Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000631707
Ethics application status
Not yet submitted
Date submitted
2/06/2013
Date registered
4/06/2013
Date last updated
4/06/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of protected early postoperative range of motion exercises versus cast immobilization in ankle fractures requiring surgery.
Scientific title
Protected early motion versus cast immobilization in postoperative Weber A,B,C ankle fractures. A prospective randomized control study to assess time to return to work.
Secondary ID [1] 282608 0
nil
Universal Trial Number (UTN)
U1111-1143-9654
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postoperative management of ankle fractures 289302 0
Condition category
Condition code
Surgery 289635 289635 0 0
Other surgery
Physical Medicine / Rehabilitation 289653 289653 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Early range of motion exercises will be prescribed by the surgical team, and be carried out under the guidance of physiotherapists at Christchurch Hospital. This will commence at the two week postoperative mark. The exercise regime will comprise of various ankle exercises lasting 20 minutes in total, and this will be repeated twice a day, for four weeks. The participants will get educated on the exercises by the physiotherapist or surgical team, and the exercises will be performed at home by the participants. Participants will be contacted by phone weekly to ensure no problems are encountered with the exercise, and also to increase compliance.
Intervention code [1] 287279 0
Rehabilitation
Intervention code [2] 287280 0
Treatment: Surgery
Comparator / control treatment
Conventional below knee cast immobilisation for six weeks.
Control group
Active

Outcomes
Primary outcome [1] 289719 0
Time to return to work is our primary outcome. This will be assessed at the outpatient follow up clinic at the 12 week postoperative mark. If the participant has not returned to work at this time, a phone interview will be performed at the 16 week mark to ascertain this information.
Timepoint [1] 289719 0
12 and 16 weeks post surgery
Secondary outcome [1] 303105 0
Ankle range of motion. This will be measured using the goniometer at the relevant follow-up clinics. Specifically, ankle dorsiflexion and plantarflexion will be measured.
Timepoint [1] 303105 0
Measured at 6, 12 and 16 weeks post surgery
Secondary outcome [2] 303106 0
Patient satisfaction Questionnaire using the Olerud & Molander Ankle Score The participants will fill out the score sheet at the 12 week follow-up clinic. Another copy will be given to the participants, which they will complete at the 16 week postoperative mark and the scores will be obtained through a phone interview.
Timepoint [2] 303106 0
12 and 16 weeks post surgery

Eligibility
Key inclusion criteria
1. Weber Classification A, B, and C ankle fractures, (including cases requiring diastasis screws), isolated medial malleolus fractures
2. Age 18-55
3. Able to safely mobilise non-weightbearing with crutches (physiotherapy assessment required whilst inpatient)
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Compound (open) injury
2. Smoker
3. Diabetic
4. History of previous ipsilateral ankle surgery

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)
Information of this study will be provided to patients whilst they are waiting for surgery in hospital. The first opportunity to discuss the study and its implications will be at this point. The participants will have at least 24 hours to contemplate the study on their own with or without support persons. Subsequently, the study coordinator will then have another discussion with the patients, and obtain their informed consent. The participants will have opportunities to discuss their participation in the study at subsequent postoperative follow up appointments. The participants will then be allocated to the intervention or control group by block randomization. Allocation concealment will be performed with the use of sealed opaque envelopes. Each envelope (stem) will have further sealed opaque envelopes (branches) within them (the number of envelopes will be determined by the block size). The branch envelopes will have either a 'control' or 'intervention', predetermined by random binary sequence generator. One stem envelope will be used for each strata (fracture type) until the desired number of block has been used up. A new stem envelope will be opened at this stage.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation will be done by stratified random assignment. There will be 4 strata, divided by the fracture type (Weber A, Weber B, Weber C, medial malleolus).
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
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Estimation of sample size: Standard power 80%, alpha value 0.05. The effect value was based on current available literature on early postoperative range of motion in ankle fractures; mean time to return to work was 96.6 days (SD 36.4).

Data will be described using means and standard deviations or medians and ranges, as well as application of parametric and non-parametric tests to test hypotheses respectively, depending on the distribution of obtained data. Chi-squared tests will be applied to comparisons of categorical data. Univariable and multi variable adjusted odds ratios with 95% confidence intervals will be used to explore variables associated with differences in outcome.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/06/2013
Actual
4/06/2013
Date of last participant enrolment
Anticipated
20/12/2013
Actual
4/06/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 5124 0
New Zealand
State/province [1] 5124 0
Christchurch

Funding & Sponsors
Funding source category [1] 287390 0
Self funded/Unfunded
Name [1] 287390 0
Unfunded study, performed by the coordinating investigator (Dr Alex Jae-Jin Lee)
Country [1] 287390 0
New Zealand
Primary sponsor type
Hospital
Name
Christchurch Hospital
Address
2 Riccarton Avenue
Riccarton
Christchurch 8011
New Zealand
Country
New Zealand
Secondary sponsor category [1] 286134 0
None
Name [1] 286134 0
Address [1] 286134 0
Country [1] 286134 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 289361 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 289361 0
Ministry of Health
No 1 The Terrace
PO Box 5013
Wellington
Ethics committee country [1] 289361 0
New Zealand
Date submitted for ethics approval [1] 289361 0
06/06/2013
Approval date [1] 289361 0
Ethics approval number [1] 289361 0

Summary
Brief summary
The study aims to compare the safety and effectiveness of early postoperative range of motion exercises in an ankle brace, versus conventional cast immobilization, in patients who undergo surgical fixation of their ankle fractures. The outcomes measured will be time to return to work, ankle range of motion, and patient satisfaction scores. We hypothesize that the early postoperative range of motion exercise group will have better outcomes compared to the conventional cast group.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 40478 0
Dr Alex Jae-Jin Lee
Address 40478 0
Christchurch Hospital, Canterbury District Health Board
2 Riccarton Avenue
Riccarton
Private Bag 4710
Christchurch 8011
Country 40478 0
New Zealand
Phone 40478 0
+64210745314
Fax 40478 0
Email 40478 0
[email protected]
Contact person for public queries
Name 40479 0
Dr Alex Jae-Jin Lee
Address 40479 0
Christchurch Hospital, Canterbury District Health Board
2 Riccarton Avenue
Riccarton
Private Bag 4710
Christchurch 8011
Country 40479 0
New Zealand
Phone 40479 0
+64210745314
Fax 40479 0
Email 40479 0
[email protected]
Contact person for scientific queries
Name 40480 0
Dr Alex Jae-Jin Lee
Address 40480 0
Christchurch Hospital, Canterbury District Health Board
2 Riccarton Avenue
Riccarton
Private Bag 4710
Christchurch 8011
Country 40480 0
New Zealand
Phone 40480 0
+64210745314
Fax 40480 0
Email 40480 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.