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Completed

NCT Number: NCT01904084

Volar Locked Plating vs Bridging External Fixation in Distal Radius Fracture

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

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Key information

Conditions

Distal Radius Fracture Arm Injuries Fractures, Bone Wounds and Injuries Wrist Fractures Wrist Injuries

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Orthopaedic depatment, Voss hospital

Bergen, Voss, 5700, Norway

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Volar locked plating

Device

Operative treatment of distal radius fracture with volar locking plate

Other names: DVR Anatomic plate, Hand Innovations, De Puy

Hoffman external fixator

Device

Patients with distal radius fracture operated with Hoffman external fixator

Other names: Bridging Hoffman II Compact, Stryker

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Haukeland University Hospital

Other

Collaborators

  • Helse-Bergen HF

Registry information

Official study 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.

Important dates

Study start
2013
Primary completion
2017
Study completion
2018
First posted
Jul 22, 2013
Registry last updated
Aug 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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