Knee OsteoarthritisPhase 2NCT01267214

The Efficacy and Safety of Intraarticular Sodium Hyaluronate (Hyalgan) After Proximal Tibial Osteotomy in Treatment of Knee Osteoarthritis Patients

A Phase 2 study testing Sodium Hyaluronate (Hyalgan) and Osteotomy alone in people with Knee Osteoarthritis, run by TRB Chemedica at 1 site in Thailand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to assess the efficacy and safety of Hyalgan after proximal tibial osteotomy in treatment of knee osteoarthritis patients. Normally, OA patients who were treated with osteotomy will not be treated with any SYSADOA after operation, even though their cartilage's not completely loss, so… Read more about this study

Who is it for?: Ages 35 to 65 years
Conditions the study is for: Knee Osteoarthritis
What is being tested?: Sodium Hyaluronate (Hyalgan) and Osteotomy alone
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteThailand
Study dates: Feb 2009to Jul 2011
Phase: Phase 2
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 35 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients between 35 and 65 years with primary knee OA with malalignment
Mild to moderate OA of grade II or III severity on the Kellgren-Lawrence scale with require treatment by osteotomy
Malalignment is not exceed 15 degree (+,-)
Pain on walking (15 m) ≥ 40 mm.
Range of motion > 90 degree
Evidence of adequate contraceptive methods in women of childbearing age

Who cannot join

Previous surgery on affected knee
Previous intraarticular intervention within the last 3 months (eg. Steroid, anaesthetic, Sodium hyaluronate)
Oral SYSADOA treatment (chondroitin, glucosamine, diacerein) within 2 months prior to study start
Known or suspected infection of the affected joint
Painful knee condition due to another cause than chondral lesions, such as Sudeck's atrophy, intraarticular neoplasm, pigmented villonodular synovitis, chondromatosis
Poor general health or other conditions which would make regular hospital attendance difficult

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Ascertained hypersensitivity to any component used in the study (eg. Hyaluronic acid, diclofenac, morphine, omeprazole and paracetamol)
Hypersensitivity to avian protein
Ongoing or previous participation in a clinical study within the last 3 months

Trial locations and contacts

1 site in 1 country.

Thailand1 site

Siriraj Hospital, Faculty of Medicine, Mahidol university
Bangkok, Bangkok, 10700

Other trials in Thailand

About this study

Conditions: Knee Osteoarthritis
Being tested: Sodium Hyaluronate (Hyalgan), Osteotomy alone
Medical subject headings: Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Sodium Hyaluronate (Hyalgan)Drug
1% Sodium Hyaluronate in prefilled syringe
Osteotomy aloneProcedure or surgery
no injection

Study groups in NCT01267214
Study group	Role	What they receive
Osteotomy plus Hyalgan	Experimental	Osteotomy at Week 0 Hyalgan injection at Week 2, 3, 4, 5, 6, 24, 25, 26, 27, 28 Receives: Drug: Sodium Hyaluronate (Hyalgan)
Osteotomy alone	Other	Not described Receives: Procedure: Osteotomy alone

What is being measured

The primary outcome is the main question the study is designed to answer.

Joint Space Width
Measured: 12 months
Global assessment
assess by Patient and investigator
Measured: 12 months
WOMAC section A, B, C
Pain score
Measured: 12 months
Rescue medicine consumption
Diclofenac consumption
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2009Jul 2011

First posted28 Dec 2010 (estimated)
Study startFeb 2009
Primary completionFeb 2010
Study completionJul 2011

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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01267214
Sponsor's protocol ID: HGN-THA-08-01
Status last verified: Nov 2012
First submitted: 23 Dec 2010
Last updated: 21 Nov 2012
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Holistic Healing for Knee Osteoarthritis
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Effect of Anti-inflammatory Diet in Osteoarthritis
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Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
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The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
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RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis

All Knee Osteoarthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Efficacy and Safety of Intraarticular Sodium Hyaluronate (Hyalgan) After Proximal Tibial Osteotomy in Treatment of Knee Osteoarthritis Patients
ClinicalTrials.gov ID: NCT01267214
Acronym / sponsor ID: HGN-THA-08-01
Conditions: Knee Osteoarthritis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: TRB ChemedicaIndustry (pharma, biotech, devices)
Study start: Feb 2009
Primary completion: Feb 2010 (actual)
Study completion: Jul 2011 (actual)
First posted: 28 Dec 2010 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Osteotomy plus Hyalgan	Experimental	Drug: Sodium Hyaluronate (Hyalgan)Osteotomy at Week 0 Hyalgan injection at Week 2, 3, 4, 5, 6, 24, 25, 26, 27, 28
Osteotomy alone	Other	Procedure: Osteotomy alone

Who may qualify

Ages: 35 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Patients between 35 and 65 years with primary knee OA with malalignment
Mild to moderate OA of grade II or III severity on the Kellgren-Lawrence scale with require treatment by osteotomy
Malalignment is not exceed 15 degree (+,-)
Pain on walking (15 m) ≥ 40 mm.
Range of motion > 90 degree

Key exclusion criteria (9 listed)

Previous surgery on affected knee
Previous intraarticular intervention within the last 3 months (eg. Steroid, anaesthetic, Sodium hyaluronate)
Oral SYSADOA treatment (chondroitin, glucosamine, diacerein) within 2 months prior to study start
Known or suspected infection of the affected joint
Painful knee condition due to another cause than chondral lesions, such as Sudeck's atrophy, intraarticular neoplasm, pigmented villonodular synovitis, chondromatosis

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
Sodium Hyaluronate (Hyalgan)1% Sodium Hyaluronate in prefilled syringe	Drug	Osteotomy plus Hyalgan
Osteotomy aloneno injection	Procedure or surgery	Osteotomy alone

Primary outcome

Joint Space Width
Time frame: 12 months
Global assessment
Time frame: 12 months
assess by Patient and investigator
WOMAC section A, B, C
Time frame: 12 months
Pain score
Rescue medicine consumption
Time frame: 12 months
Diclofenac consumption

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 21 Nov 2012.

Related trials for Knee Osteoarthritis

Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis

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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sodium Hyaluronate (Hyalgan) and Osteotomy alone in people with Knee Osteoarthritis, run by TRB Chemedica 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 6 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 21 Nov 2012. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Joint Space Width (time frame: 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01267214.

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 21 Nov 2012.