Observational Clinical Investigation of Arthrosamid in Knee Osteoarthritis

NCT05057559 | Active Not Recruiting

• 1 other identifier: CON-OA-002
• Study Type: observational
• Target: 201
• Locations: 5 countries
• Sites: 9

Brief Summary

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.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Number of adverse events

  The total number of treatment emergent adverse events

  5 years

Secondary Outcomes (4)

• WOMAC pain subscale

  6, 12, 24, 36, 48 and 60 months

• WOMAC stiffness subscale

  6, 12, 24, 36, 48 and 60 months

• WOMAC physical function subscale

  6, 12, 24, 36, 48 and 60 months

• Patient's global assessment of impact of osteoarthritis

  6, 12, 24, 36, 48 and 60 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients will be recruited from participating rheumatology or orthopedic centers.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Contura: lead

Study Sites (9)

The Parker Institute

Copenhagen, Denmark

Location

Reumatolog i Odense

Odense, Denmark

Location

AP-HM hopitaux

Marseille, France

Location

Clinique Saint Louis

Poissy, France

Location

AmBeNet Hausarztpraxis

Leipzig, Germany

Location

University Medical Center of Johannes Gutenberg-University Mainz (UMC-Mainz)

Mainz, 55131, Germany

Location

Ospedale San Pietro Fatebenefratelli

Rome, Italy

Location

London North West University Healthcare

London, United Kingdom

Location

Royal Cornwall Hospital

Truro, United Kingdom

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Dorthe Tvinnemose, DVM.

  Contura

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2021
• First Posted: September 27, 2021
• Study Start: April 21, 2021
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: January 5, 2024

Record last verified: 2024-01

Locations

IT (1); FR (2); DE (2); DK (2); GB (2)