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

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

Study Overview

• Status: Completed
• Conditions: Colles' Fracture
• Intervention / Treatment: Device: Cylindrical cast; Device: Modified sugar tong cast; Device: Volar dorsal splint

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 Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V1Y 1Z1
      • Department of Emergency Medicine, St Paul's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1; Cylindrical cast	Device: Cylindrical cast; Arm cast/immobilization technique for wrist fracture
Active Comparator: 2; Modified sugar tong cast	Device: Modified sugar tong cast; Arm cast/immobilization technique for wrist fracture
Active Comparator: 3; Volar dorsal splint	Device: Volar dorsal splint; Arm cast/immobilization technique for wrist fracture

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Radiologic slippage of fracture at 4 weeks post reduction	4 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of British Columbia
• Collaborators: Smith & Nephew, Inc.
• Investigators: Principal Investigator: Robert Stenstrom, MD, Ph.D, University of British Columbia; Study Director: Eric Grafstein, MD, University of British Columbia

Study record dates

Study Major Dates

• Study Start: November 1, 1998
• Study Completion (Actual): January 1, 2004

Study Registration Dates

• First Submitted: June 23, 2008
• First Submitted That Met QC Criteria: June 24, 2008
• First Posted (Estimate): June 25, 2008

Study Record Updates

• Last Update Posted (Estimate): June 25, 2008
• Last Update Submitted That Met QC Criteria: June 24, 2008
• Last Verified: June 1, 2008

More Information

Terms related to this study

• Keywords: treatment; Emergency Department; RCT; splint; cast; Colles fracture treatment; Displaced fracture of distal radius; distal radius fracture treatment
• Additional Relevant MeSH Terms: Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Joint Dislocations; Fracture Dislocation; Radius Fractures; Fractures, Bone; Colles' Fracture; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Cysteine Proteinase Inhibitors; Calpastatin
• Other Study ID Numbers: P98-0172