Clinical trial NCT00704743: A Trial Comparing Circumferential Casting Versus Splinting in Displaced Colles' Fractures
Official title: A Prospective Randomized Controlled Trial Comparing Circumferential Casting Versus Splinting in Displaced Colles' Fractures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Colles' Fracture
Keywords: Colles fracture treatment
Displaced fracture of distal radius
distal radius fracture treatment
RCT
Emergency Department
cast
splint
treatment
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Smith & Nephew, Inc.
First posted: 2008-06-25
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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). 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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Displaced fracture of distal radius requiring closed reduction

Exclusion Criteria:

* Open fracture
* Previous displaced fracture involving the same or contralateral distal radius
* neuromuscular deficits or CVA of either upper extremity that impaired functional outcome assessment
* concurrent carpal bone fractures or dislocations - - unstable fractures requiring primary open reduction and internal fixation
* skin allergy or sensitivity to either of the immobilization materials
* Smith's, Barton's or Chauffeur fractures
* Neurovascular compromise of the affected limb - - Bilateral distal radius fractures that prevented follow-up comparison with a normal contralateral limb
* Other significant and concurrent injuries in the ipsilateral extremity.
* Undisplaced distal radius fracture
* Reduction performed in the ED did not meet criteria for successful fracture reduction

Primary outcomes:
measure: Radiologic slippage of fracture at 4 weeks post reduction
timeFrame: 4 weeks
Secondary outcomes:
measure: Functional outcomes: DASH score, return to work, activities of daily living (ADL), wrist pain, range of motion (ROM) and grip strength
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Department of Emergency Medicine, St Paul's Hospital
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Robert Stenstrom, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: University of British Columbia
name: Eric Grafstein, MD
role: STUDY_DIRECTOR
References: