Colles' Fracture Clinical Trial
Official title:
A Prospective Randomized Controlled Trial Comparing Circumferential Casting Versus Splinting in Displaced Colles' Fractures
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). Secondary outcomes were DASH score, return to work, activities of daily living
(ADL), wrist pain, range of motion (ROM) and grip strength.
Study Phase Phase 3 Study Type Interventional - Assigned to treatment Recruitment status
Completed 2003 Record Verification Date March 2003 Anticipated trial start date November
1998 Last Follow-Up Date December 2002 Data Entry Closure Date January 2004 Study Completion
Date July 2004 Purpose Treatment Allocation Randomized
Masking Single Blind Control Active Assignment Parallel Endpoints Efficacy Primary outcome
Radiologic slippage of fracture at 4 weeks post reduction
Key secondary outcomes Functional outcomes: DASH score, return to work, activities of daily
living (ADL), wrist pain, range of motion (ROM) and grip strength
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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