Observational Clinical Investigation of Arthrosamid in Knee Osteoarthritis

Active, not recruiting

• Conditions: Knee Osteoarthritis

• Registration Number: NCT05057559
• Lead Sponsor: Contura

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.

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 Timeline

• Study Start: 2021-04-21
• Study First Submitted: 2021-09-16
• Study First Submitted QC: 2021-09-16
• Study First Posted: 2021-09-27
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-04
• Last Update Posted: 2024-01-05
• Primary Completion: 2028-07-01
• Study Completion: 2028-07-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 201

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of adverse events	5 years	The total number of treatment emergent adverse events

Secondary Outcome Measures

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

Trial Locations

Locations (9)

Reumatolog i Odense; 🇩🇰 Odense, Denmark

Clinique Saint Louis; 🇫🇷 Poissy, France

AmBeNet Hausarztpraxis; 🇩🇪 Leipzig, Germany

London North West University Healthcare; 🇬🇧 London, United Kingdom

Royal Cornwall Hospital; 🇬🇧 Truro, United Kingdom

Ospedale San Pietro Fatebenefratelli; 🇮🇹 Rom, Italy

AP-HM hopitaux; 🇫🇷 Marseille, France

University Medical Center of Johannes Gutenberg-University Mainz (UMC-Mainz); 🇩🇪 Mainz, Germany

The Parker Institute; 🇩🇰 Copenhagen, Denmark