Short Versus Conventional Plaster Cast Fixation Time in Reduced Distal Radius Fractures (GitRa)
Primary Purpose
Colles' Fracture
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
10-day cast
Sponsored by
About this trial
This is an interventional treatment trial for Colles' Fracture
Eligibility Criteria
Inclusion Criteria:
- Distal radius fracture with intact ulna (except for processus styloideus ulnae)
- Dorsal angulation 5-40 degrees
- Axial compression < 4 mm
- Intra articular step-off < 1 mm
- Low energy trauma
- Closed fracture
- Suitable for treatment with closed reduction and plaster cast fixation
Exclusion Criteria:
- Fracture older than 3 Days
- Previously fractured ipsi- or contralateral wrist
- Dementia
- Inflammatory joint disorder
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
10-day cast
1-month cast
Arm Description
Removal of plaster cast 10 Days after reduction
Removal of plaster cast 1 month after reduction
Outcomes
Primary Outcome Measures
Radiographic displacement
Change in dorsal angulation, radial angulation and axial compression between follow-ups.
Secondary Outcome Measures
Grip strength
Grip strength compared to uninjured side at 1, 4 and 12 months
Range of motion
Range of motion in dorsal extension, volar flexion, supination and pronation compared to uninjured side at 1, 4 and 12 months.
Assessment of pain intensity
Average pain over the last 24 h assessed with a visual analogue scale (VAS) at 10 days, 1, 4 and 12 months
Assessment of functional outcome with three different functional assessment scores; 1,The modified de Bruijn wrist score 2, The modified Mayo wrist scoring chart 3, The Gartland and Werley Demerit wrist point system modified by Sarmiento.
The three functional assessment scores are composite outcome measures consisting of multiple measures (results to be reported as single values for each Group),
Full Information
NCT ID
NCT02798614
First Posted
June 1, 2016
Last Updated
June 14, 2016
Sponsor
Uppsala University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02798614
Brief Title
Short Versus Conventional Plaster Cast Fixation Time in Reduced Distal Radius Fractures
Acronym
GitRa
Official Title
A Comparison of Radiographic and Clinical Results After Short Versus Conventional Plaster Cast Fixation Time in Reduced Distal Radius Fractures
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
September 2002 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Uppsala University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to compare the radiographic and clinical outcomes after short versus conventional plaster cast fixation time in reduced distal radius fractures.
Detailed Description
Displaced distal radius fractures treated with closed reduction and plaster cast fixation are radiographed 10 days (range 8-13 days) after reduction and randomized to one of two study arms; immediate removal of plaster cast or continued fixation in plaster cast for another 3 weeks. Radiographic and Clinical outcome measurements at 1, 4 and 12 months
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colles' Fracture
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
109 (Actual)
8. Arms, Groups, and Interventions
Arm Title
10-day cast
Arm Type
Active Comparator
Arm Description
Removal of plaster cast 10 Days after reduction
Arm Title
1-month cast
Arm Type
No Intervention
Arm Description
Removal of plaster cast 1 month after reduction
Intervention Type
Device
Intervention Name(s)
10-day cast
Intervention Description
Removal of plaster cast fixation 10 days after reduction
Primary Outcome Measure Information:
Title
Radiographic displacement
Description
Change in dorsal angulation, radial angulation and axial compression between follow-ups.
Time Frame
At admission, 10 days, 1 month and 12 months
Secondary Outcome Measure Information:
Title
Grip strength
Description
Grip strength compared to uninjured side at 1, 4 and 12 months
Time Frame
Uninjured side. Injured side at 1, 4 , 12 months
Title
Range of motion
Description
Range of motion in dorsal extension, volar flexion, supination and pronation compared to uninjured side at 1, 4 and 12 months.
Time Frame
Uninjured side. Injured side at 1, 4 and 12 months
Title
Assessment of pain intensity
Description
Average pain over the last 24 h assessed with a visual analogue scale (VAS) at 10 days, 1, 4 and 12 months
Time Frame
10 days, 1, 4 and 12 months
Title
Assessment of functional outcome with three different functional assessment scores; 1,The modified de Bruijn wrist score 2, The modified Mayo wrist scoring chart 3, The Gartland and Werley Demerit wrist point system modified by Sarmiento.
Description
The three functional assessment scores are composite outcome measures consisting of multiple measures (results to be reported as single values for each Group),
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Distal radius fracture with intact ulna (except for processus styloideus ulnae)
Dorsal angulation 5-40 degrees
Axial compression < 4 mm
Intra articular step-off < 1 mm
Low energy trauma
Closed fracture
Suitable for treatment with closed reduction and plaster cast fixation
Exclusion Criteria:
Fracture older than 3 Days
Previously fractured ipsi- or contralateral wrist
Dementia
Inflammatory joint disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Albert Christersson, MD
Organizational Affiliation
Department of Orthopaedics, University Hospital of Uppsala
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
27871284
Citation
Christersson A, Larsson S, Ostlund B, Sanden B. Radiographic results after plaster cast fixation for 10 days versus 1 month in reduced distal radius fractures: a prospective randomised study. J Orthop Surg Res. 2016 Nov 21;11(1):145. doi: 10.1186/s13018-016-0478-7.
Results Reference
derived
Learn more about this trial
Short Versus Conventional Plaster Cast Fixation Time in Reduced Distal Radius Fractures
We'll reach out to this number within 24 hrs