Observational Clinical Investigation of Arthrosamid in Knee Osteoarthritis

Knee Osteoarthritis Clinical Trial

— LUNA  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05057559
• Other study ID #: CON-OA-002
• Status: Active, not recruiting
• Start date: April 21, 2021
• Est. completion date: July 1, 2028

Study information

• Verified date: January 2024
• Source: Contura
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 201
• Est. completion date: July 1, 2028
• Est. primary completion date: July 1, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Contura

Countries where clinical trial is conducted

Denmark,  France,  Germany,  Italy,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of adverse events	The total number of treatment emergent adverse events	5 years
Secondary	WOMAC pain subscale	change from baseline in WOMAC (WOMAC Osteoarthritis Index) pain subscale	6, 12, 24, 36, 48 and 60 months
Secondary	WOMAC stiffness subscale	change from baseline in WOMAC (WOMAC Osteoarthritis Index) stiffness subscale	6, 12, 24, 36, 48 and 60 months
Secondary	WOMAC physical function subscale	change from baseline in WOMAC (WOMAC Osteoarthritis Index) physical function subscale	6, 12, 24, 36, 48 and 60 months
Secondary	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