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Volar Locked Plating vs Bridging External Fixation in Distal Radius Fracture

Primary Purpose

Distal Radius Fracture

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Volar locked plating
Hoffman external fixator
Sponsored by
Haukeland University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Distal Radius Fracture focused on measuring Distal radius fracture

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Orthopaedic depatment, Voss hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Volar locked plating

Hoffman external fixator

Arm Description

One group with distal radius fracture is operated with Locking plate

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

Outcomes

Primary Outcome Measures

Patient rated wrist evaluation (PRWE)score
Patient rated wrist evaluation (PRWE)score
Patient rated wrist evaluation (PRWE)score

Secondary Outcome Measures

Quick-DASH score
Pain VAS-score
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
Radiographic evaluation
Palmar tilt, Radial inclination, Ulnar variance, Fracture union

Full Information

First Posted
June 20, 2013
Last Updated
August 26, 2019
Sponsor
Haukeland University Hospital
Collaborators
Helse-Bergen HF
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1. Study Identification

Unique Protocol Identification Number
NCT01904084
Brief Title
Volar Locked Plating vs Bridging External Fixation in Distal Radius Fracture
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.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
May 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Haukeland University Hospital
Collaborators
Helse-Bergen HF

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Distal Radius Fracture
Keywords
Distal radius fracture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Volar locked plating
Arm Type
Active Comparator
Arm Description
One group with distal radius fracture is operated with Locking plate
Arm Title
Hoffman external fixator
Arm Type
Active Comparator
Arm Description
One group with distal radius fracture is operated with Hoffman external fixator
Intervention Type
Device
Intervention Name(s)
Volar locked plating
Other Intervention Name(s)
DVR Anatomic plate, Hand Innovations, De Puy
Intervention Description
Operative treatment of distal radius fracture with volar locking plate
Intervention Type
Device
Intervention Name(s)
Hoffman external fixator
Other Intervention Name(s)
Bridging Hoffman II Compact, Stryker
Intervention Description
Patients with distal radius fracture operated with Hoffman external fixator
Primary Outcome Measure Information:
Title
Patient rated wrist evaluation (PRWE)score
Time Frame
3 months
Title
Patient rated wrist evaluation (PRWE)score
Time Frame
6 weeks
Title
Patient rated wrist evaluation (PRWE)score
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Quick-DASH score
Time Frame
6 weeks, 3 and 12 months
Title
Pain VAS-score
Time Frame
6 weeks, 3 and 12 months
Title
Complications
Description
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
Time Frame
6 weeks, 3 and 12 months
Title
Radiographic evaluation
Description
Palmar tilt, Radial inclination, Ulnar variance, Fracture union
Time Frame
6 weeks and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Trine Ludvigsen, Md
Official's Role
Principal Investigator
Facility Information:
Facility Name
Orthopaedic depatment, Voss hospital
City
Bergen
State/Province
Voss
ZIP/Postal Code
5700
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
23298757
Citation
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.
Results Reference
background
PubMed Identifier
34746674
Citation
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.
Results Reference
derived

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Volar Locked Plating vs Bridging External Fixation in Distal Radius Fracture

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