Trial Review

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
ACTRN12618001899235
Ethics application status
Approved
Date submitted
5/11/2018
Date registered
22/11/2018
Date last updated
22/11/2018
Date data sharing statement initially provided
22/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A prospective audit of the outcomes of patients with finger flexor tendon repairs managed with an early active motion program at the Royal Adelaide Hospital (RAH)
Scientific title
A prospective audit of the outcomes of patients with finger flexor tendon repairs managed with an early active motion program at the Royal Adelaide Hospital (RAH)
Secondary ID [1] 296641 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Flexor tendon injury 309698 0
Condition category
Condition code
Injuries and Accidents 308503 308503 0 0
Other injuries and accidents
Physical Medicine / Rehabilitation 309180 309180 0 0
Physiotherapy

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Isolated finger flexor tendon repairs will be assessed and managed by physiotherapy at the Royal Adelaide Hospital for a period of three months post surgical repair. Patients will participate in early motion protocol which consists of controlled range of motion exercises in an orthosis for 6 weeks and progression of exercises out of splint, followed by strengthening for the following 6 weeks post-operatively.
Intervention code [1] 312447 0
Not applicable
Comparator / control treatment
no control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 307480 0
Active Range of Motion measured with a goniometer
Timepoint [1] 307480 0
Weekly the first 6 weeks, then fortnightly until 12 weeks. primary timepoint 12 weeks
Primary outcome [2] 307502 0
Grip Strength- Jamar dynamometer Position 2
Timepoint [2] 307502 0
12 weeks post operation
Primary outcome [3] 307503 0
Michigan Hand Questionaire
Timepoint [3] 307503 0
Week 1, 6, 8, 10 and 12 post-operation. primary timepoint 12 weeks.
Secondary outcome [1] 352086 0
Pain- visual analogue scale
Timepoint [1] 352086 0
weekly for first 6 weeks and then 8 weeks, 10 weeks and 12 weeks.
Secondary outcome [2] 352087 0
Return to Work timeframe. subjectively discussed with patient.
Timepoint [2] 352087 0
asked weekly at appointments for first 6 weeks, then at 8, 10 and 12 weeks

Eligibility
Key inclusion criteria
-Patients admitted to the RAH (Royal Adelaide Hospital) with an isolated finger flexor tendon injury requiring surgical repair, managed post-operatively with an early active motion program.
-Patients that live in metropolitan Adelaide and can attend the RAH for follow up therapy ---Patients that live in the country who can complete questionnaires and attend the multidisciplinary clinic for follow up
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
-Are aged less than 18 years
-Refuse consent
-Have a limited ability to read or understand English
-Have a thumb flexor tendon injury
-Have associated injuries such as fractures, extensor tendon or peripheral nerve injuries
-Have had other major trauma injuries at admission to hospital (eg major bony fracture)
-Indicate that they would not be able to return to the RAH for any follow-up appointments
-Were initially treated for their injury at another hospital and their transfer to the RAH only occurred after two weeks or more
-Have received their injury in circumstances that were considered so traumatic (eg self-inflicted injury) that a request to consider participating in the study would be inappropriate.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Outcome measure data will be input into a password protected Excel Spreadsheet. Aggregated data will not contain patient identifiers. Statistical analyses will be performed using the SPSS Graduate Pack. Repeated measures analysis of variance will be used to analyse outcomes over time. This audit will allow identification of outcomes following isolated finger flexor tendon repairs managed with an early active motion program at the RAH. This information will allow for the establishment of expected patterns and time frames for recovery in patients with finger flexor tendon injuries. It will identify the most appropriate outcome measures for use in routine practice in this cohort of patients. It may also be possible to compare outcomes of RAH patients with those from other services within Australia and internationally.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2018
Actual
Date of last participant enrolment
Anticipated
11/09/2020
Actual
Date of last data collection
Anticipated
13/12/2020
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 12302 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 24496 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 300709 0
Hospital
Name [1] 300709 0
Royal Adelaide Hospital
Country [1] 300709 0
Australia
Primary sponsor type
Individual
Name
Madelaine Carey
Address
Royal Adelaide Hospital, Port Road, Adelaide, South Australia, 5000
Country
Australia
Secondary sponsor category [1] 300242 0
Individual
Name [1] 300242 0
Nicola Williams
Address [1] 300242 0
Royal Adelaide Hospital, Port Road, Adelaide, South Australia, 5000
Country [1] 300242 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301492 0
Central Adelaide Local Health Network (CALHN) Human Research Ethics Committee
Ethics committee address [1] 301492 0
Level 3 Roma Mitchell House
136 North Terrace Adelaide SA 5000
Ethics committee country [1] 301492 0
Australia
Date submitted for ethics approval [1] 301492 0
28/08/2018
Approval date [1] 301492 0
29/08/2018
Ethics approval number [1] 301492 0
R20180822

Summary
Brief summary
PURPOSE OF STUDY
To establish the outcomes of patients with finger flexor tendon repairs managed with an early active motion program at the Royal Adelaide Hospital (RAH).
The specific aims of the study are to:
• Gather baseline information for patients with isolated finger flexor tendon repairs.
• Establish inter-rater reliability in assessment methods used to enable more than one rater to be involved.
• Collect outcome measures for patients managed with an early active motion program for a period of 3 months.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 87182 0
Ms Madelaine Carey
Address 87182 0
Royal Adelaide Hospital, Port Road, Adelaide, South Australia, 5000
Country 87182 0
Australia
Phone 87182 0
+61 8 70744000
Fax 87182 0
Email 87182 0
[email protected]
Contact person for public queries
Name 87183 0
Ms Madelaine Carey
Address 87183 0
Royal Adelaide Hospital, Port Road, Adelaide, South Australia, 5000
Country 87183 0
Australia
Phone 87183 0
+61 8 70744000
Fax 87183 0
Email 87183 0
[email protected]
Contact person for scientific queries
Name 87184 0
Ms Madelaine Carey
Address 87184 0
Royal Adelaide Hospital, Port Road, Adelaide, South Australia, 5000
Country 87184 0
Australia
Phone 87184 0
+61 8 70744000
Fax 87184 0
Email 87184 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.