Clinical Efficacy and Safety of NEOIAL HC for Intra-articular Use in the Treatment of Severe Knee Osteoarthritis

Nextrasearch S.r.l.s.

Status and phase

Completed

Phase 4

Conditions

Osteoarthritis of Knee

Treatments

Device: Neoial HC

Study type

Interventional

Funder types

Other

Identifiers

NCT05936762

NeoialHC

Details and patient eligibility

About

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

Enrollment

15 patients

Sex

All

Ages

50 to 80 years old

Volunteers

Accepts Healthy Volunteers

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.