Knee OsteoArthritis Long-term Assessment

NCT06839222 | Withdrawn

• 1 other identifier: DHF-001-DVaP-001-03
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 5

Brief Summary

The goal of this clinical study is to learn if Hydrogel OA 2% injection is safe and whether it works to improve symptoms of diagnosed knee osteoarthritis in adults when compared to Hyaluronic Acid (Durolane), a treatment that is currently often used for treatment of knee osteoarthritis. The main question it aims to answer is: \- How many study participants will experience side effects related to Hydrogel OA 2% during the study when compared to Hyaluronic Acid (Durolane)? All study participants will receive either one Hydrogel OA 2% or Hyaluronic Acid (Durolane) injection in their knee during the clinical study. Study participants will not know which treatment they have received. Study participants will also receive a call from the researchers and visit the clinic three times to report whether they have experienced any side effects, and complete a questionnaire that will ask questions on whether their symptoms have improved since they received an injection.

Conditions

Knee Osteoarthritis (Knee OA)

Keywords

Hydrogel OA 2%; Knee Osteoarthritis; Knee Injury and Osteoarthritis Outcome Score (KOOS); Safety; Hyaluronic acid

Outcome Measures

Primary Outcomes (1)

• Safety of Hydrogel OA 2% in subjects with symptomatic KOA

  The primary aim of this study is to test the safety of Hydrogel OA 2% in patients with symptomatic KOA. Specifically, the aim is to demonstrate that the proportion of patients experiencing Hydrogel OA 2%-related AEs is equal to the the proportion of patients experiencing Durolane-related AEs .

  From the treatment to the end of the follow up at 26 weeks

Secondary Outcomes (1)

• The improvement in the Knee Injury and Osteoarthritis Outcome Score (KOOS) 'Pain' score at 26 weeks after treatment

  From the treatment to the end of the follow up at 26 weeks

Other Outcomes (1)

• An improvement in Knee Injury and Osteoarthritis Outcome Score (KOOS) scores at 26 weeks after treatment, compared to baseline.

  From the treatment to the end of the follow up at 26 weeks

Study Arms (2)

Hydrogel OA 2%

EXPERIMENTAL

treatment arm

Device: Hydrogel OA 2%

Hyaluronic Acid (Durolane)

ACTIVE COMPARATOR

control arm

Device: Hyaluronic Acid (Durolane)

Interventions

Hydrogel OA 2% DEVICE

Hydrogel OA 2% is a sterile, nonpyrogenic viscoelastic hydrogel suspension, designed using highly purified biopolymers in a phosphate-buffered saline solution. The main component is a cross-linked protein (ultra-pure bovine gelatin). The other main component is a polysaccharide cellulose nanocrystal (CNC) that acts as the crosslinker. Hydrogel OA 2% is supplied in pre-filled 2.25ml Luer lock syringe. Each package contains one syringe containing 2.0 mL Hydrogel OA 2%. Hydrogel OA 2% is designed to provide symptomatic relief by restoring joint lubrication and cushioning, potentially leading to reduced pain and improved joint function. The device is suitable for use in early and moderate OA (Kellgren and Lawrence, K\&L, II-III).

Hydrogel OA 2%

Hyaluronic Acid (Durolane) DEVICE

DUROLANE contains 20 mg/mL of stabilized non-animal hyaluronic acid in buffered physiological sodium chloride solution pH 7. DUROLANE is a sterile, transparent viscoelastic gel supplied in a 3 mL glass syringe.

Hyaluronic Acid (Durolane)

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults accepting to participate in the study and having signed the written informed consent form before any protocol-specific procedures and able to understand and follow the instructions as described in the protocol.
• Unilateral symptomatic tibiofemoral KOA confirmed by a "standing knee" X-ray. In case of bilateral KOA on X-ray only one knee (indexed knee) presents symptomatic OA pain.
• Age 35 ≤ 75 years.
• BMI 20 ≤ 35.
• Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain score 25-85.
• Radiological Kellgren and Lawrence (K\&L) grade II and III from a standing knee radiograph with minimum joint space of 1 mm in the study knee.
• Fully ambulatory for functional assessments.
• Willingness to refrain from taking any pain medication for 48 hours prior to each study visit.
• Female subjects must be on effective contraception (pill, patch, ring, diaphragm, implant or intrauterine device), if not surgically sterile (tubal ligation or hysterectomy) or postmenopausal for at least one year. Females must show a negative pregnancy test at the treatment visit.

You may not qualify if:

• Bilateral tibiofemoral KOA where the non-symptomatic knee presents worse radiological grade of KOA.
• Radiological K\&L grade 0, I, or IV from a standing knee radiograph assessed during the screening visit, using the most recent x-ray taken either immediately or within the past 3 months. Significant clinically assessed varus or valgus deformation of the selected knee side of more than 10 degrees.
• Extension deficit of the index knee of higher than 5 degrees.
• Bilateral symptomatic tibiofemoral KOA or a combined unilateral symptomatic tibiofemoral knee and hip OA.
• Clinical signs of significant effusion with noticeable swelling and/or inflammation related severe pain during the treatment visit.
• Evidence of active lymphatic or venous stasis or serious blood disorders (e.g., anemia), bleeding disorders (e.g., hemophilia), blood clots, or blood cancers (e.g., leukemia, lymphoma, and myeloma).
• Active bacterial infection, resulting in hospitalization and/or requiring intravenous antibiotic treatment.
• Synovial infection, skin infections or any skin diseases in the area of the injection site.
• History of autoimmune diseases that cause chronic joint pain and inflammation in the knee joint, including rheumatoid arthritis, psoriasis arthritis, juvenile idiopathic arthritis, systemic lupus erythematosus, gout, pseudogout, systemic sclerosis, Sjögren's disease, adult-onset still's disease.
• Known or suspected generalized chronic pain disorder.
• Severe alteration of mobility preventing any functional assessment.
• Allergy or hypersensitivity to any of the product components.
• Conditions (orthopedic, rheumatologic, musculoskeletal or inflammatory) causing symptomatic and/or radiating pain in the lower extremities that might interfere with the symptomatic OA knee pain, including hip OA assessed by physical examination by the physician.
• Symptomatic patellofemoral knee OA.
• Oral corticotherapy ≥4 mg/day (in prednisone equivalent) in the last 3 months before injection.

Sponsors & Collaborators

• QbD Clinical: collaborator
• Allegro NV/SA: lead

Study Sites (5)

More Institute

Antwerp, Belgium

Location

AZ Sint Jan Brugge

Bruges, Belgium

Location

UZ Antwerpen

Edegem, Belgium

Location

CHU Liège

Liège, Belgium

Location

AZ DELTA

Roeselare, Belgium

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Knee Injuries

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Leg Injuries; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A randomized controlled, single-blind, multi-center, prospective first-inhuman clinical investigation.

Study Record Dates

• First Submitted: February 17, 2025
• First Posted: February 21, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: April 13, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

BE (5)