A Trial Comparing Circumferential Casting Versus Splinting in Displaced Colles' Fractures

Colles' Fracture Clinical Trial

Official title:

A Prospective Randomized Controlled Trial Comparing Circumferential Casting Versus Splinting in Displaced Colles' Fractures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00704743
• Other study ID #: P98-0172
• Status: Completed
• Phase: Phase 3
• First received: June 23, 2008
• Last updated: June 24, 2008
• Start date: November 1998
• Est. completion date: January 2004

Study information

• Verified date: June 2008
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: January 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colles' Fracture
• Fractures, Bone

Intervention

Device:
• Cylindrical cast
Arm cast/immobilization technique for wrist fracture
• Modified sugar tong cast
Arm cast/immobilization technique for wrist fracture
• Volar dorsal splint
Arm cast/immobilization technique for wrist fracture

Locations

Country	Name	City	State
Canada	Department of Emergency Medicine, St Paul's Hospital	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	Smith & Nephew, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiologic slippage of fracture at 4 weeks post reduction		4 weeks	No
Secondary	Functional outcomes: DASH score, return to work, activities of daily living (ADL), wrist pain, range of motion (ROM) and grip strength		4 weeks	No