Clinical trial NCT05936762: Clinical Efficacy and Safety of NEOIAL HC for Intra-articular Use in the Treatment of Severe Knee Osteoarthritis
Official title: Clinical Efficacy and Safety of NEOIAL HC (Hyaluronic Acid + Collagen) for Intra-articular Use in the Treatment of Severe Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoarthritis of Knee
Keywords: Osteoarthritis
knee
hyaluronic
collagen
neoial
gonarthrosis
Lead sponsor: Nextrasearch S.r.l.s.
Sponsor class: OTHER
First posted: 2023-07-10
Enrollment: 15
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Of the 36 screened patients, 15 had to be included and treated patients (15 as planned per-protocol). Of these, 14 patients completed the study and attended the visit at Month 6 . Since all patients were treated , the Full Analysis Set (FAS, all randomized and treated patients) was identical to the Safety Set (all treated patients).

The mean age at enrollment was 71±7 years (range 54-80;median 73), and 12 of patients were women (85.7%) and 2 male (14.3%) . The mean BMI were26.6±3.4 (range 21-30;median 28.5) . Overall patients had knee OA with a Kellgren-Lawrence grade II and III (50/50).
Primary purpose: TREATMENT

Brief summary: Osteoarthritis (OA) is one of the most frequent causes of pain and disability in adults. According to the Osteoarthritis Research Society International (OARSI), at least 40% of people over the age of 65 suffer from symptomatic osteoarthritis of the hip or knee. Knee osteoarthritis (OA) is the eleventh leading cause of years lived with disability according to the World Health Organization.

The guidelines show that treatment with intra-articular injections of hyaluronic acid (HA) leads to a slow, prolonged pain relief (up to six months after the first injection); On the other hand, there is little evidence in the literature about the intra-articular use of isolated collagen or in combination with hyaluronic acid in the treatment of knee osteoarthritis.

The present study showed a clinically good safety profile and provided preliminary evidence of the efficacy of NEOIAL HC for the treatment of symptomatic knee OA


Eligibility criteria: Inclusion Criteria:

* Age
* Knee OA
* VAS \> 3
* Kellegren radiographic stage 3-4

Exclusion Criteria:

* presence of joint effusion,
* VAS score \<3 according to the American College of Rheumatology Criteria
* neoplasms,
* haematological diseases,
* specific rheumatological pathologies,
* bleeding disorders, local infections,
* refusal or non-compliance of the patient,
* candidacy for knee joint replacement or any intra-articular injection during the previous year,
* addiction to opioid drugs,
* recent heart attack or stroke.

Primary outcomes:
measure: VAS score
timeFrame: 6 months
Secondary outcomes:
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: 6 months
measure: Lequesne
timeFrame: 6 months
measure: Western Ontario McMaster Universities (WOMAC®) VA3.1
timeFrame: 6 months
Other outcomes:
measure: occurrence of AEs and serious adverse events (SAEs)
timeFrame: through study completion, an average of 1 year
Locations:
city: Chieti
country: Italy
facility: Ospedale SS Annunziata
Study officials:
affiliation: Ospedale Santa Annunziata di Chieti
name: Roberto Buda, Prof
role: PRINCIPAL_INVESTIGATOR
References: