None listed
Conditions
Brief summary
Osteoarthritis (OA) is a progressive degenerative disease characterised by loss or damage of the cartilage surface of joints, resulting in pain and disability. Unitl recently, management of mild to moderate OA has been limited to symptomatic relief with analgesia or anti-inflammatory medications, viscosupplementation and exercise therapy, and in extreme cases joint replacement surgery. An emerging treatment for soft tissue healing and bone mineralisation is platelet rich plasma (PRP) injection. In addition to clotting functions, activated platelets have been found to contain growth factors, cytokines and protiens responsible for promotion of tissue regeneration and healing. Injection of PRP solution to joints during surgical procedures have demonstrated positive effects on healing, pain and function post-operatively. However, to our knowledge, there are limited ramdomised controlled studies evaluating the effect of a less invasive technique of intra-articular injection of PRP. Therefore, this double blinded study aims to assess the changes in pain, activity levels and lower extremity functional ability of patients with mild to moderate OA following intra-articular PRP injection compared to usual treatment of Hylan G-F 20 (SYNVISC).
Interventions
To make the platelet rich plasma (PRP), 20 ml of the patient’s blood will be collected and centrifuged at 100g for 5 minutes. The plasma and buffy coat will be drawn from the top, placed in a sterile tube and activated using low-level light irradiation. The activated PRP will then be injected into the patient's symptomatic knee under ultrasound guidance.
Patients will receive three injections each of 5ml platelet-rich plasma one week apart. Time-points for injections: 1) initial injection, 2) o
To make the platelet rich plasma (PRP), 20 ml of the patient’s blood will be collected and centrifuged at 100g for 5 minutes. The plasma and buffy coat will be drawn from the top, placed in a sterile tube and activated using low-level light irradiation. The activated PRP will then be injected into the patient's symptomatic knee under ultrasound guidance. Patients will receive three injections each of 5ml platelet-rich plasma one week apart. Time-points for injections: 1) initial injection, 2) one week following initial injection and 3) two weeks following initial injection. This results in a total treatment duration of two weeks.
Sponsors
Kade Paterson
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
A diagnosis of OA assessed via the International Cartilage Repair Society guidelines and a visual analogue pain score of greater than 50 out of 100
Exclusion criteria
No systemic or inflammatory joint disease, no history of crystalline or neuropathic arthropathy, no cancer or other tumour-like lesions, not pregnant or lactating, not drug abusing, no other intra articular lesion in the previous six months, no allergy to any test substance and not immunosuppressed
Outcome results
None listed