Clinical trial NCT05057559: Observational Clinical Investigation of Arthrosamid in Knee Osteoarthritis
Official title: Prospective, Observational, Open-label, Clinical Investigation of Intra-articular Arthrosamid® Injection in Subjects With Knee Osteoarthritis
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Knee Osteoarthritis
Lead sponsor: Contura
Sponsor class: INDUSTRY
First posted: 2021-09-27
Enrollment: 201
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients will be recruited from participating rheumatology or orthopedic centers.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of adverse events
timeFrame: 5 years
Secondary outcomes:
measure: WOMAC pain subscale
timeFrame: 6, 12, 24, 36, 48 and 60 months
measure: WOMAC stiffness subscale
timeFrame: 6, 12, 24, 36, 48 and 60 months
measure: WOMAC physical function subscale
timeFrame: 6, 12, 24, 36, 48 and 60 months
measure: Patient's global assessment of impact of osteoarthritis
timeFrame: 6, 12, 24, 36, 48 and 60 months
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: The Parker Institute
city: Odense
country: Denmark
facility: Reumatolog i Odense
city: Marseille
country: France
facility: AP-HM hopitaux
city: Poissy
country: France
facility: Clinique Saint Louis
city: Leipzig
country: Germany
facility: AmBeNet Hausarztpraxis
city: Mainz
country: Germany
facility: University Medical Center of Johannes Gutenberg-University Mainz (UMC-Mainz)
city: Rom
country: Italy
facility: Ospedale San Pietro Fatebenefratelli
city: London
country: United Kingdom
facility: London North West University Healthcare
city: Truro
country: United Kingdom
facility: Royal Cornwall Hospital
Study officials:
affiliation: Contura
name: Dorthe Tvinnemose, DVM.
role: STUDY_CHAIR
References: