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

NCT07465601 | Active Not Recruiting

• 2 other identifiers: BUN30020240000986568
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Knee Osteoarthristis

Keywords

Knee Osteoarthritis; Arthrosamid; Polyacrylamide Hydrogel; Activity Monitoring; Intra-Articular Injection

Outcome Measures

Primary Outcomes (1)

• Percentage Change From Baseline in Daily Activity Levels

  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 Outcomes (2)

• Percentage Change From Baseline in Daily Activity Levels

  12 months follow-up

• Change From Baseline in Patient-Reported Outcome Measures

  7 to 14 days before injection, Day 0 (baseline), 2 weeks, 6 weeks, 3 months, 6 months, and 12 months follow-up

Other Outcomes (1)

• Rescue Medication Consumption

  2 weeks, 6 weeks, 3 months, 6 months, and 12 months follow-up

Study Arms (1)

Arthrosamid Injection

EXPERIMENTAL

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

Interventions

Arthrosamid DEVICE

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.

Arthrosamid Injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medisch Centrum Latem: lead
• Contura: collaborator

Study Sites (1)

Medisch Centrum Latem

Sint-Martens-Latem, Oost-Vlaanderen, 9830, Belgium

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Philippe Van Overschelde, MD, Orthopaedic Surgeon

Study Record Dates

• First Submitted: March 6, 2026
• First Posted: March 12, 2026
• Study Start: July 25, 2024
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2027
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)