital

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)

Study Timeline

• Study First Submitted: 2013-06-20
• Study First Submitted QC: 2013-07-19
• Study First Posted: 2013-07-22
• Study Start: 2013-08
• Primary Completion: 2017-05
• Status Verified: 2017-06
• Study Completion: 2018-05
• Last Update Submitted: 2019-08-26
• Last Update Posted: 2019-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Volar locked plating	Volar locked plating	One group with distal radius fracture is operated with Locking plate
Hoffman external fixator	Hoffman external fixator	One group with distal radius fracture is operated with Hoffman external fixator

Primary Outcome Measures

Name	Time	Method
Patient rated wrist evaluation (PRWE)score	12 months

Secondary Outcome Measures

Name	Time	Method
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
Quick-DASH score	6 weeks, 3 and 12 months
Pain VAS-score	6 weeks, 3 and 12 months

Trial Locations

Locations (1)

Orthopaedic depatment, Voss hospital; 🇳🇴 Bergen, Voss, Norway