Volar Locked Plating vs Bridging External Fixation in Distal Radius Fracture

Distal Radius Fracture Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01904084
• Other study ID #: 2013/555
• Status: Completed
• Phase: N/A
• Start date: August 2013
• Est. completion date: May 2018

Study information

• Verified date: June 2017
• Source: Haukeland University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: May 2018
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Distal Radius Fracture
• Fractures, Bone
• Radius Fractures

Intervention

Device:
• Volar locked plating
Operative treatment of distal radius fracture with volar locking plate
• Hoffman external fixator
Patients with distal radius fracture operated with Hoffman external fixator

Locations

Country	Name	City	State
Norway	Orthopaedic depatment, Voss hospital	Bergen	Voss

Sponsors (2)

Lead Sponsor	Collaborator
Haukeland University Hospital	Helse-Bergen HF

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Esposito J, Schemitsch EH, Saccone M, Sternheim A, Kuzyk PR. External fixation versus open reduction with plate fixation for distal radius fractures: a meta-analysis of randomised controlled trials. Injury. 2013 Apr;44(4):409-16. doi: 10.1016/j.injury.2012.12.003. Epub 2013 Jan 6. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient rated wrist evaluation (PRWE)score		3 months
Primary	Patient rated wrist evaluation (PRWE)score		6 weeks
Primary	Patient rated wrist evaluation (PRWE)score		12 months
Secondary	Quick-DASH score		6 weeks, 3 and 12 months
Secondary	Pain VAS-score		6 weeks, 3 and 12 months
Secondary	Complications	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	6 weeks, 3 and 12 months
Secondary	Radiographic evaluation	Palmar tilt, Radial inclination, Ulnar variance, Fracture union	6 weeks and 12 months