Hydrogel Assessment for Local Treatment of Osteoarthritis
ConditionOsteo Arthritis of the Knee
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age35-75
SponsorAllegro NV/SA
About this trial
The study aims to evaluate the safety and tolerability of one intra-articular injection of Hydrogel OA 2% for the symptomatic treatment of osteoarthritis of the knee.
Eligibility criteria
Qualifiers
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 "stand-ing knee" X-ray. In case of bilateral KOA on X-ray only one knee (index knee) presents symptomatic OA pain.
Age 35 ≤ 75 years.
BMI 20 ≤ 35.
Disqualifiers
Bilateral tibiofemoral KOA where the non-index knee presents a worse radiological grade of KOA than the index knee.
Significant clinically assessed varus or valgus deformation of the selected knee side of more than 10 degrees.
Extension deficit of the index knee higher than 5 degrees.
Bilateral symptomatic tibiofemoral KOA or combined ipsilateral symptomatic tibiofemoral knee and hip OA.
Trial design
Treatments tested in this trial
- Injection of Hydrogel OA 2%
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov