None listed
Conditions
Brief summary
Pain and disability from knee osteoarthritis is a significant source of morbidity in the population. Intra-articular steroid, hyaluronic acid and platelet-rich protein have all been investigated for treatment of osteoarthitis. The autologous protein solution was developed as a biologic therapy that concentrates specific anti-inflammatory cytokines (particularly interleukin-1 receptor antagonist and soluble tumour necrosis factor-receptor I and II) as well as growth factors. Pre-clinical studies demonstrated high concentrations of these anti-inflammatory mediators, and low concentration of pro-inflammatory cytokines in the autologous protein solution. They demonstrated inhibition of MMP production (protease involved in cartilage degradation) and reduced cartilage breakdown products in vitro. An animal study demonstrated reduced lameness in horses. Small human trials have demonstrated an acceptable safety profile and improved patient reported outcome scores. We plan to assess the effect of a single APS injection on knee pain and function compared to placebo at 1, 3, 6 and 12 months
Interventions
The intervention is an intra-articular injection of "autologous protein solution" produced from a patient's own blood via a provided centrifuge kit that involves separating and then concentrating the blood products.
60mls of blood is drawn from the patient. The resultant injection is approximately 3mls. This is injected in to the affected knee, immediately after it is drawn and processed (which takes about 20 minutes) using ultrasound guidance to confirm intra-articular placement, by one of th
The intervention is an intra-articular injection of "autologous protein solution" produced from a patient's own blood via a provided centrifuge kit that involves separating and then concentrating the blood products. 60mls of blood is drawn from the patient. The resultant injection is approximately 3mls. This is injected in to the affected knee, immediately after it is drawn and processed (which takes about 20 minutes) using ultrasound guidance to confirm intra-articular placement, by one of the study doctors. It is a single administration
Sponsors
Northland DHB
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
21 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Unilateral knee osteoarthritis Kellgren-Lawrence grade 2-3 Failed at least one non-operative management BMI <40
Exclusion criteria
Active infection Osteoarthritis in the contralateral knee Diagnosis other than osteoarthritis (e.g. inflammatory arthritis, gout, paget's disease, etc) in the affected knee Other cause for pain as judged by the investigator (e.g. hip, spine pathology, acute injury) Presence of surgical implants in the affected knee Arthroscopic surgery on the affected knee within 6 months Steroid injection in the affected knee within 3 months Oral steroids within 2 weeks, or other systemic immunosuppressants within 6 weeks Planned surgery on the affected knee Local anaesthetic allergy Current treatment for leakaemia or other malignancy
Outcome results
None listed