Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000055606
Ethics application status
Approved
Date submitted
8/01/2014
Date registered
20/01/2014
Date last updated
20/01/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of ultrasound-guided Platelet Rich Plasma injection to promote recovery in athletes with ankle syndesmosis injury. A pilot study
Scientific title
In ankle syndesmosis injury in Rugby Union players, how does a single ultrasound-guided Platelet Rich Plasma injection with conservative therapy compare to conservative therapy alone in terms of ankle pain, function and return to sport?
Secondary ID [1] 283913 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ankle Syndesmosis Sprain 290858 0
Condition category
Condition code
Musculoskeletal 291219 291219 0 0
Other muscular and skeletal disorders
Injuries and Accidents 291263 291263 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A single platelet-rich plasma (PRP) injection, administered intra-syndesmotically via ultrasound guidance within ten days of the initial ankle syndesmosis injury. This will be performed only once during the trial. Patients receiving the PRP procedure will have blood taken. Four to six blood collection tubes containing citrate will be obtained. Each will be labelled and confirmed with the patient with their correct identifying information.
- They will be centrifuged for 8 minutes at 2500 revolutions per minute. A 22gauge needle will be used to obtain 1-3mL of plasma, which is the platelet rich portion. The syringe of platelet rich plasma obtained will be labelled and confirmed with the patient with their correct identifying information.
- Ultrasound guidance will be used to localise the superficial peroneal nerve in identifying the safest pathway for injection of the anterior inferior tibiofibular ligament of the syndesmosis.
- Under sterile conditions, a 25 gauge needle will be used to inject 1-2mL local anaesthetic (1% lignocaine) into the skin and superficial tissues.
- An individualised dose of 2-3mL of the platelet rich plasma will then be injected into the point of the tear as visualised by ultrasound. The injection amount will depend on the size of the defect in the syndesmosis seen on ultrasound, with larger defects accommodating more platelet-rich plasma.
This all occurs in a single session lasting less than thirty minutes.
Intervention code [1] 288549 0
Treatment: Other
Comparator / control treatment
The results of this study will be compared to a conservatively treated group of 21 Rugby Union players with MRI confirmed ankle syndesmosis injuries, collected from 2011-2012 during a previous investigation (HREC no 13099). Conservative treatment consists of relative rest and graduated return to functional activity as guided by symptoms, monitored by the treating physiotherapist and Dr Katherine Rae, Sports and Exercise Medicine Physician. The results published demonstrated that conservatively treated ankle syndesmosis injuries took four times longer to recover from than lateral ankle sprains (PMID 24002346). Participants in the previous study consented for their data being used for determining the prognosis of recovery following a syndesmosis injury.
Control group
Historical

Outcomes
Primary outcome [1] 291213 0
Return to function - including return to normal activity, training and match-play. Return to match-play will be recorded as the first competitive match played by the athlete.
Timepoint [1] 291213 0
Subjects will be followed up for 12 months or until they return to match-play if less than 1 year.
Secondary outcome [1] 306246 0
VAS scores of pain- to assess pain numerically on a scale 0-100.
Timepoint [1] 306246 0
2 weeks post-injury (or 2 weeks after removal of Controlled Ankle Movement boot), and within 1 week of return to match-play. VAS scores will be recorded before and after the testing measures undertaken, in order to assess irritability.
Secondary outcome [2] 306407 0
Weight Bearing Lunge (toe to wall test) to assess loaded dorsiflexion.
Timepoint [2] 306407 0
2 weeks post-injury (or 2 weeks after removal of Controlled Ankle Movement boot), and within 1 week of return to match-play.
Secondary outcome [3] 306423 0
Vertical Jump- testing how high the athlete can jump using a standardised jumping mat.
Timepoint [3] 306423 0
2 weeks post-injury (or 2 weeks after removal of Controlled Ankle Movement boot), and within 1 week of return to match-play.
Secondary outcome [4] 306424 0
Star Excursion Balance- tests the athlete’s balance whilst they reach with their leg in different directions. Normalised for leg length.
Timepoint [4] 306424 0
2 weeks post-injury (or 2 weeks after removal of Controlled Ankle Movement boot), and within 1 week of return to match-play.
Secondary outcome [5] 306425 0
Fear Avoidance Beliefs Questionnaire (modified to assess subjects with ankle injury) to assess for behaviours associated with worry and fear because of injury.
Timepoint [5] 306425 0
2 weeks post-injury (or 2 weeks after removal of Controlled Ankle Movement boot), and within 1 week of return to match-play.
Secondary outcome [6] 306426 0
Illinois Agility Test from both the left and right side of the standardised obstacle set up.
Timepoint [6] 306426 0
Within 1 week of return to match-play.
Secondary outcome [7] 306427 0
Triple Hop- assesses the overall distance from three consecutive jumps on the same leg.
Timepoint [7] 306427 0
Within 1 week of return to match-play.

Eligibility
Key inclusion criteria
All players (male and female) aged 16 and over from football clubs competing in the Sydney Rugby Union Premiership Competition (all grades and levels) with acute ankle injury and signs of possible syndesmosis injury may participate in the study. They will require MRI confirmed ankle syndesmosis injury to be eligible for enrolment.
Minimum age
16 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- previous ankle surgery
- inter-current injury that causes more prolonged or severe disability, as judged by medical staff e.g.) knee injury requiring surgery and 6 months rehab
- non-syndesmosis related injury
- fracture of the foot or ankle
- concurrent grade 3 ATFL (anterior talofibular ligament) injury
- osteochondral defect
- tibiofibular separation by 4mm on MRI at the level of the talar dome
- pregnancy (all female participants of childbearing age will require a medical clearance including a urinary pregnancy test at screening)

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All consenting enrolled subjects will receive an un-blinded injection of PRP.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A t-test analysis will be appropriate to detect statistically significant differences between groups if normally distributed. Otherwise alternative analysis methods will be selected to compare groups.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2014
Actual
Date of last participant enrolment
Anticipated
27/09/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 288519 0
Government body
Name [1] 288519 0
Australian Institute of Sport
Tim Kelly, Manager
AIS Performance Research
Country [1] 288519 0
Australia
Primary sponsor type
Individual
Name
Dr David Samra
Address
The Sports Clinic, Crn Western Ave and Physics Rd, The University of Sydney
NSW 2006
Country
Australia
Secondary sponsor category [1] 287225 0
Individual
Name [1] 287225 0
Dr Katherine Rae
Address [1] 287225 0
The Sports Clinic, Crn Western Ave and Physics Rd, The University of Sydney
NSW 2006
Country [1] 287225 0
Australia
Secondary sponsor category [2] 287226 0
Individual
Name [2] 287226 0
Dr Amy Sman
Address [2] 287226 0
Kids Research Institute
The Children's Hospital at Westmead
Kerry Packer Building
Cnr Hawkesbury Rd and Hainsworth St
Westmead NSW 2145
Country [2] 287226 0
Australia
Secondary sponsor category [3] 287227 0
Individual
Name [3] 287227 0
Dr James Linklater
Address [3] 287227 0
Castlereagh Imaging
60 Pacific Highway,
ST LEONARDS
2065 NSW
Country [3] 287227 0
Australia
Secondary sponsor category [4] 287228 0
Individual
Name [4] 287228 0
Dr Claire Hiller
Address [4] 287228 0
C43S - S Block Cumberland Campus
The University of Sydney
Lidcombe
NSW 2141
Country [4] 287228 0
Australia
Secondary sponsor category [5] 287229 0
Individual
Name [5] 287229 0
Professor Kathryn Refshauge
Address [5] 287229 0
C43A - Jeffrey Miller Admin Building Cumberland Campus
The University of Sydney
Lidcombe
NSW 2141
Country [5] 287229 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290383 0
University of Sydney HREC
Ethics committee address [1] 290383 0
Margaret Telfer K07
University of Sydney
NSW 2006
Ethics committee country [1] 290383 0
Australia
Date submitted for ethics approval [1] 290383 0
Approval date [1] 290383 0
15/11/2013
Ethics approval number [1] 290383 0
2013/439

Summary
Brief summary
As a low risk, readily available treatment, PRP injection is becoming an increasingly popular therapeutic adjunct offered by musculoskeletal clinicians. However, there is a clear need to scientifically assess the merits of this treatment option for athletes with ankle syndesmosis injury in order to establish recommendations for evidence-based practice. Since there are no trials that have investigated PRP for ankle syndesmosis injury, this pilot study aims to assess the feasibility of progression to such a higher quality, larger scale trial.

If the treatment is shown to be beneficial, this would be of significant value to competitive and professional athletes who may otherwise require either a prolonged conservative treatment or a surgical treatment requiring at least six weeks of rest from competition.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 45410 0
Dr David Samra
Address 45410 0
The Sports Clinic, Crn Western Ave and Physics Rd, The University of Sydney
NSW 2006
Country 45410 0
Australia
Phone 45410 0
+612 477 275 715
Fax 45410 0
Email 45410 0
[email protected]
Contact person for public queries
Name 45411 0
Dr David Samra
Address 45411 0
The Sports Clinic, Crn Western Ave and Physics Rd, The University of Sydney
NSW 2006
Country 45411 0
Australia
Phone 45411 0
+612 477 275 715
Fax 45411 0
Email 45411 0
[email protected]
Contact person for scientific queries
Name 45412 0
Dr David Samra
Address 45412 0
The Sports Clinic, Crn Western Ave and Physics Rd, The University of Sydney
NSW 2006
Country 45412 0
Australia
Phone 45412 0
+612 477 275 715
Fax 45412 0
Email 45412 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

Current supporting documents:


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23306Ethical approval  [email protected]
23307Study protocol  [email protected]
23308Statistical analysis plan  [email protected]
23309Clinical study report  [email protected]
23310Informed consent form  [email protected]

Results publications and other study-related documents

Documents added manually
Current Study Results
No documents have been uploaded by study researchers.

Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
3803Basic resultsNo 365588-(Uploaded-26-04-2020-14-16-08)-Basic results summary.pdf
3959Plain language summaryNo The PRP cohort (intervention) and Retrospective co... [More Details]
4451Study results articleYes https://bmjopensem.bmj.com/content/1/1/e000033 ... [More Details]

Documents added automatically
No additional documents have been identified.