6-month Efficacy and Safety of Synolis VA 80/160 in Hip Osteoarthritis

Aptissen

Status

Enrolling

Conditions

Osteoarthritis, Hip

Treatments

Device: SYNOLIS VA 80/160

Study type

Interventional

Funder types

Industry

Identifiers

PMCF A-SYN400 Hip

Details and patient eligibility

About

Multicenter, independent study of Synolis VA 80/160 over a period of 6 months

Enrollment

70 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patient over 18 years of age,
Patient with osteoarthritis of the hip. The diagnosis is based on the following criteria:
Treated hip pain: Oxford score ≥ 21/60,
Kellgren-Lawrence positive X-ray stage: II - III (inclusion radiograph dated no more than 6 months before the inclusion visit),
Symptoms related to osteoarthritis of the hip for at least 2 months,
Failure of treatments (i.e., inadequate or ineffective response to analgesics and/or NSAIDs or intolerance to NSAIDs or low-grade opioids (leaving an OXFORD score ≥ 21/60),
Informed consent form signed by the patient,
The patient has never had a visco supplement injection or corticosteroid injection in the hip to be treated (or more than 6 months old).

Exclusion criteria

Pregnancy,
Participation in another clinical trial,
Skin lesion near the injection site,
Recent or old infection of the affected joint,
Patient with a programmed arthroplasty,
Patient with a pathology that makes decision-making impossible,
The patient must not have undergone non-prosthetic hip-conserving surgery such as osteotomy or arthroscopy less than 12 months old.