Observational Clinical Investigation of Arthrosamid in Knee Osteoarthritis (LUNA)

Prospective, Observational, Open-label, Clinical Investigation of Intra-articular Arthrosamid® Injection in Subjects With Knee Osteoarthritis

This is a prospective, long-term, observational, all-comers, open-label, multi-centre clinical investigation enrolling subjects with knee osteoarthritis who is eligible for treatment with Arthrosamid® according to the Instruction for Use.

Study Overview

• Status: Active, not recruiting
• Conditions: Knee Osteoarthritis

Detailed Description

This is a prospective, long-term, observational, all-comers, open-label, multi-centre clinical investigation enrolling subjects with knee OA who is eligible for treatment with Arthrosamid® according to the Instruction for Use (IFU).

All subjects will be followed over an observational period of five years with yearly follow-up check points. The first follow-up visit should be six months after the treatment. All follow up visits can be performed as telephone visits.

• Study Type: Observational
• Enrollment (Actual): 201

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark
    • The Parker Institute
  • Odense, Denmark
    • Reumatolog i Odense
• France
  • Marseille, France
    • AP-HM hopitaux
  • Poissy, France
    • Clinique Saint Louis
• Germany
  • Leipzig, Germany
    • AmBeNet Hausarztpraxis
  • Mainz, Germany, 55131
    • University Medical Center of Johannes Gutenberg-University Mainz (UMC-Mainz)
• Italy
  • Rom, Italy
    • Ospedale San Pietro Fatebenefratelli
• United Kingdom
  • London, United Kingdom
    • London North West University Healthcare
  • Truro, United Kingdom
    • Royal Cornwall Hospital

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Probability Sample

Study Population

Patients will be recruited from participating rheumatology or orthopedic centers.

Description

Inclusion Criteria:

• Stated willingness to comply with all study procedures and availability for the duration of the study
• Male or female, aged ≥ 18 years
• Clinical diagnosis of knee OA

Exclusion Criteria:

• If an active skin disease or infection is present at or near the injection site
• If the joint is infected or severely inflamed
• If a degradable intra-articular injectable such as hyaluronic acid is present, it must be expected to be absorbed according to manufacturer's information for the specific product, before injection with Arthrosamid®
• If the patient has previously received treatment with a different non-absorbable injectable/implant
• If the patient has received a knee alloplasty or has any foreign material in the knee
• If the patient has undergone knee arthroscopy within the last 6 months
• If the patient has haemophilia or is in uncontrolled anticoagulant treatment

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of adverse events	The total number of treatment emergent adverse events	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
WOMAC pain subscale	change from baseline in WOMAC (WOMAC Osteoarthritis Index) pain subscale	6, 12, 24, 36, 48 and 60 months
WOMAC stiffness subscale	change from baseline in WOMAC (WOMAC Osteoarthritis Index) stiffness subscale	6, 12, 24, 36, 48 and 60 months
WOMAC physical function subscale	change from baseline in WOMAC (WOMAC Osteoarthritis Index) physical function subscale	6, 12, 24, 36, 48 and 60 months
Patient's global assessment of impact of osteoarthritis	An eleven point, numeric rating scale (0-10) where 0 =" No impact" and 10 = "Worst imaginable impact"	6, 12, 24, 36, 48 and 60 months

Collaborators and Investigators

• Sponsor: Contura
• Investigators: Study Chair: Dorthe Tvinnemose, DVM., Contura

Study record dates

Study Major Dates

• Study Start (Actual): April 21, 2021
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028

Study Registration Dates

• First Submitted: September 16, 2021
• First Submitted That Met QC Criteria: September 16, 2021
• First Posted (Actual): September 27, 2021

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: January 4, 2024
• Last Verified: January 1, 2024

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: CON-OA-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No