Hip Viscosupplementation: What is the Best Dosage?
Hip VS
1 other identifier
interventional
80
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Apr 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 11, 2013
CompletedFirst Posted
Study publicly available on registry
March 14, 2013
CompletedStudy Start
First participant enrolled
April 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2014
CompletedSeptember 11, 2013
September 1, 2013
1.2 years
March 11, 2013
September 10, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
WOMAC
Pain and function assessment with WOMAC questionaire
6 months
VAS
Pain assessment with Visual Analogic Scale (VAS)
6 months
Lequesne
Pain and function assessment with Lequesne questionaire
6 months
Study Arms (4)
Articular Lavage
ACTIVE COMPARATORPatients from Group Zero will receive articular lavage with saline injection
Group 1
EXPERIMENTALPatients from Group 1 will receive articular lavage with saline injection and viscosupplementation with 2ml (1 ampoule) of Hylan GF-20
Group 2
EXPERIMENTALPatients from Group 2 will receive articular lavage with saline injection and viscosupplementation with 4ml (2 ampoules) of Hylan GF-20
Group 3
EXPERIMENTALPatients from Group 3 will receive articular lavage with saline injection and viscosupplementation with 6ml (3 ampoules) of Hylan GF-20
Interventions
Patients will receive articular lavage with saline injection
Patients will receive viscosupplementation with 2ml (1 ampoule) of Hylan GF-20
Patients will receive viscosupplementation with 4ml (2 ampoules) of Hylan GF-20
Patients will receive viscosupplementation with 6ml (3 ampoules) of Hylan GF-20
Eligibility Criteria
You may qualify if:
- Met the American College of Rheumatology criteria for hip osteoarthritis
- No hip intraarticular injections in the last 6 months
You may not qualify if:
- \- Severe reaction to the procedure
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Instituto de Ortopedia e Traumatologia HC-FMUSP
São Paulo, São Paulo, 05410-000, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gustavo C de Campos, MD
FMUSP
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 11, 2013
First Posted
March 14, 2013
Study Start
April 1, 2013
Primary Completion
June 1, 2014
Study Completion
November 1, 2014
Last Updated
September 11, 2013
Record last verified: 2013-09