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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Injection of Hydrogel OA 2%
DeviceSingle injection
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: InterventionalExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Occurrence of Device- or Procedure-Related Serious Adverse Events
Occurrence of any device or procedure related (serious) adverse event up to 13 weeks after injection of the investigational device.
Time frame
13 weeksSecondary outcomes
1
Occurrence of Device- or Procedure-Related Serious Adverse Events
Occurrence of any device or procedure related (serious) adverse event up to 12 months after injection of the investigational device.
Time frame
12 monthsSponsors and contacts
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Source ClinicalTrials.gov