Daily Activity and Clinical Outcome Measurement of Arthrosamid® Administration in Symptomatic Knee Osteoarthritis. (ACTA)

March 6, 2026 updated by: Philippe Van Overschelde, Medisch Centrum Latem

Evaluation of Daily Activity and Clinical Outcomes After a Single, Intra-articular, Injection of Arthrosamid® in Patients With Symptomatic Knee Osteoarthritis: a Monocentric Trial With a 12-month Follow-up Period

This study is a prospective, monocentric, interventional post-market study evaluating the effects of a single intra-articular injection of Arthrosamid in patients with symptomatic knee osteoarthritis. Arthrosamid is a polyacrylamide hydrogel consisting of 97.5% sterile water and 2.5% cross-linked polyacrylamide that integrates into the synovial tissue and is used for the symptomatic treatment of knee osteoarthritis.

The study will include 30 eligible patients receiving a single Arthrosamid injection and will be followed for up to 12 months. The primary objective is to evaluate the performance of Arthrosamid in terms of daily activities and clinical outcomes in patients with symptomatic knee osteoarthritis. The primary endpoint assesses the percentage change from baseline in daily activity levels at 6 months after injection, measured using an activity tracker combined with a digital rehabilitation tool. Additional assessments include patient-reported outcome measures and clinical follow-up visits conducted as part of standard care.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
29

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Oost-Vlaanderen
      • Sint-Martens-Latem, Oost-Vlaanderen, Belgium, 9830
        • Medisch Centrum Latem

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Subjects > 18 years of age at the time of injection

  • Advanced osteoarthritis, involving one or multiple of the following phenotypes: tricompartmental osteoarthritis, isolated or severe patella-femoral osteoarthritis, and/or a Kellgren and Lawrence grade II or III classification:

    • Patellofemoral osteoarthritis referring to symptoms, including pain, that are principally of patellofemoral origin (Patellar syndrome).
    • Radiological Kellgren and Lawrence grade II to III from a standing knee radiograph taken less than 6 months previously.
  • Subjects with a normal BMI ≥ 18.5 kg/m² and < 30 kg/m²
  • Symptomatic osteoarthritis diagnosed via radiographic assessment and according to the clinical and radiological criteria of the American College of Rheumatology
  • Fully ambulatory patient for functional evaluation.
  • Able to understand and follow the instructions of the study.
  • Having signed a written informed consent

Exclusion Criteria:

  • Meeting one of the following contraindications as stated in the instructions for use (IFU) of Arthrosamid®:

    • 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 the manufacturer's information for the specific product, before injection with Arthrosamid®
  • Other medical conditions contributing to the rehabilitation process of the injection according to the surgeon
  • Important medical conditions such as, Parkinson's Disease, dementia, multiple sclerosis and cerebral vascular accident, which can disturb the patient's rehabilitation after injection according to the surgeon
  • Patient is participating in another clinical trial or has participated in a clinical trial in the last three months
  • Patients who did not met all the inclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Arthrosamid Injection
Patients with symptomatic knee osteoarthritis receiving a single intra-articular injection of Arthrosamid and followed for clinical outcomes and activity levels for up to 12 months.
Device: Arthrosamid
Single intra-articular injection of Arthrosamid, a polyacrylamide hydrogel consisting of 97.5% sterile water and 2.5% cross-linked polyacrylamide, administered for the symptomatic treatment of knee osteoarthritis.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage Change From Baseline in Daily Activity Levels
Time Frame: 6 months follow-up
Percentage change from baseline in daily activity levels at 6 months after a single intra-articular Arthrosamid injection, measured using an activity tracker coupled with a digital rehabilitation tool.
6 months follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage Change From Baseline in Daily Activity Levels
Time Frame: 12 months follow-up
Percentage change from baseline in daily activity levels at 12 months after a single intra-articular Arthrosamid injection, measured using an activity tracker coupled with a digital rehabilitation tool.
12 months follow-up
Change From Baseline in Patient-Reported Outcome Measures
Time Frame: 7 to 14 days before injection, Day 0 (baseline), 2 weeks, 6 weeks, 3 months, 6 months, and 12 months follow-up
Absolute and percentage change from baseline in patient-reported outcome measures (PROMs), including KOOS (total and subscales), Oxford Knee Score, Forgotten Joint Score (FJS), EQ-5D, UCLA Activity Score, and the moveUP index score, in patients with symptomatic knee osteoarthritis treated with Arthrosamid.
7 to 14 days before injection, Day 0 (baseline), 2 weeks, 6 weeks, 3 months, 6 months, and 12 months follow-up

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Rescue Medication Consumption
Time Frame: 2 weeks, 6 weeks, 3 months, 6 months, and 12 months follow-up
Consumption of concomitant or rescue medication in patients with symptomatic knee osteoarthritis following a single intra-articular Arthrosamid injection, assessed at multiple follow-up time points.
2 weeks, 6 weeks, 3 months, 6 months, and 12 months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medisch Centrum Latem

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Contura

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 25, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 6, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 12, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BUN3002024000098
  • 6568 (Other Identifier: Ethics Committee UZA/UAntwerpen)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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