Arthrosamid Injection for OA Knee

Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust

Status

Active, not recruiting

Conditions

Osteoarthritis, Knee

Treatments

Device: Arthrosamid

Study type

Interventional

Funder types

Other

Identifiers

NCT05086068

RL1 840

Details and patient eligibility

About

Prior to surgical intervention, the conservative treatment of knee osteoarthritis involves analgesia and intra-articular injections and currently only steroid injections are available as part of NHS treatment. They have short-term benefit only (<6months) and potentially have detrimental effects on residual cartilage. Arthrosamid is a hydrogel consisting of 97.5% sterile water and 2.5% cross-linked polyacrylamide. It's been shown to be safe and effective, with benefits lasting beyond 2 years in the majority. However, currently it is unclear via what biological pathways it reduces joint inflammation and pain.

This study will investigate the effects of Arthrosamid clinically and biologically.

Full description

Prior to surgical intervention, the conservative treatment of knee osteoarthritis involves analgesia and intra-articular injections. Currently only steroid injections are available as part of NHS treatment. It is recognised they have short-term benefit only (<6months) and potentially have detrimental effects on residual cartilage. Arthrosamid is a hydrogel consisting of 97.5% sterile water and 2.5% cross-linked polyacrylamide. It's been shown to be safe and effective, with benefits lasting beyond 2 years in the majority. However, currently it is unclear via what biological pathways it reduces joint inflammation and pain.

Patients with osteoarthritis who are offered an intra-articular knee injection as part of standard care will be asked to enter the trial. On entering the trial baseline outcome measures will be recorded. The level of knee pain will be evaluated using Visual Analogue Scale (VAS). Patients will also be asked to complete the Knee injury and Osteoarthritis Outcome Score (KOOS) score and Western Ontario and McMaster Universities Arthritis Index (WOMAC). Patients will also declare the quantity of anti-inflammatory drugs and Oral analgesia that they have consumed.

At the time of treatment, a blood sample will be taken and under sterile conditions, synovial fluid will be aspirated from the knee prior to 6mls of Arthrosamid being injected. Patients will be reviewed by a researcher in a dedicated research clinic at 3,6 and 12 months post injection and the outcome measures repeated. At 3 months post injection synovial fluid and blood will again be collected from the patients. The blood and synovial fluid pre and post injection in patients who respond well to the injection will be compared to the samples from patients who fail to respond. The differences between the biochemical environments will allow us to identify likely pathways by which the injection reduces pain and inflammation.

Enrollment

60 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Primary OA according to the American College of Rheumatology criteria1.
Self-reported pain, aching, or stiffness of the index knee on most days of the past month, and a knee pain score of greater than 40 out of 100 on a visual analogue scale (VAS).
Radiological OA greater than Kellgren-Lawrence (K-L) grading scale 2
Patients aged over 18 years
Patient willing to undergo synovial sampling at 3 months post injection.

Exclusion criteria