Observational Clinical Investigation of Arthrosamid in Knee Osteoarthritis

Study Overview
=================
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.

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

Conditions
-----------------
Knee Osteoarthritis

Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

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 |