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Trial registered on ANZCTR


Registration number
ACTRN12619001241123
Ethics application status
Approved
Date submitted
16/08/2019
Date registered
9/09/2019
Date last updated
9/09/2019
Date data sharing statement initially provided
9/09/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of TAM for two relative motion extension orthotic programs (RME full time v RME during the day and a night resting orthosis) following extensor tendon repair in zones V-VI: A randomised pilot study
Scientific title
Analysis of two relative motion extension orthotic programs in patients who have undergone extensor tendon repair in zones V-VI: A randomised pilot study
Secondary ID [1] 299049 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Extensor tendon repair in zones V and VI in the hand 314065 0
Condition category
Condition code
Musculoskeletal 312451 312451 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 312452 312452 0 0
Occupational therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The relative motion extension (RME) finger splint positions the injured metacarpophalangeal joint(s) in greater extension than the neighbouring uninjured metacarpophalangeal joint(s). This restricts motion in the repaired finger tendons to a safe range whilst allowing motion in the intact neighbouring fingers.
Within the first 10 days after surgery a one-on-one appointment is made with an Occupational Therapist (OT) or Physiotherapist (PT) working in the area of hand therapy with a minimum of 1 years experience in the specialty at the hand therapy clinic.
After randomization into one of the two treatment groups, the pre-selected splint(s) [RME or RME plus a night resting splint) will be fabricated by the treating therapist and participants will be asked to attend OT or PT (hand therapy) appointments as per standard postoperative care. Although the splint(s) are worn continuously for the first 4 weeks, patients are supervised in one-on-one therapy for exercise (active flexion and extension of the digits) and instruction to “wean” their use of the splints for 8 to 12 weeks postoperatively.Therapy sessions are booked for 15-30 minutes each (one-one-one) with frequency determined based on progress. It is not uncommon to have the initial session, followed by a review the following week, and then therapy sessions every 2-4 weeks thereafter depending on progress up to approximately 12 weeks after surgery. Outcomes measured during the therapy sessions include range of motion, grip strength, hand function, adherence via patient questionnaire and self-report, and satisfaction.
Intervention code [1] 315321 0
Rehabilitation
Intervention code [2] 315322 0
Treatment: Devices
Comparator / control treatment
The interventional group will wear the RME splint full time (24 hrs/day for 4 weeks) and the control group will wear the RME splint during the day and a larger forearm-hand-finger splint (resting splint) overnight for 4 weeks.
Control group
Active

Outcomes
Primary outcome [1] 321100 0
Active Range of motion (AROM): measured with a goniometer using a standard testing procedure.
Timepoint [1] 321100 0
Measured at 4, 8 and 12 weeks post-surgery.
Secondary outcome [1] 373990 0
Grip strength: measured using the average of three trials in a standard position using a digital hand dynamometer (Jamar),
Timepoint [1] 373990 0
Measured at 8 and 12 weeks post surgery.
Secondary outcome [2] 373991 0
Pain: Self-reported pain levels at rest and during activity measured as Part 1 on the Patient Rated Wrist/Hand Evaluation (PRWHE) questionnaire (MacDermid, 1996), composite secondary outcome.
Timepoint [2] 373991 0
Measured at 4, 8 and 12 weeks post surgery.
Secondary outcome [3] 373992 0
Hand function: Participant self-reported outcomes using the standardised tools: Part 2 of the PRWHE questionnaire and the Quick Disabilities of the Arm Shoulder and Hand (qDASH) questionnaire (Hudak, Amadio, & Bombardier, 1996).
Timepoint [3] 373992 0
Measured at 4, 8 and 12 weeks post-surgery.
Secondary outcome [4] 373993 0
Return to work / occupation: Participant self-report of time taken to return to modified/full or partial/full usual occupation, including paid/unpaid employment or usual homemaker or carer roles. The qDASH has a work and sports module to capture the impact of the injury on work and sports participation.
Timepoint [4] 373993 0
Measured at 4, 8 and 12 weeks post surgery.
Secondary outcome [5] 373995 0
Splint adherence: An adherence questionnaire to splint wearing with slight modification to the questionnaire (wording) asks participants six or eight questions (dependent on randomised group) about their hand use with and without the splint(s) during the first four postoperative weeks (Sandford, Barlow, & Lewis, 2008).
Timepoint [5] 373995 0
Completed at 4 weeks post surgery.
Secondary outcome [6] 373996 0
Overall satisfaction of hand therapy treatment and hand function: Patient evaluation measure (PEM) part 3, questionnaire (Dias, Bhowal, Wildin, & Thompson, 2001).
Timepoint [6] 373996 0
Measured at week 12 post surgery.
Secondary outcome [7] 373997 0
Hand appearance: Satisfaction with appearance of the hand is measured in the optional section of the PRWHE.
Timepoint [7] 373997 0
Measured at 4, 8 and 12 weeks post surgery.
Secondary outcome [8] 373998 0
Adverse events: Development of wound infection, dehiscence, tendon rupture, unusual hand pain/oedema (Chronic regional pain syndrome) via clinical examination or as reported by the patient.
Timepoint [8] 373998 0
Recorded during the study period (until patient discharge from therapy).
Secondary outcome [9] 373999 0
Number of hand therapy sessions: number attended plus any failed to attend recorded for the participants hand therapy treatment period as recorded in the patient notes.
Timepoint [9] 373999 0
Measured at the time of therapy discharge.

Eligibility
Key inclusion criteria
Zone V and/or VI EDC and/or EIP and/or EDM 50-100% tendon laceration with repair
The surgeon or surgical team member has deemed the repair suitable for early mobilisation (i.e. repair not tight or fragile, no unrepaired partial tendon lacerations)
Repair of 3 or fewer fingers
10 or fewer days since surgical repair of the tendon(s)
With or without MCP joint capsular repair
Hand fractures assessed by the surgeon or surgical team member as appropriate for early active motion
Adult (aged 18 or over)
Ability to give written consent and to participate in English
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Repair to 4 fingers
Repair to extensor pollicis longus
Concomitant flexor tendon repair
Tenuous tendon repair as assessed by the surgeon or surgical team member
Hand fractures deemed unsuitable for early active motion as assessed by the surgeon or surgical team member
Inability to give informed consent
Unable to understand English
Has a condition that will hinder the participant’s ability to comply with the study protocol (e.g. cognitive impairment)
Has a condition that may hinder healing (e.g. Diabetes, undergoing cancer treatment)

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation sequence generation using Sealed Envelope Limited statistical software (Sealed Envelope Ltd., 2017) created for each participating centre using random block sizes of 2, 4, and 6.


Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
7/03/2019
Date of last participant enrolment
Anticipated
31/03/2020
Actual
Date of last data collection
Anticipated
30/06/2020
Actual
Sample size
Target
32
Accrual to date
5
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 14570 0
Austin Health - Heidelberg Repatriation Hospital - Heidelberg West
Recruitment hospital [2] 14571 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [3] 14572 0
Dandenong Hospital - Dandenong
Recruitment hospital [4] 14574 0
Western Hospital - Footscray - Footscray
Recruitment hospital [5] 14657 0
Malvern Hand Therapy - Malvern
Recruitment postcode(s) [1] 27590 0
3081 - Heidelberg West
Recruitment postcode(s) [2] 27591 0
3050 - Parkville
Recruitment postcode(s) [3] 27592 0
3175 - Dandenong
Recruitment postcode(s) [4] 27594 0
3011 - Footscray
Recruitment postcode(s) [5] 27686 0
3144 - Malvern

Funding & Sponsors
Funding source category [1] 303585 0
Charities/Societies/Foundations
Name [1] 303585 0
Australian Hand Therapy Association (AHTA) research grant
Country [1] 303585 0
Australia
Primary sponsor type
Hospital
Name
Austin Health
Address
Occupational Therapy Department
Studley Road
Heidelberg, VIC 3084
Country
Australia
Secondary sponsor category [1] 303669 0
University
Name [1] 303669 0
Monash University
Address [1] 303669 0
Department of Occupational Therapy
Monash University
McMahon's Road
Frankston, VIC 3199
Country [1] 303669 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304113 0
Austin Health Human Research Ethics Research Committee
Ethics committee address [1] 304113 0
Ethics committee country [1] 304113 0
Australia
Date submitted for ethics approval [1] 304113 0
31/10/2018
Approval date [1] 304113 0
19/12/2018
Ethics approval number [1] 304113 0
HREC/46619/Austin-2018

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

Contacts
Principal investigator
Name 95854 0
Ms Melissa Hirth
Address 95854 0
Occupational Therapy Department
Austin Health - Repatriation Campus
190 Banksia Street
Heidelberg West, VIC 3081
Country 95854 0
Australia
Phone 95854 0
+61 03 9496 2197
Fax 95854 0
Email 95854 0
melissa.hirth@austin.org.au
Contact person for public queries
Name 95855 0
Melissa Hirth
Address 95855 0
Occupational Therapy Department
Austin Health - Repatriation Campus
190 Banksia Street
Heidelberg West, VIC 3081
Country 95855 0
Australia
Phone 95855 0
+61 03 9496 2197
Fax 95855 0
Email 95855 0
melissa.hirth@austin.org.au
Contact person for scientific queries
Name 95856 0
Melissa Hirth
Address 95856 0
Occupational Therapy Department
Austin Health - Repatriation Campus
190 Banksia Street
Heidelberg West, VIC 3081
Country 95856 0
Australia
Phone 95856 0
+61 03 9496 2197
Fax 95856 0
Email 95856 0
melissa.hirth@austin.org.au

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.