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

NCT00704743 | Completed Phase 3

• 1 other identifier: P98-0172
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Conditions

Colles' Fracture

Keywords

Colles fracture treatment; Displaced fracture of distal radius; distal radius fracture treatment; RCT; Emergency Department; cast; splint; treatment

Outcome Measures

Primary Outcomes (1)

• Radiologic slippage of fracture at 4 weeks post reduction

  4 weeks

Secondary Outcomes (1)

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

  4 weeks

Study Arms (3)

1

ACTIVE COMPARATOR

Cylindrical cast

Device: Cylindrical cast

2

ACTIVE COMPARATOR

Modified sugar tong cast

Device: Modified sugar tong cast

3

ACTIVE COMPARATOR

Volar dorsal splint

Device: Volar dorsal splint

Interventions

Cylindrical cast DEVICE

Arm cast/immobilization technique for wrist fracture

1

Modified sugar tong cast DEVICE

Arm cast/immobilization technique for wrist fracture

2

Volar dorsal splint DEVICE

Arm cast/immobilization technique for wrist fracture

3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead
• Smith & Nephew, Inc.: collaborator

Study Sites (1)

Department of Emergency Medicine, St Paul's Hospital

Vancouver, British Columbia, V1Y 1Z1, Canada

Location

MeSH Terms

Conditions

Colles' Fracture; Emergencies

Condition Hierarchy (Ancestors)

Fracture Dislocation; Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries; Radius Fractures; Fractures, Bone; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Robert Stenstrom, MD, Ph.D

  University of British Columbia

  PRINCIPAL INVESTIGATOR

• Eric Grafstein, MD

  University of British Columbia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 23, 2008
• First Posted: June 25, 2008
• Study Start: November 1, 1998
• Study Completion: January 1, 2004
• Last Updated: June 25, 2008

Record last verified: 2008-06

Locations

CA (1)