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Volar Locked Plating vs Bridging External Fixation in Distal Radius Fracture

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01904084
Recruitment Status : Completed
First Posted : July 22, 2013
Last Update Posted : August 28, 2019
Sponsor:
Collaborator:
Helse-Bergen HF
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Distal Radius Fracture Device: Volar locked plating Device: Hoffman external fixator Not Applicable

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)

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : August 2013
Actual Primary Completion Date : May 2017
Actual Study Completion Date : May 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Volar locked plating
One group with distal radius fracture is operated with Locking plate
Device: Volar locked plating
Operative treatment of distal radius fracture with volar locking plate
Other Name: DVR Anatomic plate, Hand Innovations, De Puy

Active Comparator: Hoffman external fixator
One group with distal radius fracture is operated with Hoffman external fixator
Device: Hoffman external fixator
Patients with distal radius fracture operated with Hoffman external fixator
Other Name: Bridging Hoffman II Compact, Stryker




Primary Outcome Measures :
  1. Patient rated wrist evaluation (PRWE)score [ Time Frame: 3 months ]
  2. Patient rated wrist evaluation (PRWE)score [ Time Frame: 6 weeks ]
  3. Patient rated wrist evaluation (PRWE)score [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Quick-DASH score [ Time Frame: 6 weeks, 3 and 12 months ]
  2. Pain VAS-score [ Time Frame: 6 weeks, 3 and 12 months ]
  3. Complications [ Time Frame: 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

  4. Radiographic evaluation [ Time Frame: 6 weeks and 12 months ]
    Palmar tilt, Radial inclination, Ulnar variance, Fracture union



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01904084


Locations
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Norway
Orthopaedic depatment, Voss hospital
Bergen, Voss, Norway, 5700
Sponsors and Collaborators
Haukeland University Hospital
Helse-Bergen HF
Investigators
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Principal Investigator: Trine Ludvigsen, Md
Publications:
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Responsible Party: Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT01904084    
Other Study ID Numbers: 2013/555
First Posted: July 22, 2013    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: June 2017
Keywords provided by Haukeland University Hospital:
Distal radius fracture
Additional relevant MeSH terms:
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Fractures, Bone
Radius Fractures
Wounds and Injuries
Forearm Injuries
Arm Injuries