Status:
COMPLETED
Post-market Study on TrHCROSS® in Knee Osteoarthritis After a Single Injection
Lead Sponsor:
i+Med S.Coop.
Collaborating Sponsors:
Hospital Universitario Araba
Bioaraba
Conditions:
Knee Osteoarthritis
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Double-blind study assessing the safety and efficacy of TrHCROSS® in knee osteoarthritis, compared to Hyalone®, using scales such as WOMAC, VAS, and KOOS. The population includes 60 symptomatic patien...
Eligibility Criteria
Inclusion
- Men or women between 18 and 80 years of age.
- Body mass index \<40 kg/m².
- Diagnosis of knee osteoarthritis (KOA). The stage must be radiographically confirmed (Kellgren-Lawrence grade II or III) within 6 months prior to study entry.
- Persistent pain reported during the 3 months prior to recruitment and moderate to severe pain when walking on inclines or stairs, or at rest (VAS score ≥40) at baseline.
- History of analgesic use (paracetamol and/or NSAIDs) related to the study condition.
- Willingness and ability to complete questionnaires and understand study instructions.
- Signed informed consent specific to the study.
Exclusion
- X-rays showing grade IV changes on the Kellgren-Lawrence scale.
- Severe functional impairment in the knee.
- Bilateral involvement (simultaneous involvement of both knees).
- Associated hip osteoarthritis.
- Clinically significant pain in joints other than the knee.
- Psoriasis.
- Patients with confirmed rheumatic joint disease.
- Active infection.
- Known or suspected use of intra-articular steroids within the previous 3 months, or intra-articular HA or PRP within the 9 months prior to treatment initiation, as well as the use of chondroprotective agents.
- Pregnant women.
Key Trial Info
Start Date :
June 2 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 14 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06975631
Start Date
June 2 2022
End Date
February 14 2024
Last Update
May 21 2025
Active Locations (1)
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1
University Hospital of Álava
Vitoria-Gasteiz, Álava, Spain, 01009