Clinical Trial: Volar Locked Plating vs Bridging External Fixation in Distal Radius Fracture

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary: 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)
Sponsor: Haukeland University Hospital

Current Primary Outcome:

  • Patient rated wrist evaluation (PRWE)score [ Time Frame: 3 months ]
  • Patient rated wrist evaluation (PRWE)score [ Time Frame: 6 weeks ]
  • Patient rated wrist evaluation (PRWE)score [ Time Frame: 12 months ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Quick-DASH score [ Time Frame: 6 weeks, 3 and 12 months ]
  • Pain VAS-score [ Time Frame: 6 weeks, 3 and 12 months ]
  • 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
  • Radiographic evaluation [ Time Frame: 6 weeks and 12 months ]
    Palmar tilt, Radial inclination, Ulnar variance, Fracture union


Original Secondary Outcome: Same as current

Information By: Haukeland University Hospital

Dates:
Date Received: June 20, 2013
Date Started: August 2013
Date Completion: December 2017
Last Updated: February 28, 2017
Last Verified: February 2017