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Search / Trial NCT05086068

Arthrosamid Injection for OA Knee

Launched by ROBERT JONES AND AGNES HUNT ORTHOPAEDIC AND DISTRICT NHS TRUST · Oct 18, 2021

Trial Information

Current as of April 26, 2025

Active, not recruiting

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called Arthrosamid, which is an injection designed for people with knee osteoarthritis (OA). Osteoarthritis is a common condition that causes joint pain and stiffness, and current treatments like steroid injections usually only provide short-term relief and can harm the cartilage in the knee over time. Arthrosamid has been shown to be safe and effective, with benefits lasting more than two years for many patients. The trial aims to learn more about how Arthrosamid works and its effects on joint inflammation and pain.

To participate in the trial, individuals must be at least 18 years old and have a diagnosis of primary osteoarthritis, experiencing significant knee pain most days. They should have a specific level of joint damage and be willing to provide a small sample of joint fluid three months after receiving the injection. However, people with certain conditions, such as previous joint injuries, inflammatory arthritis, or cognitive disorders, may not be eligible. Participants can expect to receive the Arthrosamid injection and will be monitored for its effects over time. This study could help improve treatment options for knee osteoarthritis in the future.

Gender

ALL

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

About Robert Jones And Agnes Hunt Orthopaedic And District Nhs Trust

The Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust is a leading healthcare provider in orthopaedic care, dedicated to delivering high-quality clinical services and advancing medical research. Located in Oswestry, England, the Trust specializes in the diagnosis, treatment, and rehabilitation of musculoskeletal conditions, with a strong emphasis on innovation and evidence-based practice. As a clinical trial sponsor, the Trust collaborates with healthcare professionals and researchers to facilitate cutting-edge studies aimed at improving patient outcomes and enhancing the understanding of orthopaedic disorders. Its commitment to patient safety, ethical standards, and scientific integrity makes it a trusted partner in the advancement of orthopaedic medicine.

Locations

Oswestry, Shropshire, United Kingdom

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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