Colles' FracturePhase 3NCT00704743
A Trial Comparing Circumferential Casting Versus Splinting in Displaced Colles' Fractures
A Phase 3 study testing Cylindrical cast, Modified sugar tong cast and Volar dorsal splint in people with Colles' Fracture, run by University of British Columbia at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colles' Fracture
- What is being tested?
- Cylindrical cast, Modified sugar tong cast and Volar dorsal splint
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- Nov 1998to Jan 2004
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Displaced fracture of distal radius requiring closed reduction
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Department of Emergency Medicine, St Paul's Hospital
Vancouver, British Columbia, V1Y 1Z1
About this study
Official title: 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.
Read more
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
Read the 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.
- Conditions
- Colles' Fracture
- Being tested
- Cylindrical cast, Modified sugar tong cast, Volar dorsal splint
- Keywords
- Colles fracture treatment, Displaced fracture of distal radius, distal radius fracture treatment, RCT, Emergency Department, cast, splint, treatment
- Medical subject headings
- Colles' Fracture, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cylindrical castDevice
Arm cast/immobilization technique for wrist fracture
Modified sugar tong castDevice
Arm cast/immobilization technique for wrist fracture
Volar dorsal splintDevice
Arm cast/immobilization technique for wrist fracture
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Cylindrical cast Receives: Device: Cylindrical cast |
| 2 | Active comparator | Modified sugar tong cast Receives: Device: Modified sugar tong cast |
| 3 | Active comparator | Volar dorsal splint Receives: Device: Volar dorsal splint |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiologic slippage of fracture at 4 weeks post reduction
Measured: 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
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2008 (estimated)
- Study startNov 1998
- Study completionJan 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colles' FractureStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Smith & Nephew, Inc.
- Investigators
- Robert Stenstrom, MD, Ph.D, Principal investigator, University of British ColumbiaEric Grafstein, MD, Study director, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00704743
- Sponsor's protocol ID
- P98-0172
- Status last verified
- Jun 2008
- First submitted
- 23 Jun 2008
- Last updated
- 25 Jun 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Trial Comparing Circumferential Casting Versus Splinting in Displaced Colles' Fractures
- ClinicalTrials.gov ID
- NCT00704743
- Acronym / sponsor ID
- P98-0172
- Conditions
- Colles' Fracture
- Keywords
- Colles fracture treatment, Displaced fracture of distal radius, distal radius fracture treatment, RCT, Emergency Department, cast, splint, treatment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Smith & Nephew, Inc.
- Study start
- Nov 1998
- Study completion
- Jan 2004 (actual)
- First posted
- 25 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: Cylindrical castCylindrical cast |
| 2 | Active comparator | Device: Modified sugar tong castModified sugar tong cast |
| 3 | Active comparator | Device: Volar dorsal splintVolar dorsal splint |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age > 18 years
- Displaced fracture of distal radius requiring closed reduction
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cylindrical castArm cast/immobilization technique for wrist fracture | Device | 1 |
| Modified sugar tong castArm cast/immobilization technique for wrist fracture | Device | 2 |
| Volar dorsal splintArm cast/immobilization technique for wrist fracture | Device | 3 |
Primary outcome
Radiologic slippage of fracture at 4 weeks post reduction
Time frame: 4 weeks
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2008.
Related trials for Colles' Fracture
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Brachial Plexus Nerve Block Versus Haematoma Block for Closed Reduction of Distal Radius Fracture in Adults - The BLOCK Trial. A Multicentre Randomised Controlled Trial.
Distal Radius Fractures, Fracture Dislocation
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Wrist Injury Strengthening Exercise (WISE) Versus Usual Care Advice for Improving Pain and Function
Distal Radius Fracture, Colles Fracture
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Comparative Study Between Cannulated Screws and K-wires in the Fixation of Distal Radius Fractures
Distal Radius Fractures
Not yet recruiting
Comparison of Functional Outcomes of Closed Reduction With Cast Versus Closed Reduction With K-Wire Fixation in Colles' Fracture
Colles' Fracture
Recruiting
Comparison of Kaltenborn Mobilization and Mobilization With Movement (MWM) in Wrist Hypomobility After Colle's Fracture
Colles Fracture, Hypomobility
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Stenstrom, MD, Ph.D principal investigator
University of British Columbia
Eric Grafstein, MD study director
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cylindrical cast, Modified sugar tong cast and Volar dorsal splint in people with Colles' Fracture, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiologic slippage of fracture at 4 weeks post reduction (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2008.