OsteoarthritisPhase 4Hip VSNCT01810809
Hip Viscosupplementation: What is the Best Dosage?
A Phase 4 study testing articular lavage with saline injection, 1 ampoule of Hylan GF-20 and 2 ampoules of Hylan GF-20 in people with Osteoarthritis, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- articular lavage with saline injection, 1 ampoule of Hylan GF-20 and 2 ampoules of Hylan GF-20
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2013to Nov 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Met the American College of Rheumatology criteria for hip osteoarthritis
- No hip intraarticular injections in the last 6 months
Who cannot join
- Severe reaction to the procedure
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Instituto de Ortopedia e Traumatologia HC-FMUSP
São Paulo, São Paulo, 05410-000
Valquiria, +551126616888
Marcia U Rezende, Phd
About this study
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
Read the 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
- Conditions
- Osteoarthritis
- Being tested
- articular lavage with saline injection, 1 ampoule of Hylan GF-20, 2 ampoules of Hylan GF-20, 3 ampoules of Hylan GF-20
- Keywords
- Osteoarthritis, Hip, Viscosupplementation, Clinical Trial
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
articular lavage with saline injectionProcedure or surgery
Patients will receive articular lavage with saline injection
1 ampoule of Hylan GF-20Drug
Also called 1 ampole of Synvisc Classic
Patients will receive viscosupplementation with 2ml (1 ampoule) of Hylan GF-20
2 ampoules of Hylan GF-20Drug
Also called 2 ampoles of Synvisc Classic
Patients will receive viscosupplementation with 4ml (2 ampoules) of Hylan GF-20
3 ampoules of Hylan GF-20Drug
Also called 3 ampoules of Synvisc Classic
Patients will receive viscosupplementation with 6ml (3 ampoules) of Hylan GF-20
| Study group | Role | What they receive |
|---|---|---|
| Articular Lavage | Active comparator | Patients from Group Zero will receive articular lavage with saline injection Receives: Procedure: articular lavage with saline injection |
| Group 1 | Experimental | Patients from Group 1 will receive articular lavage with saline injection and viscosupplementation with 2ml (1 ampoule) of Hylan GF-20 Receives: Procedure: articular lavage with saline injection; Drug: 1 ampoule of Hylan GF-20 |
| Group 2 | Experimental | Patients from Group 2 will receive articular lavage with saline injection and viscosupplementation with 4ml (2 ampoules) of Hylan GF-20 Receives: Procedure: articular lavage with saline injection; Drug: 2 ampoules of Hylan GF-20 |
| Group 3 | Experimental | Patients from Group 3 will receive articular lavage with saline injection and viscosupplementation with 6ml (3 ampoules) of Hylan GF-20 Receives: Procedure: articular lavage with saline injection; Drug: 3 ampoules of Hylan GF-20 |
What is being measured
The primary outcome is the main question the study is designed to answer.
WOMAC
Pain and function assessment with WOMAC questionaire
Measured: 6 months
VAS
Pain assessment with Visual Analogic Scale (VAS)
Measured: 6 months
Lequesne
Pain and function assessment with Lequesne questionaire
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2013 (estimated)
- Study startApr 2013
- Primary completionJun 2014 (estimated)
- Study completionNov 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gustavo C de Campos, MD, Principal investigator, FMUSP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01810809
- Sponsor's protocol ID
- 0255/10
- Acronym
- Hip VS
- Status last verified
- Sep 2013
- First submitted
- 11 Mar 2013
- Last updated
- 11 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hip Viscosupplementation: What is the Best Dosage?
- ClinicalTrials.gov ID
- NCT01810809
- Acronym / sponsor ID
- Hip VS / 0255/10
- Conditions
- Osteoarthritis
- Keywords
- Osteoarthritis, Hip, Viscosupplementation, Clinical Trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Nov 2014 (estimated)
- First posted
- 14 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Articular Lavage | Active comparator | Procedure: articular lavage with saline injectionPatients from Group Zero will receive articular lavage with saline injection |
| Group 1 | Experimental | Procedure: articular lavage with saline injection, Drug: 1 ampoule of Hylan GF-20Patients from Group 1 will receive articular lavage with saline injection and viscosupplementation with 2ml (1 ampoule) of Hylan GF-20 |
| Group 2 | Experimental | Procedure: articular lavage with saline injection, Drug: 2 ampoules of Hylan GF-20Patients from Group 2 will receive articular lavage with saline injection and viscosupplementation with 4ml (2 ampoules) of Hylan GF-20 |
| Group 3 | Experimental | Procedure: articular lavage with saline injection, Drug: 3 ampoules of Hylan GF-20Patients from Group 3 will receive articular lavage with saline injection and viscosupplementation with 6ml (3 ampoules) of Hylan GF-20 |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Met the American College of Rheumatology criteria for hip osteoarthritis
- No hip intraarticular injections in the last 6 months
Key exclusion criteria (1 listed)
- Severe reaction to the procedure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| articular lavage with saline injectionPatients will receive articular lavage with saline injection | Procedure or surgery | Articular Lavage, Group 1, Group 2, Group 3 |
| 1 ampoule of Hylan GF-20Also: 1 ampole of Synvisc ClassicPatients will receive viscosupplementation with 2ml (1 ampoule) of Hylan GF-20 | Drug | Group 1 |
| 2 ampoules of Hylan GF-20Also: 2 ampoles of Synvisc ClassicPatients will receive viscosupplementation with 4ml (2 ampoules) of Hylan GF-20 | Drug | Group 2 |
| 3 ampoules of Hylan GF-20Also: 3 ampoules of Synvisc ClassicPatients will receive viscosupplementation with 6ml (3 ampoules) of Hylan GF-20 | Drug | Group 3 |
Primary outcome
WOMAC
Time frame: 6 months
Pain and function assessment with WOMAC questionaire
VAS
Time frame: 6 months
Pain assessment with Visual Analogic Scale (VAS)
Lequesne
Time frame: 6 months
Pain and function assessment with Lequesne questionaire
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gustavo C de Campos, MD principal investigator
FMUSP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing articular lavage with saline injection, 1 ampoule of Hylan GF-20 and 2 ampoules of Hylan GF-20 in people with Osteoarthritis, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gustavo C de Campos, MD (+551983318000, gustavoccampos@terra.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
WOMAC (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2013.