Clinical Trial: A Trial Comparing Circumferential Casting Versus Splinting in Displaced Colles' Fractures
Study Status: Completed
Recruit Status: Completed
Study Type:
Primary: To determine the effectiveness of three immob
Official Title: A Prospective Randomized Controlled Trial Comparing Circumferential Casting Versus Splinting in Displaced Colles' Fractures
Brief Summary:
Displaced fractures of the distal radius requiring closed reduction (otherwise known as Colles fractures) are common in the emergency department. The purpose of the study is to determine if there is any difference between 3 methods of immobilization for these fractures: circumferential cast, volar-dorsal splint, and modified sugar tong splint. Maintenance of position was assessed at 4 weeks after the injury and wrist strength and function were assessed at 2 months and 6 months. We hypothesize that there will not be a clinically important difference between these methods of immobilizing for displaced fractures of the distal radius requiring closed reduction.
Extended description of the protocol, including information not already contained in other fields.
Objectives:
Primary: To determine the effectiveness of three immobilization methods (circumferential cast [CC], volar dorsal splint [VDS], modified sugar-tong [MST] splint) in maintaining the position of displaced distal radius fractures after successful closed reduction.
Secondary to assess long term functional outcomes associated with fiberglass splint immobilization versus standard cylindrical casting in patients maintaining initial non-operative reductions.
Design: Randomized prospective single blind controlled trial Patients/Participants: Patients over 18 years of age who presented to the emergency department with a displaced fracture of the distal radius, requiring closed reduction.
Outcome Measurements: Loss of reduction (radiological slippage or the need for surgical fixation during the 3-4 week primary immobilization period after initial successful reduction). Seconda
Detailed Summary:
Primary: To determine the effectiveness of three immobilization methods (circumferential cast [CC], volar dorsal splint [VDS], modified sugar-tong [MST] splint) in maintaining the position of displaced distal radius fractures after successful closed reduction.
Secondary to assess long term functional outcomes associated with fiberglass splint immobilization versus standard cylindrical casting in patients maintaining initial non-operative reductions.
Design: Randomized prospective single blind controlled trial Patients/Participants: Patients over 18 years of age who presented to the emergency department with a displaced fracture of the distal radius, requiring closed reduction.
Outcome Measurements: Loss of reduction (radiological slippage or the need for surgical fixation during the 3-4 week primary immobilization period after initial successful reduction). Secondary outcomes were DASH score, return to work, activities of daily living (ADL), wrist pain, range of motion (ROM) and grip strength.
Sponsor: University of British Columbia
Current Primary Outcome: Radiologic slippage of fracture at 4 weeks post reduction [ Time Frame: 4 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Functional outcomes: DASH score, return to work, activities of daily living (ADL), wrist pain, range of motion (ROM) and grip strength [ Time Frame: 4 weeks ]
Original Secondary Outcome: Same as current
Information By: University of British Columbia
Dates:
Date Received: June 23, 2008
Date Started: November 1998
Date Completion:
Last Updated: June 24, 2008
Last Verified:
Primary: To determine the effectiveness of three immob
