None listed
Conditions
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.
Interventions
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 revoluti
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.
Sponsors
Dr David Samra
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
16 Years to 80 Years
Healthy volunteers
No
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.
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)
Outcome results
None listed