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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00704743
First Posted: June 25, 2008
Last Update Posted: June 25, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Smith & Nephew, Inc.
Information provided by:
University of British Columbia
  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
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Controlled Trial Comparing Circumferential Casting Versus Splinting in Displaced Colles' Fractures

Resource links provided by NLM:


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 ]

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 ]

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

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Dr. Robert Stenstrom, University of British Columbia
ClinicalTrials.gov Identifier: NCT00704743     History of Changes
Other Study ID Numbers: P98-0172
First Submitted: June 23, 2008
First Posted: June 25, 2008
Last Update Posted: June 25, 2008
Last Verified: June 2008

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:
Fractures, Bone
Colles' Fracture
Wounds and Injuries
Fracture Dislocation
Joint Dislocations
Bone Diseases
Musculoskeletal Diseases
Radius Fractures
Calpastatin
Cysteine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action