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

This study has been completed.
Sponsor:
Collaborator:
Smith & Nephew, Inc.
Information provided by:
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00704743
First received: June 23, 2008
Last updated: June 24, 2008
Last verified: June 2008
History of Changes
  Purpose

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


Condition Intervention Phase
Colles' Fracture
 Device: Cylindrical cast
Device: Modified sugar tong cast
Device: Volar dorsal splint
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Controlled Trial Comparing Circumferential Casting Versus Splinting in Displaced Colles' Fractures

Resource links provided by NLM:

MedlinePlus related topics: Flu Fractures
U.S. FDA Resources

Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Radiologic slippage of fracture at 4 weeks post reduction [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Functional outcomes: DASH score, return to work, activities of daily living (ADL), wrist pain, range of motion (ROM) and grip strength [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 120
Study Start Date: November 1998
Study Completion Date: January 2004
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00704743

Locations
Canada, British Columbia
Department of Emergency Medicine, St Paul's Hospital
Vancouver, British Columbia, Canada, V1Y 1Z1
Sponsors and Collaborators
University of British Columbia
Smith & Nephew, Inc.
Investigators
Principal Investigator: Robert Stenstrom, MD, Ph.D University of British Columbia
Study Director: Eric Grafstein, MD University of British Columbia
  More Information

No publications provided

Responsible Party: Dr. Robert Stenstrom, University of British Columbia
ClinicalTrials.gov Identifier: NCT00704743     History of Changes
Other Study ID Numbers: P98-0172
Study First Received: June 23, 2008
Last Updated: June 24, 2008
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Colles fracture treatment
Displaced fracture of distal radius
distal radius fracture treatment
RCT
 Emergency Department
cast
splint
treatment

Additional relevant MeSH terms:
Colles' Fracture
Fractures, Bone
Radius Fractures
Wounds and Injuries

ClinicalTrials.gov processed this record on May 23, 2013