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Trial registered on ANZCTR


Registration number
ACTRN12615000425594
Ethics application status
Approved
Date submitted
25/03/2015
Date registered
5/05/2015
Date last updated
10/07/2019
Date data sharing statement initially provided
10/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomised controlled trial of splinting methods for rehabilitation of extensor tendon repair
Scientific title
Is relative motion extension splinting non-inferior for total active motion and more cost-effective compared to dynamic extension splinting for extensor tendon repair in zone V and VI: A randomised controlled trial.
Secondary ID [1] 286398 0
Nil known
Universal Trial Number (UTN)
U1111-1167-6018
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 294551 0
Condition category
Condition code
Musculoskeletal 294860 294860 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 294966 294966 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Relative motion extension (RME) splinting employs two components; a volar static wrist extension orthosis and a digital orthosis in the manner of a ‘yoke’.
Within the first 10 days post-surgery a Hand Therapy appointment is arranged and administered with a Physiotherapist or Occupational Therapist with 3 years or more Hand Therapy training, and the RME digital and wrist orthoses (splints) along with a resting pan night splint are fitted. The resting pan splint is worn every night throughout the 8-9 week intervention period.
During Week 1-3 the RME digital splint and the wrist splint are worn together during waking hours. Participants are instructed to actively flex and extend their fingers as far as they can within the confines of the day time splints 10-20 times every 2 hours and use their hand for light functional activities.
During Week 4-5 digital splinting and mobilisation continues as for Week 1-3, however participants are instructed to remove the wrist component only and mobilise the wrist from extension to flexion in a tenodesis pattern 10 times every two hours. When full wrist range of motion is achieved, the wrist orthosis is discontinued for most of the time and only worn for heavy activity.
Week 6-9: Participants are instructed to wear the finger component only during activity, and to remove the orthosis for active finger flexion and extension 10 times every hour.
When full finger (active) range of motion is achieved, the finger orthosis is discontinued.

In order to optimise retention and adherence to intervention protocols, participants will be provided with petrol vouchers in recognition of the costs of attending the two follow-up assessments. Petrol vouchers will be provided at the rate of $20 for each assessment attended. In addition, for participants who live more than 20 km from the study locality and the follow-up assessment does not coincide with a follow-up Hand Therapy or Surgical appointment (and the participant is not eligible for Accident Compensation Corporation travel costs), petrol vouchers will be provided at the rate of 50c per km travelled.

Adherence to splinting will be evaluated using a participant questionnaire completed retrospectively at 6-weeks.
Intervention code [1] 291467 0
Treatment: Devices
Intervention code [2] 291482 0
Treatment: Other
Intervention code [3] 291563 0
Rehabilitation
Comparator / control treatment
Dynamic extension splinting employs a dynamic forearm based orthosis to allow early digital motion while protecting the repaired extensor tendons.
Within the first 10 days post-surgery a Hand Therapy appointment is arranged and administered with a Physiotherapist or Occupational Therapist with 3 years or more Hand Therapy training, and the dynamic extensor splint (wrist in 30 degrees extension; injured digit and adjacent MCP joints rest in neutral) and pan resting splint are fitted. The resting pan splint is worn every night throughout the 8 week intervention period.
During Week 1-3 the dynamic extensor splint is worn during waking hours. Participants are instructed to 1) actively flex the finger at the MCP joints 30-40 degrees, allowing the extensor outrigger to passively return the MCP joints to 0 degrees and 2) flex and extend the IP joints as far as comfortable within the confines of the splint. Participants are instructed to perform the exercises 10-20 times each waking hour.
During Week 4-5, exercise 1) above is progressed by 10-20 degrees per week, unless an extensor lag appears. Participants are also instructed to remove the dynamic extensor splint every 2 hours to actively flex and extend the IP joints as far as comfortable and to mobilise the wrist from neutral to extension in a tenodesis pattern. Participants are instructed to perform the exercises 10-20 times each waking hour.
Week 6-8: The dynamic extensor splint is discontinued.

Measures to optimise retention and evaluate adherence as above.
Control group
Active

Outcomes
Primary outcome [1] 294627 0
The primary outcome measure is digital range of motion as measured using a metal finger goniometer and calculating total active motion (TAM) ([active flexion of MCP + PIP + DIP] – [extension lag of MCP + PIP + DIP]) (Kleinert 1983)
Timepoint [1] 294627 0
6 and 12 weeks post surgery
Secondary outcome [1] 313743 0
Patient-reported function (Quick Disabilities of the Arm, Shoulder and Hand, QuickDASH)
Timepoint [1] 313743 0
6 and 12 weeks post surgery
Secondary outcome [2] 313744 0
Grip strength (JAMAR dynamometer)
Timepoint [2] 313744 0
12 weeks post surgery
Secondary outcome [3] 313745 0
Return to ordinary or modified work (paid or un-paid) (participant return to work questionnaire)
Timepoint [3] 313745 0
6 and 12 weeks post surgery
Secondary outcome [4] 313746 0
Patient-reported satisfaction (Satisfaction with Splinting, Treatment and Outcome questionnaire)
Timepoint [4] 313746 0
6 and 12 weeks
Secondary outcome [5] 313747 0
Patient adherence (Adherence to Splinting questionnaire) (modified from Sandford et al. 2008)
Timepoint [5] 313747 0
6 weeks post surgery
Secondary outcome [6] 313748 0
Complications and further surgery (as recorded in medical records and reported by participant)
Timepoint [6] 313748 0
12 weeks post surgery
Secondary outcome [7] 313749 0
Self-reported direct costs (Participant Questionnaire) (modified from Van den Brink 2005)
Timepoint [7] 313749 0
6 and 12 weeks post surgery
Secondary outcome [8] 313750 0
Direct costs - Hospital medical records (Data collection sheet)
Timepoint [8] 313750 0
12 weeks post surgery
Secondary outcome [9] 313751 0
Patient-reported health status (EuroQuol-5D-3L, EQ-5D-3L) (The EuroQol Group 1990) index value
Timepoint [9] 313751 0
6 and 12 weeks post surgery

Eligibility
Key inclusion criteria
*Patients undergoing primary repair of the extensor tendon in zones V and/or VI of one or more digits at Dunedin Hospital.
*Simple division of 50% to 100% of the tendon as determined intra-operatively by the surgeon
*Surgical repair suitable for early mobilisation.
*Able to provide written informed consent.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
*Complex multi-tissue injury e.g. unstable fracture; significant skin loss; concurrent flexor tendon repair; replantation or revascularisation.
*Extensor tendon repair to more than three digits
*Extensor tendon repair to the thumb
*Age under 16 years
*Co-existing rheumatologic illness
*Individual factors such as inability to adhere to the intervention or significant co-morbidity.

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)
Group allocation is concealed in a sealed opaque envelope until after completion of the enrolment and consent process, at which time group allocation will be revealed and the treating Hand Therapist notified of the participant's treatment group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software will be used to generate the sequence in which subjects will be randomised. The randomisation schedule is prepared by Co-investigator (HA) and concealed in opaque envelopes opened in sequence.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Pragmatic, assessor blinded and partial participant blinded parallel-group non-inferiority RCT.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A clinically significant difference for TAM has not been established in the literature. A trial by Mowlavi et al (2005) found a statistically significant difference of 16% at 6 weeks between dynamic extension splinting (239 +/- 22) and immobilization (206 +/- 53). This is plausably a clinically significant difference as immobilization is assumed to be an inferior treatment compared with either splinting option, thus is appropriate for use as an inferiority boundary. Assuming 16% difference in TAM is clinically significant, this requires a sample size of 17 participants per group to give 90% power using 1-sided p-values significant at the 5% level, appropriate for a primary non-inferiority and secondary superiority research question (Haynes 2006). This is a conservative estimate, as immobilization typically has greater variability (SD) than either splinting option. Allowing for a plausible drop-out of 20%, this equates to 19 participants in each group or a total of 38 participants.
Participant characteristic variables will be presented to assess the baseline comparability of the two groups. Descriptive statistics will be presented for each group with the mean value (standard deviation, 95% confidence interval) for outcomes at each time point. As the outcome of multiple extensor tendon repairs in one hand cannot be considered as independent observations, the mean TAM scores for patients (rather than for individual digits) will be calculated and compared between the two groups. Differences in mean values between groups will be compared using regression analysis, carried out at the 5% level of significance. Primary analysis of the data will follow the intention to treat principle and will include all participants, including those who have missing data and who are not fully adherent to the protocol. The handling of missing data will be through the use of the multiple imputation method.
Cost analysis will include both health system and societal resource costs. The primary economic evaluation will be a cost-utility analysis based on EQ-5D-3L score index value.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
25/05/2015
Actual
25/05/2015
Date of last participant enrolment
Anticipated
31/12/2018
Actual
18/02/2019
Date of last data collection
Anticipated
31/03/2019
Actual
15/05/2019
Sample size
Target
38
Accrual to date
Final
38
Recruitment outside Australia
Country [1] 6771 0
New Zealand
State/province [1] 6771 0
Otago-Southland

Funding & Sponsors
Funding source category [1] 290980 0
Charities/Societies/Foundations
Name [1] 290980 0
Healthcare Otago Charitable Trust
Country [1] 290980 0
New Zealand
Funding source category [2] 290981 0
Charities/Societies/Foundations
Name [2] 290981 0
New Zealand Association of Hand Therapists
Country [2] 290981 0
New Zealand
Primary sponsor type
Individual
Name
Miranda Buhler
Address
Physiotherapy Outpatient Department
Dunedin Hospital
Southern District Health Board
Private Bat 1921
Dunedin 9054
Country
New Zealand
Secondary sponsor category [1] 289660 0
Individual
Name [1] 289660 0
Associate Professor J. Haxby Abbott
Address [1] 289660 0
Dunedin School of Medicine
PO Box 56
Dunedin 9054
Country [1] 289660 0
New Zealand
Secondary sponsor category [2] 289661 0
Individual
Name [2] 289661 0
Associate Professor David Gwynne-Jones
Address [2] 289661 0
Dunedin School of Medicine
PO Box 56
Dunedin 9054
Country [2] 289661 0
New Zealand
Secondary sponsor category [3] 289662 0
Individual
Name [3] 289662 0
Mr Michael Chin
Address [3] 289662 0
Orthopaedic Service
Dunedin Hospital
Southern District Health Board
Private Bag 1921
Dunedin 9054
Country [3] 289662 0
New Zealand
Secondary sponsor category [4] 289663 0
Individual
Name [4] 289663 0
Mr Joshua Woodside
Address [4] 289663 0
Physiotherapy Outpatient Department
Dunedin Hospital
Southern District Health Board
Private Bag 1921
Dunedin 9054
Country [4] 289663 0
New Zealand
Secondary sponsor category [5] 299792 0
Individual
Name [5] 299792 0
Mr Jamie Gough
Address [5] 299792 0
Physiotherapy Outpatient Department Dunedin Hospital Southern District Health Board Private Bag 1921 Dunedin 9054
Country [5] 299792 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292572 0
Health and Disability Ethics Committee
Ethics committee address [1] 292572 0
Ethics committee country [1] 292572 0
New Zealand
Date submitted for ethics approval [1] 292572 0
25/03/2015
Approval date [1] 292572 0
06/05/2015
Ethics approval number [1] 292572 0
15/STH/63

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 365 365 0 0
/AnzctrAttachments/368224-Extensor Tendon Study Protocol_v5.pdf
Attachments [2] 367 367 0 0
/AnzctrAttachments/368224-Appendix 2 Guidelines for study clinicians_v2.pdf
Attachments [3] 368 368 0 0
/AnzctrAttachments/368224-Appendix 4 Questionnaire RTW.pdf
Attachments [4] 369 369 0 0
/AnzctrAttachments/368224-Appendix 5 Questionnaire Satisfaction.pdf
Attachments [5] 370 370 0 0
/AnzctrAttachments/368224-Appendix 6 Questionnaire Adherence to Splinting.pdf
Attachments [6] 373 373 0 0
/AnzctrAttachments/368224(v25-03-2015-10-13-30)-Appendix 8 Questionnaire Costs Patient.pdf
Attachments [7] 1572 1572 0 0
/AnzctrAttachments/368224-Appendix 1 Information Consent Form_v5.pdf

Contacts
Principal investigator
Name 55954 0
Ms Miranda Buhler
Address 55954 0
Physiotherapy Outpatient Department
Dunedin Hospital
Southern District Health Board
Private Bag 1921
Dunedin 9054
Country 55954 0
New Zealand
Phone 55954 0
64 3 4709347
Fax 55954 0
64 3 4709221
Email 55954 0
miranda.buhler@southerndhb.govt.nz
Contact person for public queries
Name 55955 0
Miranda Buhler
Address 55955 0
Physiotherapy Outpatient Department
Dunedin Hospital
Southern District Health Board
Private Bag 1921
Dunedin 9054
Country 55955 0
New Zealand
Phone 55955 0
64 3 4709347
Fax 55955 0
64 3 4709221
Email 55955 0
miranda.buhler@southerndhb.govt.nz
Contact person for scientific queries
Name 55956 0
Miranda Buhler
Address 55956 0
Physiotherapy Outpatient Department
Dunedin Hospital
Southern District Health Board
Private Bag 1921
Dunedin 9054
Country 55956 0
New Zealand
Phone 55956 0
64 3 4709347
Fax 55956 0
64 3 4709221
Email 55956 0
miranda.buhler@southerndhb.govt.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Not yet decided what data will be shared - decision may change


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.