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

Phase 3

Completed

• Conditions: Colles' Fracture
• Interventions: Device: Cylindrical cast; Device: Modified sugar tong cast; Device: Volar dorsal splint

• Registration Number: NCT00704743
• Lead Sponsor: University of British Columbia

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.

Study Timeline

• Study Start: 1998-11
• Study Completion: 2004-01
• Status Verified: 2008-06
• Study First Submitted: 2008-06-23
• Study First Submitted QC: 2008-06-24
• Last Update Submitted: 2008-06-24
• Study First Posted: 2008-06-25
• Last Update Posted: 2008-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Cylindrical cast	Cylindrical cast
2	Modified sugar tong cast	Modified sugar tong cast
3	Volar dorsal splint	Volar dorsal splint

Primary Outcome Measures

Name	Time	Method
Radiologic slippage of fracture at 4 weeks post reduction	4 weeks

Secondary Outcome Measures

Name	Time	Method
Functional outcomes: DASH score, return to work, activities of daily living (ADL), wrist pain, range of motion (ROM) and grip strength	4 weeks

Trial Locations

Locations (1)

Department of Emergency Medicine, St Paul's Hospital; 🇨🇦 Vancouver, British Columbia, Canada