None listed
Conditions
Brief summary
Title Autologous Protein Solution (APS) – the Biological symptom management of HIP osteoarthritis. The hypothesis of this study is that a single injection of APS (nSTRIDE, Zimmer Biomet USA) a product derived from the participant's own blood, is safe and leads to a reduction in hip pain and an improvement in hip function at 3 months which is sustained at 12 months. This will be tested in 10 participants aged over 40 years with painful hip osteoarthritis and mild to moderately severe structural change on x-rays.
Interventions
Preparation of the APS is according to the manufacturers instructions - 55 mls of blood is collected in a tube with 5 mls of anti-coagulant. This is centrifuged for 15 minutes at 3200 rpm. 6 mls of PRP is then transferred to the APS cannister and centrifuged again for 2 minutes at 2000 rpm. the resultant APS is a single 3 ml dose.
A single 3 ml injection of Autologous Protein Solution into the hip joint under ultrasound guidance according to standard hip protocols and an aseptic technique. This
Preparation of the APS is according to the manufacturers instructions - 55 mls of blood is collected in a tube with 5 mls of anti-coagulant. This is centrifuged for 15 minutes at 3200 rpm. 6 mls of PRP is then transferred to the APS cannister and centrifuged again for 2 minutes at 2000 rpm. the resultant APS is a single 3 ml dose. A single 3 ml injection of Autologous Protein Solution into the hip joint under ultrasound guidance according to standard hip protocols and an aseptic technique. This is done by an experienced Sport and Exercise Medicine Physician or radiologist. A second sample of APS is prepared at the same time and sent to the laboratory for growth factor analysis
Sponsors
.University of Melbourne
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
(i) aged>40 years; (ii) hip pain on most days in the last month; (iii) X-ray confirmation of the diagnosis of hip osteoarthritis with Kellgren and Lawrence (KL) grade 2-3 (iv) A minimum pain score of 4 on an 11-point numeric rating scale for the last week having ceased all pain medications 5 days prior
Exclusion criteria
(i) X-ray confirmation of the diagnosis with Kellgren and Lawrence (KL) grade 1 indicating questionable disease or grade 4 indicating severe disease; (ii) Hip dysplasia or past Perthes disease or slipped upper femoral epiphysis; (iii) Radiographic evidence of avascular necrosis (iv) Hyaluronic acid injection in past 6 months, corticosteroid injection in past 3 months or autologous blood product in the past 12 months; (v) Hip surgery on the affected side within the past 12 months; (vi) systemic or inflammatory joint disease; (vii) history of crystalline or neuropathic arthropathy; (viii) plan for joint surgery in next 12 months; (ix) other muscular, joint or neurological condition affecting lower limb function; (x) needle phobia; (xi) immunosuppression or acute infective processes; (xii) cancer or other tumour-like lesions; (xiii) bleeding disorder or receiving anti-coagulation therapy (at the discretion of the PI); (xiv) any other medical condition precluding participation in the study including contraindication to MRI such as pregnancy; (xv) Inability to understand written/spoken English.
Outcome results
None listed