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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00310570




Registration number
NCT00310570
Ethics application status
Date submitted
2/04/2006
Date registered
4/04/2006
Date last updated
4/04/2006

Titles & IDs
Public title
Comparison of Splinting Interventions for Treating Mallet Finger Injuries
Scientific title
Comparison of Splinting Interventions for Minimising Extensor Lag in Mallet Finger Injuries
Secondary ID [1] 0 0
Project 58/06
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mallet Finger 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Degree of extensor lag at distal inter-phalangeal (DIP)joint
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Active range of motion at DIP
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Patient compliance with splinting regime, based on self-report (as described above)
Timepoint [2] 0 0
Secondary outcome [3] 0 0
Patient satisfaction with result on 5-point likert scale
Timepoint [3] 0 0
Secondary outcome [4] 0 0
Complications
Timepoint [4] 0 0
Secondary outcome [5] 0 0
Pain, measured by 10 point Visual Analogue Scale
Timepoint [5] 0 0

Eligibility
Key inclusion criteria
- All referrals of patients with mallet finger injuries will be considered for inclusion with the exception of the following exclusion criteria.
Minimum age
16 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* open injuries
* mallet injury to thumb
* co-existing rheumatologic illness
* time from injury to presentation greater than 2 weeks

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Government body
Name
Bayside Health
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Lisa O'Brien, M.Clin.Sci
Address 0 0
The Alfred
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Richard Bloom, MBBS, FRACS
Address 0 0
Country 0 0
Phone 0 0
+613 9276 2000
Fax 0 0
Email 0 0
R.Bloom@alfred.org.au
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

TypeCitations or Other Details
Journal Handoll HH, Vaghela MV. Interventions for treating... [More Details]

Results not provided in https://clinicaltrials.gov/study/NCT00310570