Hip Viscosupplementation: What is the Best Dosage?

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01810809

Acronym

Hip VS

Enrollment

Registered

2013-03-14

Start date

2013-04-30

Completion date

2014-11-30

Last updated

2013-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis

Keywords

Osteoarthritis, Hip, Viscosupplementation, Clinical Trial

Brief summary

Intraarticular injections have long been used to treat osteoarthritis. Viscosupplementation is a relatively new approach comprising the injection of hyaluronic acid into diarthrodial joints. The dosis regimen is well established for the knee joint, but there is still no consensus regarding the optimal dosage for hip viscosupplementation. Our objective is to determine the optimal dosis for hip viscosupplementation

Detailed description

Intraarticular injections have long been used to treat osteoarthritis. Viscosupplementation is a relatively new approach comprising the injection of hyaluronic acid into diarthrodial joints. Any osteoarthritic joint is eligible to this treatment modality, but the great majority of studies are for knee viscosupplementation. The dosis regimen is well established for the knee joint, but there is still no consensus regarding the optimal dosage for hip viscosupplementation. We will prospectively enroll 80 patients with hip osteoarthritis and will randomize them into four groups: Group zero will receive joint lavage with saline injection. Group 1 will receive joint lavage with saline injection and 2 ml of Hylan GF-20 (1 ampoule of Synvisc Classic®). Group 2 will receive joint lavage with saline injection and 4 ml of Hylan GF-20 (2 ampoules of Synvisc Classic®). Group 3 will receive joint lavage with saline injection and 6 ml of Hylan GF-20 (3 ampoules of Synvisc Classic®). The Visual Analogic Scale of Pain (VAS), the Western Ontario and McMaster Universities Index (WOMAC®), and Lequesne questionnaires were completed at baseline and at Weeks 1, 4, 12, and 24. Our objective is to determine the optimal dosis for hip viscosupplementation

Interventions

PROCEDUREarticular lavage with saline injection

Patients will receive articular lavage with saline injection

DRUG1 ampoule of Hylan GF-20

Patients will receive viscosupplementation with 2ml (1 ampoule) of Hylan GF-20

DRUG2 ampoules of Hylan GF-20

Patients will receive viscosupplementation with 4ml (2 ampoules) of Hylan GF-20

DRUG3 ampoules of Hylan GF-20

Patients will receive viscosupplementation with 6ml (3 ampoules) of Hylan GF-20

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

Healthy volunteers

Inclusion criteria

* Met the American College of Rheumatology criteria for hip osteoarthritis * No hip intraarticular injections in the last 6 months

Exclusion criteria

\- Severe reaction to the procedure

Design outcomes

Primary

Measure	Time frame	Description
Lequesne	6 months	Pain and function assessment with Lequesne questionaire
WOMAC	6 months	Pain and function assessment with WOMAC questionaire
VAS	6 months	Pain assessment with Visual Analogic Scale (VAS)

Countries

Brazil

Contacts

Primary ContactGustavo C de Campos, MD

gustavoccampos@terra.com.br+551983318000

Backup ContactMarcia U Rezende, PhD

murezende@uol.com.br+5511981226282

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026