Knee OsteoarthritisLUNANCT05057559
Observational Clinical Investigation of Arthrosamid in Knee Osteoarthritis
An observational study of Knee Osteoarthritis, run by Contura at 9 sites in 5 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthritis
- How many people
- 201 participants
- Where
- 9 sitesin 5 countries
- Study dates
- 21 Apr 2021to 1 Jan 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be recruited from participating rheumatology or orthopedic centers.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
9 sites in 5 countries.
9 sites in 5 countries
Germany2 sites
AmBeNet Hausarztpraxis
Leipzig
University Medical Center of Johannes Gutenberg-University Mainz (UMC-Mainz)
Mainz, 55131
United Kingdom2 sites
London North West University Healthcare
London
Royal Cornwall Hospital
Truro
About this study
Official title: Prospective, Observational, Open-label, Clinical Investigation of Intra-articular Arthrosamid® Injection in Subjects With Knee Osteoarthritis
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.
Read the 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.
- Conditions
- Knee Osteoarthritis
- Medical subject headings
- Osteoarthritis, Knee
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse events
The total number of treatment emergent adverse events
Measured: 5 years
Secondary outcomes (4)
WOMAC pain subscale
change from baseline in WOMAC (WOMAC Osteoarthritis Index) pain subscale
Measured: 6, 12, 24, 36, 48 and 60 months
WOMAC stiffness subscale
change from baseline in WOMAC (WOMAC Osteoarthritis Index) stiffness subscale
Measured: 6, 12, 24, 36, 48 and 60 months
WOMAC physical function subscale
change from baseline in WOMAC (WOMAC Osteoarthritis Index) physical function subscale
Measured: 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"
Measured: 6, 12, 24, 36, 48 and 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2021
- Study start21 Apr 2021
- Primary completion1 Jan 2029 (estimated)
- Study completion1 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Contura
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dorthe Tvinnemose, DVM., Study chair, Contura
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05057559
- Sponsor's protocol ID
- CON-OA-002
- Acronym
- LUNA
- Status last verified
- Sep 2026
- First submitted
- 16 Sep 2021
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Observational, Open-label, Clinical Investigation of Intra-articular Arthrosamid® Injection in Subjects With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT05057559
- Acronym / sponsor ID
- LUNA / CON-OA-002
- Conditions
- Knee Osteoarthritis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 201 participants (actual)
- Lead sponsor
- ConturaIndustry (pharma, biotech, devices)
- Study start
- 21 Apr 2021 (actual)
- Primary completion
- 1 Jan 2029 (estimated)
- Study completion
- 1 Jan 2029 (estimated)
- First posted
- 27 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited from participating rheumatology or orthopedic centers.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of adverse events
Time frame: 5 years
The total number of treatment emergent adverse events
4 secondary outcomes
WOMAC pain subscale
Time frame: 6, 12, 24, 36, 48 and 60 months
WOMAC stiffness subscale
Time frame: 6, 12, 24, 36, 48 and 60 months
WOMAC physical function subscale
Time frame: 6, 12, 24, 36, 48 and 60 months
Patient's global assessment of impact of osteoarthritis
Time frame: 6, 12, 24, 36, 48 and 60 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dorthe Tvinnemose, DVM. study chair
Contura
9 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Osteoarthritis, run by Contura at 9 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Denmark, France, Germany, United Kingdom, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of adverse events (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.