Dorsal Splint or Circular Cast for Colles' Fracture? | NCT00470691

Studies
Dorsal Splint or Circular Cast for Colles' Fracture?

NCT00470691

Sponsor

St. Olavs Hospital

Status

Completed

Last Update Posted

Apr 8, 2015Estimated

Enrollment

72Actual

Phase

Not Applicable

Conditions

Colles' Fracture

Interventions

plaster cast
dorsal splint

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2004

Primary Completion Date

Jan 2008Actual

Completion Date

Jun 2008Actual

First Submitted Date

May 7, 2007

First Submission Date that Met QC Criteria

May 7, 2007

First Posted Date

May 8, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 7, 2015

Last Update Posted Date

Apr 8, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

At our hospital, all Colles' fractures deemed suitable for conservative treatment are reduced and immobilised with a plaster of Paris dorsal splint which is converted to a complete cast after 10 days. According to individual factors such as age, general health and radiological results after 10 days, some patients with severe redisplacement are readmitted to hospital for surgery.

The main purpose of this study is to determine whether, during the first 10 days of immobilisation, a complete plaster cast or a dorsal plaster splint best retains the alignment of a reduced Colles' fracture. In addition, we aim to compare the complication rates of the two methods.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

72Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
complete plaster cast	Experimental	reduction and a complete plaster cast,	Procedure: plaster cast
dorsal plaster splint	Active Comparator	reduction and a dorsal plaster splint.	Procedure: dorsal splint

Interventions

Name	Type	Description	Arm Group Labels	Other Names
plaster cast	Procedure	complete circular plaster cast	complete plaster cast

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
redisplacement	dorsal angulation, radial tilt and radial shortening - radiographs	10 days

Secondary Outcomes

Measure	Description	Time Frame
pain	pain during past 24h on a VAS	10 days
number of analgesic tablets	number of analgesic tablets taken during the 10 days after reduction.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

women 50 years and older
Colles' fracture due to low energy trauma

Exclusion Criteria:

high energy trauma
age under 50 years
dementia

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Vilh Finsen, MD, PhD	Dept of orthopaedic Surgery, St Olavs Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St. Olavs Hospital		Trondheim			Norway

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19195651	Result	Wik TS, Aurstad AT, Finsen V. Colles' fracture: dorsal splint or complete cast during the first 10 days? Injury. 2009 Apr;40(4):400-4. doi: 10.1016/j.injury.2008.08.044. Epub 2009 Feb 4.

ID	Term
D000072039	Fracture Dislocation
D004204	Joint Dislocations
D007592	Joint Diseases
D009140	Musculoskeletal Diseases

ID	Term
D016267	External Fixators
D009984	Orthopedic Fixation Devices
D009983	Orthopedic Equipment
D013523	Surgical Equipment