Volar Locked Plating vs Bridging External Fixation in Distal Radius Fracture

NCT ID: NCT01904084

Last Updated: 2019-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2018-05-31

Brief Summary

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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

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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)

Conditions

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Distal Radius Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Volar locked plating

One group with distal radius fracture is operated with Locking plate

Group Type ACTIVE_COMPARATOR

Volar locked plating

Intervention Type DEVICE

Operative treatment of distal radius fracture with volar locking plate

Hoffman external fixator

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

Group Type ACTIVE_COMPARATOR

Hoffman external fixator

Intervention Type DEVICE

Patients with distal radius fracture operated with Hoffman external fixator

Interventions

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Volar locked plating

Operative treatment of distal radius fracture with volar locking plate

Intervention Type DEVICE

Hoffman external fixator

Patients with distal radius fracture operated with Hoffman external fixator

Intervention Type DEVICE

Other Intervention Names

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DVR Anatomic plate, Hand Innovations, De Puy Bridging Hoffman II Compact, Stryker

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Helse-Bergen HF

OTHER

Sponsor Role collaborator

Haukeland University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Trine Ludvigsen, Md

Role: PRINCIPAL_INVESTIGATOR

Locations

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Orthopaedic depatment, Voss hospital

Bergen, Voss, Norway

Site Status

Countries

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Norway

References

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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.

Reference Type BACKGROUND
PMID: 23298757 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34746674 (View on PubMed)

Other Identifiers

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2013/555

Identifier Type: -

Identifier Source: org_study_id

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