NCT01904084

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 20, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 22, 2013

Completed
10 days until next milestone

Study Start

First participant enrolled

August 1, 2013

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

August 28, 2019

Status Verified

June 1, 2017

Enrollment Period

3.8 years

First QC Date

June 20, 2013

Last Update Submit

August 26, 2019

Conditions

Distal Radius Fracture

Keywords

Distal radius fracture

Outcome Measures

Primary Outcomes (3)

  • Patient rated wrist evaluation (PRWE)score

    3 months

  • Patient rated wrist evaluation (PRWE)score

    6 weeks

  • Patient rated wrist evaluation (PRWE)score

    12 months

Secondary Outcomes (4)

  • 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

  • Radiographic evaluation

    6 weeks and 12 months

Study Arms (2)

Volar locked plating

ACTIVE COMPARATOR

One group with distal radius fracture is operated with Locking plate

Device: Volar locked plating

Hoffman external fixator

ACTIVE COMPARATOR

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

Device: Hoffman external fixator

Interventions

Volar locked platingDEVICE

Operative treatment of distal radius fracture with volar locking plate

Also known as: DVR Anatomic plate, Hand Innovations, De Puy
Volar locked plating
Hoffman external fixatorDEVICE

Patients with distal radius fracture operated with Hoffman external fixator

Also known as: Bridging Hoffman II Compact, Stryker
Hoffman external fixator

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Orthopaedic depatment, Voss hospital

Bergen, Voss, 5700, Norway

Location

Related Publications (2)

  • 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.

    PMID: 23298757BACKGROUND

  • Ludvigsen T, Matre K, Vetti N, Kristoffersen PM, Toppe MK, Gudmundsdottir R, Krukhaug Y, Dybvik E, Fevang JM. Is there a correlation between functional results and radiographic findings in patients with distal radius fracture A0 type A3 treated with volar locking plate or external fixator? OTA Int. 2021 Aug 9;4(3):e142. doi: 10.1097/OI9.0000000000000142. eCollection 2021 Sep.

    PMID: 34746674DERIVED

MeSH Terms

Conditions

Wrist Fractures

Condition Hierarchy (Ancestors)

Wrist InjuriesArm InjuriesWounds and InjuriesFractures, Bone

Study Officials

  • Trine Ludvigsen, Md

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2013

First Posted

July 22, 2013

Study Start

August 1, 2013

Primary Completion

May 1, 2017

Study Completion

May 1, 2018

Last Updated

August 28, 2019

Record last verified: 2017-06

Locations

NO(1)