Knee OsteoarthritisPhase 4NCT01874574
Intra-articular Corticosteroid Injection Compared With Single-Shot Hyaluronic Acid for Treatment of Osteoarthritis Knee
A Phase 4 study testing Hylan G-F 20 and Corticosteroid in people with Knee Osteoarthritis, run by Thammasat University at 1 site in Thailand.
Trial summary
Corticosteroid and Hylan G-F 20 are both effective in improving pain and function of osteoarthritic knee patients. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Hylan G-F 20 and Corticosteroid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteThailand
- Study dates
- Jan 2011to Sep 2013
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of knee OA
- Knee pain for most days of the prior month
- Radiographic evidence consistent with knee OA
- Aged between 40 and 80 years old
Who cannot join
- Lumbar spondylosis
- Gross deformity of the knee
- Co-existent inflammatory or crystal arthritis
- Prior knee surgery
- Injury to the knee in the preceding 6 months
- Any intra-articular injection in the preceding 3 months
Show all 9Show fewer
- Pregnant or Lactating
- Current infection in the affected knee
- Inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Thammasat University Hospital, Thammasat University
Prathumthani, Changwat Pathum Thani, 12121
About this study
Official title: Intra-articular Corticosteroid Injection Compared With Single-Shot Hyaluronic Acid for Treatment of Osteoarthritis Knee: A Prospective, Double-blind Randomized Controlled Trial
Corticosteroid and Hylan G-F 20 are both effective in improving pain and function of osteoarthritic knee patients.
Read the detailed description
Corticosteroid and Hylan G-F 20 are both effective in improving pain and function of osteoarthritic knee patients up to 6 months.
- Conditions
- Knee Osteoarthritis
- Being tested
- Hylan G-F 20, Corticosteroid
- Keywords
- Knee Osteoarthritis, Corticosteroid, Hyaluronic acid, Intra-articular injection
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hylan G-F 20Drug
Also called Synvisc
After full aseptic preparation, Single shot intra-articular injection either 6 mL of Hylan G-F 20 or 1 mL of 40 mg triamcinolone acetonide plus 5 mL of 1% xylocaine with adrenaline were injected into the joint cavity using the infero-lateral approach via a 21-gauge needle.
CorticosteroidDrug
Also called Triamcinolone acetonide
After full aseptic preparation, Single shot intra-articular injection either 6 mL of Hylan G-F 20 or 1 mL of 40 mg triamcinolone acetonide plus 5 mL of 1% xylocaine with adrenaline were injected into the joint cavity using the infero-lateral approach via a 21-gauge needle.
| Study group | Role | What they receive |
|---|---|---|
| Single shot Hylan G-F 20 (Synvisc) | Experimental | Intra-articular injection of the Single shot 6 mL of Hylan G-F 20 (Synvisc) Receives: Drug: Hylan G-F 20 |
| Corticosteroid (Triamcinolone acetonide) | Active comparator | Intra-articular injection of 1 mL of 40 mg Triamcinolone acetonide plus 5 mL of 1% xylocaine with adrenaline injected at the knee by single shot Receives: Drug: Corticosteroid |
What is being measured
The primary outcome is the main question the study is designed to answer.
WOMAC Score
Change from Baseline in WOMAC score at 6 months
Measured: 6 months
Secondary outcomes (1)
Visual Analogue Scale(VAS)
Change from Baseline in VAS score at 6 months
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 posted11 Jun 2013 (estimated)
- Study startJan 2011
- Primary completionJun 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thammasat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Phonthakorn Panichkul, Thammasat University
- Investigators
- Nattapol Tammachote, MD, MSc, Study director, Department of Orthopaedics, Thammasat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01874574
- Sponsor's protocol ID
- OrthoTU-01
- Status last verified
- Apr 2014
- First submitted
- 5 Sep 2012
- Last updated
- 22 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-articular Corticosteroid Injection Compared With Single-Shot Hyaluronic Acid for Treatment of Osteoarthritis Knee: A Prospective, Double-blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01874574
- Acronym / sponsor ID
- OrthoTU-01
- Conditions
- Knee Osteoarthritis
- Keywords
- Knee Osteoarthritis, Corticosteroid, Hyaluronic acid, Intra-articular injection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Thammasat UniversityUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 11 Jun 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.
Corticosteroid and Hylan G-F 20 are both effective in improving pain and function of osteoarthritic knee patients.
Detailed description
Corticosteroid and Hylan G-F 20 are both effective in improving pain and function of osteoarthritic knee patients up to 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single shot Hylan G-F 20 (Synvisc) | Experimental | Drug: Hylan G-F 20Intra-articular injection of the Single shot 6 mL of Hylan G-F 20 (Synvisc) |
| Corticosteroid (Triamcinolone acetonide) | Active comparator | Drug: CorticosteroidIntra-articular injection of 1 mL of 40 mg Triamcinolone acetonide plus 5 mL of 1% xylocaine with adrenaline injected at the knee by single shot |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical diagnosis of knee OA
- Knee pain for most days of the prior month
- Radiographic evidence consistent with knee OA
- Aged between 40 and 80 years old
Key exclusion criteria (9 listed)
- Lumbar spondylosis
- Gross deformity of the knee
- Co-existent inflammatory or crystal arthritis
- Prior knee surgery
- Injury to the knee in the preceding 6 months
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 20Also: SynviscAfter full aseptic preparation, Single shot intra-articular injection either 6 mL of Hylan G-F 20 or 1 mL of 40 mg triamcinolone acetonide plus 5 mL of 1% xylocaine with adrenaline were injected into the joint cavity using the infero-lateral approach via a 21-gauge needle. | Drug | Single shot Hylan G-F 20 (Synvisc) |
| CorticosteroidAlso: Triamcinolone acetonideAfter full aseptic preparation, Single shot intra-articular injection either 6 mL of Hylan G-F 20 or 1 mL of 40 mg triamcinolone acetonide plus 5 mL of 1% xylocaine with adrenaline were injected into the joint cavity using the infero-lateral approach via a 21-gauge needle. | Drug | Corticosteroid (Triamcinolone acetonide) |
Primary outcome
WOMAC Score
Time frame: 6 months
Change from Baseline in WOMAC score at 6 months
1 secondary outcome
Visual Analogue Scale(VAS)
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2014.
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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.
Nattapol Tammachote, MD, MSc study director
Department of Orthopaedics, Thammasat University
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 Corticosteroid in people with Knee Osteoarthritis, run by Thammasat University at 1 site in Thailand.
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 4 inclusion and 9 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: finished, as of the sponsor's last update on 22 Apr 2014. 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 Thailand. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
WOMAC Score (time frame: 6 months). 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 22 Apr 2014.