None listed
Conditions
Brief summary
Knee osteoarthritis is a common condition that affects the cartilage lining of the knee joint and causes pain and stiffness. It is therefore important to find effective treatments that improve people’s symptoms and quality of life, and also slow down the loss of joint cartilage that happens in osteoarthritis. One such therapy that may be effective is platelet-rich plasma (PRP) injections. This treatment involves an injection of the person’s own PRP, which is made from blood taken from their arm and injected into their knee. Blood contains plasma, red blood cells, white blood cells and platelets that release chemicals which can stimulate the healing process. This may give rise to improvements in symptoms and slowing of the disease process. This study aims to find out whether a series of three PRP injections (one per week for three weeks) into the knee joint is effective in reducing pain and slowing loss of cartilage in the knee joint. To do this, we will compare outcomes over 12 months in a group of patients with knee osteoarthritis who receive three PRP injections and a group who receive three injections of inactive sterile salt injections (saline). We will recruit 288 people with mild to moderately severe knee osteoarthritis from the community. Measurements will be taken at baseline, 2 months and 12 months and will comprise questionnaires and magnetic resonance imaging. Participants will be randomly allocated to either the PRP or saline injection group and neither the participant, nor the injecting doctor or the assessor will know which injection the participant will receive.
Interventions
Platelet-rich plasma (PRP) injections into the knee joint.
PRP injections are made from withdrawing and centrifuging the participant’s own blood on the day of treatment. An injection of PRP will be administered to participant’s study knee by a qualified doctor under ultrasound guidance once per week for three weeks.
Approximately 20mL of blood from the participant’s arm will be drawn. A research nurse will prepare the injection, and both the participant and injecting doctor will not be told wh
Platelet-rich plasma (PRP) injections into the knee joint. PRP injections are made from withdrawing and centrifuging the participant’s own blood on the day of treatment. An injection of PRP will be administered to participant’s study knee by a qualified doctor under ultrasound guidance once per week for three weeks. Approximately 20mL of blood from the participant’s arm will be drawn. A research nurse will prepare the injection, and both the participant and injecting doctor will not be told which treatment group the participant is allocated to. The whole blood sample will be centrifuged in a separate room to allow extraction of the PRP. A portion of the PRP will be withdrawn and saved for analysis, and approximately 5mL withdrawn into a syringe. The syringe will then be covered with a patient label, such that the injecting doctor will not know or be able to tell whether the syringe has PRP or placebo (saline). The doctor will then inject local anaesthetic superficially (which is optional for the participant), and then perform the PRP injection in to the knee joint under ultrasound guidance. Participants will return to the site radiology clinic for their second injection of PRP approximately one week later, and again for a third and final injection approximately one week after that. The injection process will be the same as the first injection.
Sponsors
University of Melbourne
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
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1) aged greater than or equal to 50 years; 2) knee pain on most days in the last month; 3) tibiofemoral osteophytes on x-ray; and 4) A minimum pain score of 4 on an 11-point numeric rating scale for the last week.
Exclusion criteria
1) Kellgren and Lawrence (KL) grade 1 indicating questionable disease or grade 4 indicating severe disease; 2) predominant lateral tibiofemoral disease; 3) Hyaluronic acid injection in past 6 months, corticosteroid injection in past 3 months or autologous blood product in the past; 4) knee surgery on their most painful knee within past 12 months; 5) systemic or inflammatory joint disease; 6) history of crystalline or neuropathic arthropathy; 7) knee joint replacement or high tibial osteotomy on their most painful knee; 8) plan for joint surgery in next 12 months; 9) other muscular, joint or neurological condition affecting lower limb function; 10) needle phobia; 11) immunosuppression or acute infective processes; 12) cancer or other tumour-like lesions; 13) bleeding disorder or receiving anti-coagulation therapy; 14) presence of a warm tense joint effusion; 15) platelet count greater than or equal to 150,000/microlitre; 16) any other medical condition precluding participation in the study including contraindication to MRI such as pregnancy; 17) be unwilling to discontinue NSAID and other analgesic usage for knee pain, with the exception of paracetamol for rescue pain relief, from 2 weeks prior to baseline assessment until the 12 month follow up assessment; 18) Body mass index (BMI) >40kg/m2 because of problems fitting in to the MRI machine knee coil; and 19) Inability to understand written/spoken English.
Outcome results
None listed