Arthrosamid Injection for OA Knee

NCT ID: NCT05086068

Last Updated: 2023-12-27

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-16
• Study Completion Date: 2024-12-31

Brief Summary

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.

Detailed 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.

Conditions

Osteoarthritis, Knee

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arthrosamid Inj

Single arm study - no comparator

Group Type: OTHER

Arthrosamid

Intervention Type: DEVICE

Intra-articular hydrogel injection comprising of water and cross-linked polyacrylamide.

Interventions

Arthrosamid

Intra-articular hydrogel injection comprising of water and cross-linked polyacrylamide.

Intervention Type: DEVICE

Eligibility Criteria

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

• Previous trauma with significant alteration in bone architecture
• Symptoms of spinal disease
• Prior injection in the last 12 months
• Joint re-placement operation on the other knee
• Cognitive disorders
• Inflammatory arthritis (i.e., rheumatoid arthritis, spondylarthritis and gout)
• Fibromyalgia
• Auto-immune disease (i.e., connective tissue disorders)
• Previous history of septic arthritis.
• Unwilling or unable to give informed consent

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Robert Jones and Agnes Hunt Orthopaedic Hospital

Oswestry, Shropshire, United Kingdom

Countries

United Kingdom

Other Identifiers

RL1 840

Identifier Type: -

Identifier Source: org_study_id