Osteoarthritis of the KneePhase 4NCT03090698
Outcomes of Injections in Patients Waiting for Total Knee Replacement
A Phase 4 study testing Hylan G-F 20 and Triamcinolone in people with Osteoarthritis of the Knee, run by Universidade Federal Fluminense at 1 site in Brazil.
Trial summary
A comparison of intraarticular administration of Hylan GF20, Triamcinolone and both associated in patients with severe osteoarthritis of the knee with follow up of one, three and six months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis of the Knee
- What is being tested?
- Hylan G-F 20 and Triamcinolone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2015to Jun 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 18 years old;
- Waiting for Total Knee Arthroplasty (at Hospital Federal dos Servidores queue);
- Acceptance and signature of the TFCC;
Who cannot join
- Infiltration of the knee for the past 6 months;
- Allergic to any substance used in the study;
- Prior infection in the knee.
Trial locations and contacts
1 site in 1 country.
Vinicius Gameiro contact
Brazil1 site, 1 recruiting
- Recruiting
Hospital dos Servidores do Estado do Rio de Janeiro
Rio de Janeiro, Rio de Janeiro, 20.221-903
Andre Campos, +55 21 22913131 ext. 3374, andresiqueiracampos@hotmail.com
About this study
Official title: Viscosupplementation in Patients With Severe Osteoarthritis of the Knee
A comparison of intraarticular administration of Hylan GF20, Triamcinolone and both associated in patients with severe osteoarthritis of the knee with follow up of one, three and six months.
Read the detailed description
The objective of this research is to evaluate the short-term results of viscosupplementation in patients with advanced osteoarthritis of the knee.
There is a bigger demand of patients requiring total knee arthroplasty than the number of surgeries performed by the Unified Health System in Brazil. For this reason the queues to perform this surgery are huge and time-consuming in the referral hospitals. Whereas all these patients are suffering from severe pain and limiting, and awaiting the surgery for a few years, it is necessary to try any treatment, even if temporary, to ease the pain and suffering of those patients.
A double-blind randomized prospective study will be held at Hospital Federal dos Servidores do Estado do Rio de Janeiro, with patients from the waiting list for Total Knee Arthroplasty who accept to participate and sign the informed consent form. Will be selected the last 150 knees in TKA queue. Patients will be randomized and divided in 3 groups of 50 knees. A group will be submitted to an intraarticular injection of corticosteroid (1 ml of sterile Triamcinolone Hexacetonide solution 20 mg/ml). A second group will be subjected to administration of 6 ml of Hylan GF20. The third group will receive Hylan GF20 associated with corticosteroid (7 ml solution containing 1 ml of triamcinolone and 6 ml of Hylan GF20). The injection technique will be the same for all patients. The outcome results will be measured by a form with patient data, functional scores (Knee Society Score and Lysholm) before treatment and at one, three and six months after treatment.
- Conditions
- Osteoarthritis of the Knee
- Being tested
- Hylan G-F 20, Triamcinolone
- Keywords
- osteoarthritis, knee, treatment
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hylan G-F 20Drug
intra-articular administration
TriamcinoloneDrug
Intra-articular administration
| Study group | Role | What they receive |
|---|---|---|
| Hylan | Active comparator | Intra-articular (knee) 6ml Hylan GF20 administration (single shot) Receives: Drug: Hylan G-F 20 |
| Hylan + Corticosteroid | Active comparator | Intra-articular (knee) 6ml Hylan GF20 and 1ml Triamcinolone 20mg/ml administration (single shot) Receives: Drug: Hylan G-F 20; Drug: Triamcinolone |
| Corticosteroid | Active comparator | Intra-articular (knee) 1ml Triamcinolone administration (single shot) Receives: Drug: Triamcinolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lysholm M1
The outcome will be measured by Lysholm Score within one month. The results will be compared within each group from baseline and between the 3 groups.
Measured: One month
KSS M1
The outcome will be measured by Knee Society Score within one month. The results will be compared within each group from baseline and between the 3 groups.
Measured: One month
Secondary outcomes (4)
Lysholm M3
The outcome will be measured by Lysholm Score within three months. The results will be compared within each group from baseline and between the 3 groups.
Measured: Three months
KSS M3
The outcome will be measured by Knee Society Score within three months. The results will be compared within each group from baseline and between the 3 groups.
Measured: Three months
Lysholm M6
The outcome will be measured by Lysholm Score within six months. The results will be compared within each group from baseline and between the 3 groups.
Measured: Six months
KSS M6
The outcome will be measured by Knee Society Score within six months. The results will be compared within each group from baseline and between the 3 groups.
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2017
- Study startSep 2015
- Primary completionApr 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis of the KneeStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal Fluminense
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vinicius Schott Gameiro, Universidade Federal Fluminense
- Investigators
- Andre Campos, Principal investigator, Hospital dos Servidores do Estado
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03090698
- Sponsor's protocol ID
- VISCO KNEE UFF
- Status last verified
- Mar 2017
- First submitted
- 2 Mar 2017
- Last updated
- 27 Mar 2017
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Viscosupplementation in Patients With Severe Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT03090698
- Acronym / sponsor ID
- VISCO KNEE UFF
- Conditions
- Osteoarthritis of the Knee
- Keywords
- osteoarthritis, knee, treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Universidade Federal FluminenseUniversity, hospital or other
- Study start
- Sep 2015 (actual)
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 27 Mar 2017 (actual)
- 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.
A comparison of intraarticular administration of Hylan GF20, Triamcinolone and both associated in patients with severe osteoarthritis of the knee with follow up of one, three and six months.
Detailed description
The objective of this research is to evaluate the short-term results of viscosupplementation in patients with advanced osteoarthritis of the knee.
There is a bigger demand of patients requiring total knee arthroplasty than the number of surgeries performed by the Unified Health System in Brazil. For this reason the queues to perform this surgery are huge and time-consuming in the referral hospitals. Whereas all these patients are suffering from severe pain and limiting, and awaiting the surgery for a few years, it is necessary to try any treatment, even if temporary, to ease the pain and suffering of those patients.
A double-blind randomized prospective study will be held at Hospital Federal dos Servidores do Estado do Rio de Janeiro, with patients from the waiting list for Total Knee Arthroplasty who accept to participate and sign the informed consent form. Will be selected the last 150 knees in TKA queue. Patients will be randomized and divided in 3 groups of 50 knees. A group will be submitted to an intraarticular injection of corticosteroid (1 ml of sterile Triamcinolone Hexacetonide solution 20 mg/ml). A second group will be subjected to administration of 6 ml of Hylan GF20. The third group will receive Hylan GF20 associated with corticosteroid (7 ml solution containing 1 ml of triamcinolone and 6 ml of Hylan GF20). The injection technique will be the same for all patients. The outcome results will be measured by a form with patient data, functional scores (Knee Society Score and Lysholm) before treatment and at one, three and six months after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hylan | Active comparator | Drug: Hylan G-F 20Intra-articular (knee) 6ml Hylan GF20 administration (single shot) |
| Hylan + Corticosteroid | Active comparator | Drug: Hylan G-F 20, Drug: TriamcinoloneIntra-articular (knee) 6ml Hylan GF20 and 1ml Triamcinolone 20mg/ml administration (single shot) |
| Corticosteroid | Active comparator | Drug: TriamcinoloneIntra-articular (knee) 1ml Triamcinolone administration (single shot) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Over 18 years old;
- Waiting for Total Knee Arthroplasty (at Hospital Federal dos Servidores queue);
- Acceptance and signature of the TFCC;
Key exclusion criteria (3 listed)
- Infiltration of the knee for the past 6 months;
- Allergic to any substance used in the study;
- Prior infection in the knee.
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 |
|---|---|---|
| Hylan G-F 20intra-articular administration | Drug | Hylan, Hylan + Corticosteroid |
| TriamcinoloneIntra-articular administration | Drug | Corticosteroid, Hylan + Corticosteroid |
Primary outcome
Lysholm M1
Time frame: One month
The outcome will be measured by Lysholm Score within one month. The results will be compared within each group from baseline and between the 3 groups.
KSS M1
Time frame: One month
The outcome will be measured by Knee Society Score within one month. The results will be compared within each group from baseline and between the 3 groups.
4 secondary outcomes
Lysholm M3
Time frame: Three months
KSS M3
Time frame: Three months
Lysholm M6
Time frame: Six months
KSS M6
Time frame: Six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2017.
- Individual participant dataSharing planned: Undecided
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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.
Vinicius Gameiro contact
Andre Campos principal investigator
Hospital dos Servidores do Estado
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 Hylan G-F 20 and Triamcinolone in people with Osteoarthritis of the Knee, run by Universidade Federal Fluminense 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 3 inclusion and 3 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 27 Mar 2017. 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 Andre Campos (+55 21 22913131 ext. 3374, andresiqueiracampos@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lysholm M1 (time frame: One month). The study lists 2 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 27 Mar 2017.