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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
Stubbing of the finger-tip is a common injury in sports such as basketball, volleyball, cricket and football. This can result in a Mallet finger deformity, where the end joint of a finger cannot be actively straightened out. In most mallet finger cases seen at The Alfred, the skin remains intact, and the impairment results from a tear of the extensor tendon or an avulsion (a small fracture where the tendon attaches to the bone). Treatment commonly involves immobilising the end joint of the finger in a splint for six or more weeks so patient compliance is a major factor in the quality of the outcome achieved.

This study aims to compare two different types of splintage (the commonly used thermoplastic thimble splint and the aluminium-foam "Mexican hat" splint which is in use in Britain) with a control splint (thermoplastic prefabricated "stack splint" with tape). Outcome measures will include patient compliance with the splint, degree of extensor lag, active movement of the joint, and any complications.

The null hypothesis is that there are no differences in outcome between different methods of conservative splinting treatment for mallet finger.
Trial website
https://clinicaltrials.gov/study/NCT00310570
Trial related presentations / publications
Wilson SW, Khoo CT. The Mexican hat splint--a new splint for the treatment of closed mallet finger. J Hand Surg Br. 2001 Oct;26(5):488-9. doi: 10.1054/jhsb.2001.0590.
Handoll HH, Vaghela MV. Interventions for treating mallet finger injuries. Cochrane Database Syst Rev. 2004;(3):CD004574. doi: 10.1002/14651858.CD004574.pub2.
O'Brien LJ, Bailey MJ. Single blind, prospective, randomized controlled trial comparing dorsal aluminum and custom thermoplastic splints to stack splint for acute mallet finger. Arch Phys Med Rehabil. 2011 Feb;92(2):191-8. doi: 10.1016/j.apmr.2010.10.035.
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
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00310570