Safety of Use and Efficacy of Pandora for Patients Suffering From Gonarthrosis (PANDORA2) (NCT05978180) | Clinical Trial Compass
CompletedNot Applicable
Safety of Use and Efficacy of Pandora for Patients Suffering From Gonarthrosis (PANDORA2)
France252 participantsStarted 2023-10-18
Plain-language summary
The knee osteoarthritis is a frequent degenerative condition that mainly affects subjects over 60, population often weakened by numerous comorbidities and concomitant treatments, justifying the development of new therapies.
The viscosupplementation is a symptomatic treatment for knee osteoarthritis ; the objective of this intra-articular injection of hyaluronic acid is to reduce knee pain and improve mobility. In practice, there are two protocols to administer viscosupplementation : in a single injection or in three injections performed weekly.
The present clinical investigation has the objective to evaluate the safety and efficacy of use of Pandora, a hyaluronic acid associated with tranexamic acid, in a single injection (HO-1) or in three injections performed weekly (HS-3), compared to a referred and commercialized medical device.
Who can participate
Age range35 Years – 85 Years
SexALL
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Inclusion Criteria :
* Patient aged between 35 and 85 years.
* Body mass index (BMI) \< 35 kg.m2.
* Medial or lateral femoro-tibial knee osteoarthritis, diagnosed according to the American College of Rheumatology criteria, radiological stage 2 and 3 according to the Kellgren-Lawrence criteria modified by Felson on an X-ray, of the knee in extension, less than 6 months old.
* Knee osteoarthritis responsible for walking pain in the target knee, assessed between 4 and 8 inclusive on an 11 points numerical scale (0 = none to 10 = extreme).
* Unilateral or bilateral knee osteoarthritis if the walking pain in the contralateral knee is \< 3 based on 11 points numerical scale (0-10).
* Ambulatory patient able to walk 50 meters without a cane, crutch or walker.
* Patient giving his informed consent.
* Patient agreeing to follow-up study visits.
* Patient affiliated to the health social security system or beneficiary of such plan.
* Patient requiring viscosupplementation according to the investigator.
Exclusion Criteria :
* Patient presenting knee osteoarthritis without impingement joint space narrowing of the femoro-tibial compartment (modified Kellgren stage 0-1) or with complete impingement joint space narrowing on the knee weight-bearing radiograph in extension (modified Kellgren stage 4).
* Patient with bilateral symptomatic gonarthrosis with walking pain of contralateral knee \> 3.
* Patient with stage 4 patello-femoral osteoarthritis associated with femoro-tibial osteoarthrit…
What they're measuring
1
To evaluate the efficacy of the two medical devices containing Pandora gel, HO-1 and HS-3, on walking pain in the target knee, compared to the SINOVIAL® ONE.