Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12612001238864
Ethics application status
Approved
Date submitted
16/11/2012
Date registered
23/11/2012
Date last updated
14/03/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Can splinting and early mobilization in the dart-throwers plane of motion improve functional outcomes and reduce postoperative complications in people after scapho-lunate ligament repairs? (Pilot Study)
Scientific title
Can splinting and early mobilization in the dart-throwers plane of motion improve functional outcomes and reduce postoperative complications in people after scapho-lunate ligament repairs? (Pilot Study)
Secondary ID [1] 281557 0
n/a
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
scapho-lunate ligament injury 287838 0
Condition category
Condition code
Injuries and Accidents 288181 288181 0 0
Other injuries and accidents
Musculoskeletal 288214 288214 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
When the surgeon decides it is safe to remove the post-operative plaster cast (usually at 6 weeks, but can vary from 4-10 weeks depending on complexity of surgery) participants are randomised to 2 groups: intervention and control.

For the intervention group, a 2-part hinged splint will be fabricated which allows wrist motion in the Dart Throwing Plane. This is the normal motion the wrist would go through when thowing a dart or using a hammer, and involves a comination side-to-side and flexion / extension.

The splint is to be removed only for hygiene and for exercise program every 2 hours during the day for the first 4 weeks, beginning with:
- gentle wrist movement within patient's pain limits: wrist in mid-prone extension and flexion (no flexion beyond 30 degrees); wrist in supination ulnar and radial deviation; tenodesis exercise; dart-throw motion. These will be taught in the clinic, with correction of technique if necessary, then the participant continues the program at home. Participants are reviewed weekly to check progress until week 6.

After first week:
- add gentle isometric activation of flexor carpi radialis
After third week:
- add gentle isometric activation of: flexor carpi ulnaris, abductor pollicis longus, extensor carpi radialis longus and brevis.

After 4 weeks, the splint can be removed for light activity (e.g. dressing, grooming, eating) but should be worn if pain flares or when doing more strenuous tasks. It should cease completely by week 6.
Intervention code [1] 286073 0
Rehabilitation
Intervention code [2] 286097 0
Treatment: Other
Comparator / control treatment
Static splint which allows no wrist motion. This is custom fabricated at 4-10 weeks post surgery, and is to be removed only for hygiene and exercise program every 2 hours as described above for 4 weeks.

After 4 weeks, the splint can be removed for light activity (e.g. dressing, grooming, eating) but should be worn if pain flares or when doing more strenuous tasks. It should cease completely by week 6.
Control group
Active

Outcomes
Primary outcome [1] 288382 0
Pain (as measured on Patient rated wrist and hand evaluation)
Timepoint [1] 288382 0
12 weeks post commencement of treatment
Secondary outcome [1] 300004 0
Function (as measured on Patient rated wrist and hand evaluation)
Timepoint [1] 300004 0
12 weeks post commencement of treatment
Secondary outcome [2] 300077 0
Time taken to return to usual activities (including self-care, work and recreation)
Timepoint [2] 300077 0
Weekly up until 12 weeks
Secondary outcome [3] 300078 0
whether a larger trial is feasible
Timepoint [3] 300078 0
on completion of recruitment of 20 participants, and analysis of final results

Eligibility
Key inclusion criteria
All people who have had surgery to repair the scapho-lunate ligament in the previous 8 weeks
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- significant other injuries to the same limb,
- co-existing rheumatological illness,
- if they (or their carer / guardian) are not able to provide informed consent, or
- if they are not able to speak or comprehend the English language.

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)
Those agreeing to enrol will have an appointment scheduled with one of the senior hand therapists when their plaster cast is removed after surgical review and written informed consent will be obtained when they attend this appointment. Group information will be contained in opaque, consecutively numbered sealed envelopes prepared by the research supervisor.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocated according to a randomised computer sequence.
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
Recruiting
Date of first participant enrolment
Anticipated
11/01/2012
Actual
11/01/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 286339 0
Hospital
Name [1] 286339 0
The Alfred Small Project Grants
Country [1] 286339 0
Australia
Primary sponsor type
Hospital
Name
The Alfred
Address
55 Commercial Rd
Melbourne 3004
Victoria
Country
Australia
Secondary sponsor category [1] 285131 0
None
Name [1] 285131 0
Address [1] 285131 0
Country [1] 285131 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288416 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 288416 0
55 Commercial Rd
Melbourne 3004
Victoria
Ethics committee country [1] 288416 0
Australia
Date submitted for ethics approval [1] 288416 0
Approval date [1] 288416 0
08/09/2011
Ethics approval number [1] 288416 0
1/11/0206

Summary
Brief summary
Research Question:

Does splinting and early mobilization in the dart-throwers plane of motion improve functional outcomes and reduce postoperative complications in people after scapho-lunate ligament repairs?

Hypothesis:

A dynamic splint configured to allow motion only in the dart thrower’s plane applied after plaster cast removal (this is determined by the surgeon according to operative technique, and is usually 6 weeks post surgery, but can be 4-10 weeks post surgery)will result in faster return to usual activities (including self-care, work and recreation) better patient ratings of function, less pain, and less post-operative complications than a static splint.

Aim/s:

To compare outcomes between two groups of patients – one of whom received the dynamic splint, the other the static splint at 12 weeks post scapho-lunate ligament repair - to determine whether patients recover more quickly, and rate their function and pain differently; and

To see if a larger multi-centre study is feasible.

Both groups will be advised that splints are to be removed only for hygiene and 2 hourly exercise program for 4 weeks, after which time it is phased out over the following 2 weeks. This means it is taken off for light activity at first, then ceased altogether.
Trial website
n/a
Trial related presentations / publications
n/a
Public notes

Contacts
Principal investigator
Name 34964 0
Dr Lisa O'Brien
Address 34964 0
Occupational Therapy Department
The Alfred
55 Commercial Rd
Melbourne 3004
Victoria
Country 34964 0
Australia
Phone 34964 0
+61390763526
Fax 34964 0
Email 34964 0
[email protected]
Contact person for public queries
Name 18211 0
Sharon Goldby
Address 18211 0
Occupational Therapy
The Alfred
55 Commercial Rd
Melbourne 3004
Victoria
Country 18211 0
Australia
Phone 18211 0
+61390763526
Fax 18211 0
+61390762920
Email 18211 0
[email protected]
Contact person for scientific queries
Name 9139 0
Sharon Goldby
Address 9139 0
Occupational Therapy
The Alfred
55 Commercial Rd
Melbourne 3004
Victoria
Country 9139 0
Australia
Phone 9139 0
+61390763526
Fax 9139 0
+61390762920
Email 9139 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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.