Short Versus Conventional Plaster Cast Fixation Time in Reduced Distal Radius Fractures
GitRa
A Comparison of Radiographic and Clinical Results After Short Versus Conventional Plaster Cast Fixation Time in Reduced Distal Radius Fractures
1 other identifier
interventional
109
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2002
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
June 1, 2016
CompletedFirst Posted
Study publicly available on registry
June 14, 2016
CompletedJune 16, 2016
June 1, 2016
7.3 years
June 1, 2016
June 14, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Radiographic displacement
Change in dorsal angulation, radial angulation and axial compression between follow-ups.
At admission, 10 days, 1 month and 12 months
Secondary Outcomes (4)
Grip strength
Uninjured side. Injured side at 1, 4 , 12 months
Range of motion
Uninjured side. Injured side at 1, 4 and 12 months
Assessment of pain intensity
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.
12 months
Study Arms (2)
10-day cast
ACTIVE COMPARATORRemoval of plaster cast 10 Days after reduction
1-month cast
NO INTERVENTIONRemoval of plaster cast 1 month after reduction
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Fracture older than 3 Days
- Previously fractured ipsi- or contralateral wrist
- Dementia
- Inflammatory joint disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 27871284DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Albert Christersson, MD
Department of Orthopaedics, University Hospital of Uppsala
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
June 1, 2016
First Posted
June 14, 2016
Study Start
September 1, 2002
Primary Completion
January 1, 2010
Study Completion
January 1, 2010
Last Updated
June 16, 2016
Record last verified: 2016-06
Data Sharing
- IPD Sharing
- Will not share