Observational Clinical Investigation of Arthrosamid in Knee Osteoarthritis

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05057559

Acronym

LUNA

Enrollment

201

Registered

2021-09-27

Start date

2021-04-21

Completion date

2029-01-01

Last updated

2026-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Osteoarthritis

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Number of adverse events	5 years	The total number of treatment emergent adverse events

Secondary

Measure	Time frame	Description
WOMAC pain subscale	6, 12, 24, 36, 48 and 60 months	change from baseline in WOMAC (WOMAC Osteoarthritis Index) pain subscale
WOMAC stiffness subscale	6, 12, 24, 36, 48 and 60 months	change from baseline in WOMAC (WOMAC Osteoarthritis Index) stiffness 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"

Countries

Denmark, France, Germany, Italy, United Kingdom

Contacts

STUDY_CHAIRDorthe Tvinnemose, DVM.

Contura

Outcome results