Clinical trial NCT06975631: Post-market Study on TrHCROSS® in Knee Osteoarthritis After a Single Injection
Official title: Post-market Study for the Evaluation of the Effectiveness and Safety of Treatment With TrHCROSS by i+Med in Knee Osteoarthritis After a Single Intra-articular Administration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: KOA
Osteoarthritis
Knee
Sodium Hyaluronate
WOMAC
VAS
KOOS
Lead sponsor: i+Med S.Coop.
Sponsor class: INDUSTRY
Collaborators: name: Hospital Universitario Araba
name: Bioaraba
First posted: 2025-05-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Non-inferiority, controlled, interventional, randomized, parallel-group, single-blind, and single-center clinical trial
Primary purpose: TREATMENT

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 patients with mild to moderate KOA (Kellgren-Lawrence II or III) who have not responded adequately to non-pharmacological treatments or simple analgesics.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Evaluate the effectiveness of TrHCROSS® for pain relief in patients with KOA.
timeFrame: In 24 weeks.
measure: Serious adverse events.
timeFrame: Through study completion, approximately 52 weeks.
Secondary outcomes:
measure: Pain relief using WOMAC A.
timeFrame: At the conclusion of the study, approximately 52 weeks later.
measure: Stiffness using WOMAC B.
timeFrame: In 24 weeks and in 52 weeks.
measure: Functionality using WOMAC C.
timeFrame: In 24 weeks and in 52 weeks.
measure: Global Patient Assessment.
timeFrame: In 24 weeks and in 52 weeks.
measure: Combined WOMAC and VAS scales.
timeFrame: At baseline, in 24 weeks and in 52 weeks.
measure: Improvement in pain score.
timeFrame: At baseline, in 24 weeks and in 52 weeks.
measure: Improvement in KOOS scores.
timeFrame: At baseline, in 24 weeks and in 52 weeks.
measure: Treatment response rate.
timeFrame: At baseline, in 24 weeks and in 52 weeks.
measure: Patient satisfaction with treatment.
timeFrame: At the conclusion of the study, approximately 52 weeks later.
measure: Other adverse events.
timeFrame: Through study completion, approximately 52 weeks.
measure: Analgesic use.
timeFrame: Through study completion, approximately 52 weeks.
measure: Joint mobility.
timeFrame: At baseline, in 24 weeks and in 52 weeks.
measure: Investigator´s global assessment.
timeFrame: At the conclusion of the study, approximately 52 weeks later.
Other outcomes:
Locations:
city: Vitoria-Gasteiz
country: Spain
facility: University Hospital of Álava
state: Álava
Study officials:
References: