Arthrosamid Injection for OA Knee

Mechanistic and Clinical Study of Intra-articular Arthrosamid for Knee Osteoarthritis

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Device: Arthrosamid

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Shropshire
    • Oswestry, Shropshire, United Kingdom, SY10 7AG
      • The Robert Jones and Agnes Hunt Orthopaedic Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Arthrosamid Inj; Single arm study - no comparator	Device: Arthrosamid; Intra-articular hydrogel injection comprising of water and cross-linked polyacrylamide.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score between baseline (pre-injection) and 6 months and 12 months post-injection.	The WOMAC score includes 3 subscales related to pain, stiffness and function; the higher is the WOMAC score, the worse is the joint function.	6 months and 12 months post injection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood and synovial fluid biochemical and biomarker levels pre- and post-injection	Biochemical and biomarkers to assess clinical effectiveness	Pre-injection and at 3 months
Knee Injury and Osteoarthritis Outcome Score (KOOS)	A knee-specific tool, developed to assess the patients' opinion about their knee and associated problems.	Pre-injection, 3, 6 and 12 months post-injection
Analgesia requirement 1 week prior to Patient Reported Outcome Measurement (PROM) collection	Type and dosage of concomitant medication, specifically analgesia taken in period prior to PROM collection	Pre-injection, 3, 6 and 12 months post-injection

Collaborators and Investigators

• Sponsor: Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2022
• Primary Completion (Actual): December 19, 2023
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: October 1, 2021
• First Submitted That Met QC Criteria: October 18, 2021
• First Posted (Actual): October 20, 2021

Study Record Updates

• Last Update Posted (Estimated): December 27, 2023
• Last Update Submitted That Met QC Criteria: December 20, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: RL1 840

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No