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Trial registered on ANZCTR


Registration number
ACTRN12610000527066
Ethics application status
Approved
Date submitted
23/06/2010
Date registered
25/06/2010
Date last updated
11/08/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of splinting post Dupuytren’s contracture release
Scientific title
Effectiveness of splinting for improving finger range of motion and function post Dupuytren’s contracture release
Secondary ID [1] 252089 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dupuytren's Contracture 257634 0
Condition category
Condition code
Physical Medicine / Rehabilitation 257812 257812 0 0
Occupational therapy
Musculoskeletal 257829 257829 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Night extension splinting for three months post operatively.
Intervention code [1] 256711 0
Rehabilitation
Comparator / control treatment
No post surgery splinting.
Control group
Active

Outcomes
Primary outcome [1] 258672 0
Post surgery range of motion measured by the combination of metacarpophalangeal joint (MCPJ) and proximal interphalangeal joint (PIPJ) extension of the little finger using a standard finger goniometer
Timepoint [1] 258672 0
3 months post surgery.
Secondary outcome [1] 264668 0
*total active flexion of the operated fingers - measured using a finger goniometer
Timepoint [1] 264668 0
6 weeks and 3 months post surgery.
Secondary outcome [2] 264669 0
*composite finger flexion measured in centimeters from the distal palmar crease to the mail fold of the finger..
Timepoint [2] 264669 0
6 weeks and 3 months post surgery.
Secondary outcome [3] 264670 0
* grip strength - measured using a Jamar dynamometer
Timepoint [3] 264670 0
6 weeks and 3 months post surgery
Secondary outcome [4] 326689 0
*hand function - measured using the Disabilities of Arm, Shoulder and Hand (DASH) validated questionnaire.
Timepoint [4] 326689 0
6 weeks and 3 months post surgery

Eligibility
Key inclusion criteria
Dupuytren's Contracture Release (DCR) on one or more fingers.
Attended hand therapy within 10 days of DCR
Minimum age
18 Years
Maximum age
95 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patient not attending 2 or more consecutive hand therapy appointments
K-wiring of PIP joint intra-operatively.

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)
Randomisation will be done by selecting a random envelope with group allocation concealed in it
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2010
Actual
20/09/2010
Date of last participant enrolment
Anticipated
1/07/2011
Actual
14/07/2011
Date of last data collection
Anticipated
1/10/2011
Actual
22/11/2011
Sample size
Target
49
Accrual to date
Final
56
Recruitment outside Australia
Country [1] 2721 0
New Zealand
State/province [1] 2721 0

Funding & Sponsors
Funding source category [1] 257180 0
Charities/Societies/Foundations
Name [1] 257180 0
Centre for Clinical Research & effective practice (CCRep)
Country [1] 257180 0
New Zealand
Primary sponsor type
Charities/Societies/Foundations
Name
Centre for Clinical Research & effective practice (CCRep)
Address
Private Bag 93311
Otahuhu
Auckland 1640
Country
New Zealand
Secondary sponsor category [1] 256437 0
None
Name [1] 256437 0
Address [1] 256437 0
Country [1] 256437 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259218 0
Northern Y Ethics Committee
Ethics committee address [1] 259218 0
3rd floor, BNZ building
354 Victoria St
PO Box 1031
Hamilton 3204
Ethics committee country [1] 259218 0
New Zealand
Date submitted for ethics approval [1] 259218 0
28/06/2010
Approval date [1] 259218 0
20/07/2007
Ethics approval number [1] 259218 0
NTX/10/07/07

Summary
Brief summary
This randomised controlled trial will evaluate the clinical outcomes from a group of patients post Dupuytren’s contracture surgery that have two different management programmes.

The aim of the study is to determine the effect of splinting or not splinting following release of Dupuytren’s contracture on finger range of movement and function.
Trial website
www.ccrep.org.nz
Trial related presentations / publications
The Effect of Night Extension Orthoses Following Surgical Release of Dupuytren Contracture: A Single- Center, Randomized, Controlled Trial.

Julie Collis, MSc (Hons), Shirley Collocott, BSc, Wayne Hing, PhD, Edel Kelly, MSc (Hons)
J Hand Surg 2013;38A:1285–1294
Public notes

Contacts
Principal investigator
Name 31330 0
Ms Shirley Collocott
Address 31330 0
Manukau SuperClinic, CMDHB Private Bag 93311 Otahuhu Auckland 1640
Country 31330 0
New Zealand
Phone 31330 0
+64 2760044 Ext 8684
Fax 31330 0
Email 31330 0
[email protected]
Contact person for public queries
Name 14577 0
Ms Shirley Collocott
Address 14577 0
Manukau SuperClinic, CMDHB
Private Bag 93311
Otahuhu
Auckland 1640
Country 14577 0
New Zealand
Phone 14577 0
+64 9 250 8053 extn 4783
Fax 14577 0
Email 14577 0
[email protected]
Contact person for scientific queries
Name 5505 0
Ms Shirley Collocott
Address 5505 0
Manukau SuperClinic, CMDHB
Private Bag 93311
Otahuhu
Auckland 1640
Country 5505 0
New Zealand
Phone 5505 0
+64 9 250 8053 extn 4783
Fax 5505 0
Email 5505 0
[email protected]

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

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