Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000366853
Ethics application status
Approved
Date submitted
29/03/2012
Date registered
29/03/2012
Date last updated
23/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Does the type of knee brace used after kneecap dislocation affect pain and function ?
Scientific title
The effect of full versus partial immobilisation on functional outcomes and redislocation rates in individuals with acute first time patella dislocations
Secondary ID [1] 280237 0
Nil
Universal Trial Number (UTN)
U1111-1129-5758
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patella dislocation 286193 0
Condition category
Condition code
Musculoskeletal 286390 286390 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 286395 286395 0 0
Physiotherapy
Injuries and Accidents 286396 286396 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants who present with a first time patella dislocation will be randomly assigned to one of two immobilisation braces (full or partial immobilisation) for 3 weeks. The partial immobilisation group will be the intervention. The full immobilisation brace maintains the knee in full extension, the partial immobilisation brace allows limited knee flexion and maintains pressure on the lateral side of the patella. Both groups will wear the allocated brace full-time for 3 weeks from the date of injury.
Intervention code [1] 284584 0
Treatment: Devices
Intervention code [2] 284585 0
Rehabilitation
Comparator / control treatment
The full immobilisation group is receiving the current standard treatment. The full immobilisation brace maintains the knee in full extension and will be worn full-time for 3 weeks from the date of injury.
Control group
Active

Outcomes
Primary outcome [1] 286847 0
Pain and functional outcomes measured with the Kujala scale.
Timepoint [1] 286847 0
1, 3, 6 and 12 months
Primary outcome [2] 286848 0
Re-dislocation rates measured by the number of fully documented re-dislocations that occur. Patella dislocations often spontaneously re-locate and for a dislocation to be recorded the event must be documented by a health professional or the participant must give a convincing account of a full dislocation.
Timepoint [2] 286848 0
1, 3, 6 and 12 months
Secondary outcome [1] 296805 0
Activity measured with the Tegner activity scale
Timepoint [1] 296805 0
1, 3, 6 and 12 months

Eligibility
Key inclusion criteria
Acute first time patella dislocation
Patients presenting to emergency department within 24 hours of injury
Evidence of dislocation: Reduced in emergency department OR dislocation clearly described by patient or qualified health professional
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Recurrent patellar dislocation
Lack of evidence of dislocation
Fracture or osteochondral lesion
Tibiofemoral ligament injury requiring repair
Previous knee surgery
Previous substantial knee injury
Pre- existing pathological condition of knee
Unable to follow treatment regimen
Non- English speaking participant or parent if participant under 18.

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)
Participants aged older than 12 years who suffer an acute patellar dislocation and present to the emergency department of Monash Medical Centre, Casey Hospital or Dandenong Hospital between June 2012 and June 2013 will be invited to participate in this study. Those who meet the inclusion criteria (and have no exclusion criteria) who sign informed consent (and their parents if aged less than 18 years) will be included in the study.
Once admitted to the emergency department, all eligible participants will be examined by a physiotherapist and have their affected knee immobilised in a Zimmer knee splint for 3 days. This rigid form of immobilisation is considered to be standard practice amongst Southern Health hospitals, and reflects the results of the few studies that have compared different forms of immobilisation for acute patellar dislocations. All patients will be provided with a gait aid and asked to weight bear as tolerated and receive education regarding on standard acute injury management procedures (rest, ice, compression, and elevation, with no heat, alcohol or massage). Information about this research project will be given to patients, and they will be asked to return for a review appointment 3 days after acute presentation. It is widely accepted that the acute inflammatory phase of wound healing has a duration of 72 hours (3 days) (Eaglstein, 1993), and therefore, all participants will receive this treatment regimen during the initial healing phase.
At the follow up appointment, a physiotherapist at Monash Medical Centre, Dandenong or Casey Hospital will review eligible patients. Those who consent to participate in this trial, will have their hypermobility assessed with the Beighton Scale and then they will be randomised accounting for their hypermobility status using sealed envelopes. Randomisation will be completed by someone external to the study and the intervention applied by the study participants.
Participants randomised to the control group will be instructed to continue wearing the Zimmer knee splint, while those in the intervention group will be fitted with a J- Lat brace (a patellar stabilising brace, Sportstek Australia) that provides partial immobilisation. All participants are will be instructed to wear their brace at all times, with weight bearing as tolerated. Participants in both groups will be immobilised for a period of 3 weeks from the original presentation at the hospital, and are not to participate in sport for 6 weeks. This duration of immobilisation reflects the standard practice at Southern Health hospitals, as well as the average immobilisation time as reported in current literature.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence will be generated using two sets of computer generated random allocations in permuted blocks: one set will be for subjects classified as 'no hypermobility', and the other for those classified as 'hypermobile'. These randomisation processes will be repeated to generate the same random allocation with permuted blocks model for each of the three participating sites.
Masking / blinding
Blinded (masking 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
Completed
Date of first participant enrolment
Anticipated
1/06/2012
Actual
1/06/2012
Date of last participant enrolment
Anticipated
Actual
1/07/2013
Date of last data collection
Anticipated
Actual
18/10/2013
Sample size
Target
60
Accrual to date
Final
6
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 285003 0
Self funded/Unfunded
Name [1] 285003 0
Country [1] 285003 0
Australia
Primary sponsor type
Hospital
Name
Southern Health
Address
246 Clayton Road
Clayton
Victoria 3168
Australia
Country
Australia
Secondary sponsor category [1] 283868 0
University
Name [1] 283868 0
Monash University
Address [1] 283868 0
PO Box 529
Frankston
Victoria 3199
Country [1] 283868 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287007 0
Southern Health Ethics committee
Ethics committee address [1] 287007 0
Ethics committee country [1] 287007 0
Australia
Date submitted for ethics approval [1] 287007 0
03/03/2012
Approval date [1] 287007 0
31/05/2012
Ethics approval number [1] 287007 0
12064B
Ethics committee name [2] 287008 0
Monash University Human Ethics committee
Ethics committee address [2] 287008 0
Ethics committee country [2] 287008 0
Australia
Date submitted for ethics approval [2] 287008 0
03/04/2012
Approval date [2] 287008 0
Ethics approval number [2] 287008 0

Summary
Brief summary
This study aims to compare standard full immobilisation protocols with partial immobilisation for 3 weeks on the functional and treatment outcomes and redislocation rates of individuals with first time patella dislocations.
It also aims to examine the effect of generalised joint hypermobility on outcomes after first-time patella dislocation.
Hypotheses
This study will test the hypothesis that those treated with the partial immobilisation brace will have better functional outcomes with no change in redislocation rates compared to full immobilisation. In addition, it is hypothesised that those treated with full immobilisation, will require more physiotherapy than those treated with a partial immobilisation stabilising brace, in order to regain the same level of function.
It is also hypothesised that participants with generalised joint hypermobility will have greater redislocation rates than those who are not hypermobile in both groups.
Trial website
Trial related presentations / publications
None
Public notes

Contacts
Principal investigator
Name 33994 0
Prof Jill Cook
Address 33994 0
La Trobe University
Kingsbury Drive
Melbourne 3086
Country 33994 0
Australia
Phone 33994 0
+61394792774
Fax 33994 0
Email 33994 0
J.Cook@latrobe.edu.au
Contact person for public queries
Name 17241 0
Prof Professor Jill Cook
Address 17241 0
Monash University, Peninsula campus
PO Box 529
Frankston
Victoria 3199
Australia
Country 17241 0
Australia
Phone 17241 0
+61 3 99044034
Fax 17241 0
+61 3 99044817
Email 17241 0
jill.cook@monash.edu
Contact person for scientific queries
Name 8169 0
Prof Professor Jill Cook
Address 8169 0
Monash University, Peninsula campus
PO Box 529
Frankston
Victoria 3199
Australia
Country 8169 0
Australia
Phone 8169 0
+61 3 99044034
Fax 8169 0
+61 3 99044817
Email 8169 0
jill.cook@monash.edu

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

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